CLINICAL TRIAL UPDATE

DRY AMD

• Study: Age-Related Eye Disease Study II (AREDS II)

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing lower dose of zinc and eliminating beta-carotene

Design: Phase 3, randomized, prospective, multicenter trial

Number of Patients: 4000

Number of Clinical Centers: 80 plus

Inclusion Criteria: Age 55 years to 80 years; bilateral large drusen (>125 µm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eye

Exclusion Criteria: Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser)

Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

• Study: OT-551

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To investigate whether the topically applied antioxidant OT-551 can help slow progression of atrophic “dry” AMD

Inclusion Criteria: Age ³50 years; geographic atrophy or the dry form of AMD in both eyes; no history of neovascular or “wet form” of AMD in either eye; have not participated in any other AMD clinical trial except using vitamins; no previous ocular surgery other than cataract surgery; not presently receiving chemotherapy; must be medically stable and able to complete the study; participation requires 7 visits over approximately 2 years, with vision testing and eye exams at each visit

Information: Ruby Lerner, RN

Phone: (301) 451-3437

Fax: (301) 480-2566

E-mail: lernerru@nei.nih.gov

• Study: Measuring Reading Rehabilitation Outcomes

Sponsor: Department of Veteran Affairs

Status: Enrolling patients

Purpose: To measure the effectiveness of a newly-designed oculomotor training program for patients with AMD

Design: Educational, counseling, training, nonrandomized, double-blind, active control, crossover assignment, efficacy study

Number of Patients: 90

Inclusion Criteria: Established preferred retinal locus; visual acuity of less than or equal to 20/70 and greater than or equal to 20/400 (in the better eye)

Exclusion Criteria: Major ophthalmologic and neurologic disease; choroidal neovascularization (“wet” AMD); moderate to severe media opacities; and cognitive impairment

Information: (312) 996-1466

Study: Safety Study in Retinal Transplantation for Dry AMD

Sponsors: Ocular Transplantation, National Neurovision Research Institute

Status: Enrolling patients

Purpose: To show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with dry AMD

Design: Treatment, nonrandomized, open label, active control, factorial assignment, safety/efficacy study

Number of patients: 10

Inclusion Criteria: Decreased entral visual acuity of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye; vision in the nonoperated eye must be better than the operated eye; vision in the operated eye cannot be better than 20/200; >55 years of age; patient has undergone microperimetry and Goldmann visual field testing

Exclusion Criteria: Medical problems that are contraindicatory for short-term anesthesia; pregnancy; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization; history of choroidal neovascularization in the study eye; prior photodynamic therapy or Macugen therapy for choroidal neovascularization; history of uveitis, Coat’s disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole

Information: (502) 636-2823

• Study: Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry AMD

Sponsor: Sirion

Status: Currently enrolling

Purpose: To determine the efficacy of fenretinide in the treatment of geographic atrophy in subjects with the dry form of AMD

Design: Multicenter, randomized, double-masked, placebo-controlled, dose comparison

Number of Patients: 225

Inclusion Criteria: Age from 50 to 89 years old; must have geographic atrophy from AMD in one or both eyes

Exclusion Criteria: Geographic atrophy due to any disease other than AMD

Contact: (813) 957-3449

• Study: RHEO-AMD

Sponsor: Occulogix

Status: Enrolling patients

Purpose: To evaluate Rheopheresis treatment for dry AMD

Design: Multi-center, prospective, randomized, double-masked study comparing safety and efficacy

Number of Patients: 325

Inclusion Criteria: Subjects 50 – 85 yrs and 50 – 100 kg; baseline study eye ETDRS BCVA 20/40 – 20/100 (Snellen equivalent); and, diagnosis of dry AMD in Study Eye with ? 3 soft, semi-soft, or confluent drusen ? 125 µm within 3,000 µm of foveal center (total equivalent drusen surface area ? 31,000 µm2)

Exclusion Criteria: Previous or active Choroidal Neovascularization (CNV); Geographic Atrophy (GA) within 500 µm of foveal center; GA ? 250 µm in diameter; serous (non-drusenoid) pigment epithelium detachment; nongeographic hypopigmentation within 500 µm of foveal center; or, significant opacities causing vision decrease or limiting view of fundus

Information: http://www.occulogix.com/

WET AMD

• Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

Sponsor: (OSI) Eyetech/Pfizer

Status: Enrolling patients

Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment

Design: Treatment, non-randomized, open-label, uncontrolled, single group assignment

Number of Patients: 1000

Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD

Information: (866) 622-8436

• Study: Safety and Efficacy of Repeated Intravitreal Administration of VEGF Trap in Patients with Wet AMD

Sponsor: Regeneron Pharmaceuticals

Status: Enrolling patients

Purpose: To assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal CNV due to AMD

Design: Phase 2, randomized, double-blind, dose comparison, parallel assignment, safety/efficacy

Number of Patients: 150

Inclusion Criteria: Age >50 years; subfoveal CNV secondary to AMD; central retinal (including lesion) thickness ³300 µm as measured by OCT; ETDRS BCVA of 73-34 letters

Exclusion Criteria: History of any vitreous hemorrhage within 4 weeks prior to day 1; aphakia; significant subfoveal atrophy or scarring; prior treatment with the following in the study eye: subfoveal thermal laser therapy, submacular surgery, or other surgical intervention for the treatment of AMD; extrafoveal laser coagulation treatment within 12 weeks prior to day 1; PDT within 12 weeks prior to visit 2 (day 1); pegaptanib sodium within 8 weeks of visit 2 (day 1); juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to visit 2 (day 1); intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to visit 2 (day 1) unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy; prior systemic or intravitreal treatment with VEGF Trap, ranibizumab, or bevacizumab

Information: Regeneron, VEGF.Trap@regeneron.com

• Study: Infliximab, Sirolimus, and Declizumab to Treat AMD

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine whether anti-inflammatory medicines infliximab, sirolimus, or declizumab, when given with a patient’s current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD

Design: Phase 2, open-label, randomized, single center

Number of Patients: 20

Inclusion Criteria: Age >55 years; AMD with drusen ³63 µm; any antiangiogenic therapy in study eye within 7 days of beginning study treatment; vision 20/40-20/400 in study eye; CNV under fovea, as defined by FA features detailed in study criteria; occult CNV with no classic lesions to meet study criteria

Exclusion Criteria: CNV in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis, or posterior uveitis; presence of geographic atrophy under the fovea in the study eye; evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED, or the presence of a connecting retinal vessel; presence of chorioretinal anastomosis; decrease in vision due to retinal disease not attributable to CNV or significant media opacity; presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring >50% of CNV lesion; history of other antiangiogenic treatment or treatment of CNV (not including PDT and pegaptanib sodium) in study eye with TTT or other local treatment; please see complete trial information for additional exclusion criteria

Information: National Eye Institute, prpl@mail.cc.nih.gov

• Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD

Sponsor: Vitreoretinal Macula Consultants of New York; Genentech

Status: Enrolling patients

Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization

Design: Treatment, nonrandomized, open-label, active control, parallel assignment, safety/efficacy study

Number of Patients: 15

Inclusion Criteria: BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone area of the CNV must occupy at least 50% of the total lesion; lesion must be £4000 µm in greatest linear dimension (GLD)

Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to other causes than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids.

Contact: (212) 452-6902

• Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD

Sponsor: The National Retina Institute/Genentech

Status: Enrolling patients

Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD

Number of Patients: 20

Inclusion Criteria: Age >50 years; definite characteristic signs of age related macular degeneration (AMD) including drusen; presence of retinal angiomatous proliferation as determined by clinical signs (intra retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high speed ICG)

Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the non-study eye less than 7 days preceding Day 0; previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Contact: (301) 986-8747

• Study: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

Sponsor: Johns Hopkins University/ Genentech

Status: Enrolling patients

Purpose: To look at the effects of ranibizumab on a condition called “predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)” due to wet AMD

Number of Patients: 10

Inclusion Criteria: Age >50 years old; must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography

Exclusion Criteria: Known hypersensitivity to humanized monoclonal antibodies; history (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment); history of stroke within 6 months of study entry; current acute ocular or periocular infection; any major surgical procedure within 1 month of study entry; known serious allergies to fluorescein dye

Contact: (443) 257-9692

• Study: Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Monotherapy - Intravitreal Ranibizumab Alone for the Treatment of Age-Related Macular Degeneration.

Sponsor: Bay Area Retinal Associates/QLT Inc.

Status: Enrolling patients

Purpose: To compare triple therapy using photodynamic therapy, intravitreal dexamethasone and intravitreal ranibizumab injections vs monotherapy with intravitreal ranibizumab alone for the treatment of AMD.

Study Design: Treatment, Randomized, Single-Blind, Active-Control, Crossover Assignment, Efficacy Study

Number of Patients: 60

Inclusion Criteria: BCVA using ETDRS Charts between 20/40 and 20/320 (Snellen Equivalent) in the study eye with evidence of neovascular AMD; all lesion subtypes will be enrolled with the following criteria: predominantly classic, classic lesion greater than 50% of the total lesion area; less than 12 disc areas; minimally classic or occult: CNVM must be greater than or equal to 50% of the total lesion size; some evidence of recent disease progression (heme, vision loss, recent lesion growth on FA); lesion size must be less than 12 disc areas; lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid; less than12 disc areas in total size; age greater than or equal to 50 years

Exclusion Criteria: Pigment epithelial detachment greater than 50% of the total lesion size; previous treatment for AMD in the study eye; previous intravitreal drug delivery in the study eye; history of vitrectomy in the study eye; fibrosis or atrophy involving the center of the fovea in the study eye; neovascular membrane from any other concurrent retinal disease such as high myopia (SER > -8D), histoplasmosis or other ocular inflammatory disease; known history of glaucoma and on more than one topical medication; history of glaucoma filtering surgery in the study eye; history of corneal transplant in the study eye; patients with co-existing macular disease such as diabetic macular edema; active intraocular inflammation in the study eye; history of allergy to fluorescein not amenable to treatment

Information: (925) 943-6800

• Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration

Sponsor: Novartis/Greater Houston Retinal Research

Status: Currently enrolling

Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD.

Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Number of Patients: 30

Inclusion Criteria: Age > 55 years; subfoveal neovascular membrane confirmed by fluorescein angiography and or ICG; visual acuity not better than 20/32 and not worse than 20/320 by ETDRS refraction

Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12 month study; prior enrollment in any study for AMD

Information: http://www.houstonretina.com/

• Study: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration

Sponsor: Allergan

Status: Currently enrolling

Purpose: To evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration

Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 135

Inclusion Criteria: 50 years or older with “wet” AMD as determined by an ophthalmologist; decrease in visual acuity (20/40 to 20/400) in at least one eye

Exclusion Criteria: Uncontrolled systemic disease; history of heart attack or stroke within one year of study entry; symptomatic coronary artery disease; cataracts that interfere with vision

Information: clinicaltrials@allergan.com

• Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

Sponsor: Novartis

Status: Currently enrolling

Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 318

Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye

Information: Brandi Teske, bteske@westcoastretina.com

SCREENING

• Study: Evaluation and Treatment of Patients with Retinal Disease

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area

Design: Natural history

Number of patients: 500

Inclusion Criteria: Diagnosis of AMD

Exclusion Criteria: Inability to be followed for 3 years

Contact: (800) 411-1222

• Study: Screening for Studies on Retinovascular Diseases

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To help recruit patients for National Eye Institute (NEI) studies of the retina

Design: Natural history

Number of patients: 1500

Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women

Contact: (800) 411-1222

• Study: Screening for Studies on Inherited Eye Diseases

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases

Design: Natural history

Number of Patients: 500

Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study. All studies require the subject to have minimum age of 18 years in both men and women

Contact: (800) 411-1222

• Study: Genetic Factors in AMD

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine whether certain polymorphisms predispose people to develop AMD

Design: Screening

Number of Patients: 400

Inclusion Criteria: (AMD patients) Age ³50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 µm; absence of other diagnostic criteria for AMD

Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of papillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases)

Information: (800) 411-1222

• Study: Investigating Age-Related Macular Degeneration

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To examine an Amish community to investigate genetic factors in the development of AMD

Design: Natural history

Number of patients: 1000

Inclusion Criteria: All Amish individuals, ³50 years

Information: (301) 496-6583

• Study: Ultrasonic Evaluation of Ocular Tissues

Sponsor: Weill Medical College of Cornell University/Riverside Research Institute

Status: Currently enrolling

Purpose: To improve diagnosis and treatment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques

Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study

Number of Patients: 150

Inclusion Criteria: Have one of the following eye diseases: Glaucoma Ocular Tumors Age-Related Macular Degeneration

Information: (212) 746-6106

• Study: Screening for Studies on Inherited Eye Diseases

Sponsor: NEI

Status: Currently enrolling

Purpose: To help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases

Design: Natural History

Number of Patients: 800

Inclusion/Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study

Information: (800) 411-1222

RETINAL IMAGING STUDIES

• Study: Retinal Imaging in Patients With Inherited Retinal Degenerations

Sponsor: University of California-San Francisco/University of California-Berkeley

Status: Enrolling patients

Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope

Design: Natural history, longitudinal, defined population, prospective study

Number of Patients: 130

Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley

Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery

Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu

• Study: Novel Diagnostics for Ocular Structure

Sponsor: University of Pittsburgh/National Institutes of Health

Status: Enrolling patients

Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called optical coherence tomography (OCT).

Design: Natural history, longitudinal, defined population, retrospective/prospective Study

Number of patients: 500

Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma

Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation

Information: Tammy J Capozzoli, (412) 647-2375, capozzolitj@upmc.edu

• Study: Metabolic Mapping to Measure Retinal Metabolism

Sponsor: National Eye Institute

Status: Enrolling patients

Purpose: To test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use)

Design: Diagnostic, nonrandomized, open-label, uncontrolled, single-group assignment, efficacy study

Number of Patients: 30

Inclusion Criteria: Presence of a natural lens in the study eye; age 60 years or older

Exclusion Criteria: Ocular disease (other than AMD) that confounds assessment of the retina including diabetic retinopathy, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration

Information: (800) 411-1222

• Study: AMD DOC Study (Age-Related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization)

Sponsor: Johns Hopkins University

Status: Enrolling patients

Purpose: To compare the ability of the Preferential Hyperacuity Perimeter (PHP) to that of the Amsler grid in detecting neovascular AMD in eyes at high risk for CNV development

Design: Screening, Longitudinal, Defined Population, Prospective Study

Number of patients: 180

Inclusion Criteria: Age ³50; best corrected visual acuity letter score = 65 or greater (approximate Snellen equivalent of 20/50 or better in the candidate study eye); neovascular AMD in the fellow eye and no CNV in the candidate study eye (absence of CNV confirmed by FA which will be graded in a masked fashion by the AMD DOC Study Reading Center); candidate study eye must have evidence of at least 1 large druse (³125 µm) and focal hyperpigmentation within 3600 µm of the fovea and visible on color fundus photography; must have media clear enough in the candidate study eye to permit fundus photography, fluorescein angiography, and optical coherence tomography and absence of any fluorescein allergies.

Exclusion Criteria: Known allergy to fluorescein angiography or allergic reaction during screening; advanced AMD with CNV in both eyes confirmed on FA graded by the AMD DOC Study Reading Center; foveal geographic atrophy in the study eye; significant media opacity that precludes reasonable quality retinal imaging including color fundus photographs, fluorescein angiography, or OCT in the candidate study eye to assess the presence of CNV; evidence of macular disease (eg, pattern dystrophy, diabetic macular edema, vitreomacular traction) other than AMD in the study eye; previous surgical or laser treatment to the macula of the study eye; diabetic retinopathy

Information: (410) 955-3648

• Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging

Sponsor: University of Pittsburgh

Status: Currently enrolling

Purpose: To evaluate optical coherence tomography (OCT) and FDA approved device used to image diseases of the eye

Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study

Number of Patients: 1500

Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and other various eye diseases. Also must be able to fixate on target.

Exclusion Criteria: Fundus not visible or opaque media

Information: (412) 647-2375

DIABETIC MACULAR EDEMA

• Study: Evaluation of Vitrectomy for DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 29

Number of patients: approximately 400

Status: Enrolling patients

Purpose: To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications; to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial; to obtain data that can be used to plan a randomized trial

Design: The study is designed as a prospective cohort study. A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the RCT protocol

Inclusion/Exclusion Criteria: Age ³18 years old, study eye with vitrectomy being performed as treatment of DME, study eye with best corrected visual acuity 20/800 or better (E-ETDRS visual acuity score ³3 letters)

Information: http://public.drcr.net/studies/ProtocolD_vitrectomy/ProtDInfo.html

• Study: An Observational Study of the Development of DME Following Scatter Laser Photocoagulation

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 18

Number of patients: approximately 150

Status: Enrolling patients

Purpose: To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using OCT in eyes without macular edema prior to scatter laser photocoagulation, and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen

Design: Prospective, multicenter, nonrandomized clinical trial

Inclusion/Exclusion Criteria: Age ³18 years, study eye with (1) OCT center point thickness ³200 µm and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either 1 sitting or 4 sittings

Information: http://public.drcr.net/studies/ProtocolF_prp/ProtFInfo.html

• Study: Subclinical DME Study

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 18

Number of patients: Approximately 1000 patients will be enrolled in order to follow 220 patients

Status: Recruiting

Purpose: To determine how often study participants’ eyes with subclinical DME (defined as no edema involving the center of the fovea as determined by biomicroscopy but with center point thickness on OCT of at least 200 µm but less than or equal to 299 µm) progress over a 2-year period to edema on OCT of at least 300 µm (which is almost always clinically apparent) and increase at least 50 µm from baseline or are treated for DME among individuals with more than minimal retinopathy (greater than level 20), and to determine mean OCT retinal thickness measurements and confidence intervals in subjects with diabetes and no or minimal nonproliferative diabetic retinopathy (level 20 or less)

Design: Prospective, multicenter, observational study. The study consists of a baseline phase and follow-up phase

Inclusion/Exclusion Criteria: Age ³18 years, study eye with best corrected E-ETDRS acuity ³74 letters (20/32 or better)

Information: http://public.drcr.net/studies/ProtocolG_subclinical/ProtGInfo.html

• Study: FAME (Fluocinolone Acetonide in Macular Edema)

Sponsor: Alimera Sciences & Controlled Delivery Systems

Number of Sites: Approximately 100

Number of Patients: More than 900

Status: Phase 3 initiated

Purpose: To evaluate the safety and efficacy of sustained-release fluocinolone acetonide, at 2 doses, delivered via the Medidur intraocular sustained delivery system

Design: Double-masked, randomized, multicenter, parallel group, controlled study

Inclusion/exclusion Criteria: Patients diagnosed with DME, who have previously had laser treatment

Information: www.alimerasciences.com

• Study: Reduction in the Occurrence of Center-threatening DME

Sponsor: Eli Lilly and Company

Status: Enrolling patients

Purpose: Determine whether ruboxistaurin can slow the progression of DME

Design: Randomization 1:1, ruboxistaurin/placebo

Inclusion Criteria: Type 1 or type 2 diabetes; >18 years; nonclinically significant DME; mild to moderate diabetic retinopathy in the study eye or vitreous hemorrhage in the study eye; relatively good vision (20/30 or better)

Exclusion Criteria: Surgery or laser treatment in the study eye; glaucoma in the study eye; HbA1c >11%, or systolic blood pressure <170 mm Hg

Information: (877) 285-4559

• Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Sponsor: Rocky Mountain Retina Consultants/Genentech

Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of DME as compared to grid/focal laser

Design: Treatment, randomized, open-label, active control, parallel assignment, efficacy study

Number of Patients: 60

Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991); retinal thickening within 500 mm of the center of the fovea; hard exudates within 500 mm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500 µm limit); area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula; age >21 years; visual acuity < 20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam; retinal thickness on OCT measuring 250 µm or more in the central subfield or 350 µm of more in any non-central subfield; media clarity and pupillary dilatation, patient cooperation, and adequate fundus photographs and OCT will be obtainable; no other ocular conditions that could cause macular edema will be present

Exclusion Criteria: IOP exceeds 25 mm Hg; pregnancy or premenopausal women not using birth control; current treatment of a systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections

Information: (801) 264-4444

• Study: Safety and Tolerability of MS-R001 in Patients With DME Secondary to Diabetic Retinopathy

Sponsor: MacuSight

Status: Currently enrolling

Purpose: To determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Study Design: Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Number of Patients: 30

Inclusion Criteria: Diagnosis diabetes mellitus; visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye; intraocular surgery of the study eye within 90 days prior to study start; capsulotomy of the study eye within 30 days prior to study start

Information: (602) 222-2221 or (817) 749-0180

• Study: Intravitreal vs Sub-Tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders

Sponsor: NEI

Status: Enrolling patients

Purpose: To evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide (TAC-PF) at two dosage levels(4 mg and 8 mg) compared to anterior sub-tenon injections of TAC-PF at 20 mg

Design: Masked, randomized, interventional phase 1 study

Number of Patients: 120

Inclusion Criteria: Retinal thickening due to macular edema in the study eye; retinal thickness greater than or equal to 250 microns in the central subfield on OCT; BCVA equal to or worse than 20/40 in the study eye; sufficiently clear ocular media to permit good quality retinal photographs and angiography to allow assessment of macular area according to standard clinical practice

Exclusion Criteria: IOP greater than25 mm Hg or history suggesting glaucoma or glaucomatous visual field defects as documented by Goldmann or Humphrey perimetry taken within6 months to qualification; allergy to fluorescein dyes; blood pressure greater than 180/110; use of medications known to be toxic to the lens, retina, or optic nerve; previous experimental therapies for the present disease in the past3 months; history of or current acute ocular or periocular infection; major intraocular surgical procedure within1 month of enrollment; use of systemic steroids in excess of an average 20 mg daily dose for the past 3 months; history of untoward complications from corticosteroid therapy, including elevated intraocular pressure in response to topical or periocular corticosteroids

Information: (800) 411-1222

• Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Sponsor: Allergan

Status: Enrolling patients

Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema

Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 860

Inclusion Criteria: Diagnosis of DME; decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); visual acuity in other eye no worse than 20/200

Exclusion Criteria: Known anticipated need for ocular surgery within next12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin

Information: clinicaltrials@allergan.com

• Study: READ-2 (Ranibizumab for Edema of the mAcula in Diabetes)

Sponsor: Johns Hopkins/Juvenile Diabetes Research Foundation/Genentech

Status: Enrolling patients

Purpose: To compare ranibizumab to laser therapy in the treatment of DME

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 125

Inclusion Criteria: Diagnosis of diabetes mellitus; retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by OCT images; foveal thickness of greater than 250, as assessed by OCT; BCVA score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 m)

Exclusion Criteria: Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry; previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry; proliferative diabetic retinopathy in the study eye, with the exceptions of inactive, fibrotic proliferative diabetic retinopathy that has regressed following pan-retinal laser photocoagulation or tufts of NVE less than one disc area with no vitreous hemorrhage; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque; ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause; concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period; eyes that are likely to need cataract surgery and intraocular lens implantation within the first 6 months of the study; cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within2 months of study entry; or any other intraocular surgery within 3 months preceding Day 0; history of vitreoretinal surgery in the study eye within 3 months of study entry; uncontrolled glaucoma or diabetes mellitus; premenopausal women not using adequate contraception or pregnant women; history of gastrointestinal bleeding within 2 months of study enrollment, of major gastrointestinal, cardiothoracic, gynecological, genitourinary, or orthopedic surgeries within 2 months of study enrollment, or of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment; anyone on renal dialysis

Information: (410) 502-1713

• Study: The Course of Response to Focal Photocoagulation for DME

Sponsor: NEI

Status: Currently enrolling

Purpose: To determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME

Design: Longitudinal, Defined Population, Prospective Study

Number of Patients: 110

Inclusion Criteria: Age ³18 years; diagnosis of diabetes mellitus (type 1 or type 2; best corrected E-ETDRS visual acuity letter score ³24 (i.e., 20/320 or better) within 8 days of enrollment; definite retinal thickening due to diabetic macular edema involving the center of the macula

Exclusion Criteria: Significant renal disease; blood pressure > 180/110 (systolic above 180 OR diastolic above 110); edema caused by other than DME; VA loss that would not improve with treatment of macular edema; substantial cataract

Information: (866) 372-7601

RETINAL VEINOCCLUSION

• Study: The Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) Study

Sponsor: National Eye Institute/National Institutes of Health/Department of Health and Human Services

Status: Enrollment began in October 2004

Purpose: To compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with CRVO and BRVO

Design: Multicenter, randomized, phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of 3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide, or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. The preparation of triamcinolone acetonide used in the study is specially made for injection into the eye and does not contain any preservatives

Inclusion/Exclusion Criteria: Participants with macular edema associated with CRVO and BRVO who are 18 years of age or older and are willing to provide consent. Detailed inclusion/exclusion criteria are available on the SCORE Web site at http://spitfire.emmes.com/study/score

Number of Patients: 1260; 630 with CRVO and 630 with BRVO

Site(s): 27

Information: (301) 251-1161

• Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion

Sponsor: Greater Houston Retina Research

Status: Enrolling patients

Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic central retinal vein occlusion

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 20

Inclusion Criteria: Ischemic CRVO within 3 months of enrollment as per the following inclusion criteria; VA 20/200 or worse; RAPD 0.9 LU or worse; loss of1-2e isopter on Goldmann Visual field; ERG demonstrating B-wave amplitude less than 60% of A wave

Exclusion Criteria: Angle neovascularization greater than 3 clock hours with IOP over 30 (Neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (diabetic macular edema, proliferative diabetic retinopathy, or high-risk non-proliferative diabetic retinopathy); pregnancy

Information: (713) 524-3434

• Study: Lucentis for Macular Edema Secondary to Vein Occlusions

Sponsor: Johns Hopkins/Genentech

Status: Enrolling patients

Purpose: To assess the bioactivity of3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 40

Inclusion Criteria: Diagnosis of macular edema due to central or branch retinal vein occlusion; BCVA in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

Exclusion Criteria: Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry; previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium [EYE001], ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) within3 months of study entry; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; ocular inflammation (including 1+ or above in the amount of cells) in the study eye; history of idiopathic or autoimmune uveitis in either eye; structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque; ocular disorders in the study eye that may confound interpretation of study results, including diabetic retinopathy, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia); concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period; ontraocular surgery in the study eye within 3 months of study entry; uncontrolled glaucoma; infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection; blood pressure exceeding 160/95 (sitting) during the screening period; renal failure requiring dialysis or renal transplant; premenopausal women not using adequate contraception; previous participation in other studies of investigational drugs (excluding vitamins and minerals) within 3 months

Information: (410) 955-5106

• Study: Lucentis for Central Retinal Vein Occlusion (CRVO)

Sponsor: California Retina Consultants/Genentech

Status: Enrolling patients

Purpose: To determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study

Number of Patients: Contact company

Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants; central macular edema present on clinical examination and OCT testing with a central point thickness >250 µm; visual acuity score greater than or equal to19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria: Pregnant women or premenopausal women not using adequate contraception; uncontrolled hypertension; significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy; evidence of vitreoretinal interface abnormality that may be contributing to the macular edema; presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study; evidence of neovascularization of the iris or retina (presence of ischemic CRVO); presence of substantial cataract, one that might decrease the vision by3 or more lines of vision at sometime during the study; history of Grid/Focal laser or Panretinal laser in the study eye; history of vitreous surgery in the study eye; history of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study; history of Cataract Surgery within 6 months of enrollment; history of YAG capsulotomy within 2 months of the surgery; visual acuity <20/400 in the fellow eye; uncontrolled glaucoma

Information: (805) 963-1648 x26

• Study: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Sponsor: Allergan

Status: Enrolling patients

Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion

Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Number of Patients: 650

Inclusion Criteria: Eighteen years of age or older with macular edema resulting from retinal vein occlusion; decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse); visual acuity in other eye no worse than 20/200

Exclusion Criteria: Known anticipated need for ocular surgery within next12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; diabetic retinopathy; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin

Information: clinicaltrials@allgeran.com

OTHER

• Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration

Sponsor: Ophthalmic Consultants of Boston/Genentech

Status: Currently enrolling

Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular degeneration

Study Design: Treatment, Randomized, Single-Blind, Dose Comparison, Factorial Assignment, Safety/Efficacy Study

Number of Patients: 30

Inclusion Criteria: Active CNV

Exclusion Criteria: pregnancy, age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Information: (617) 573-1021

COMPLETEDENROLLMENT

• Study: Age-Related Macular Degeneration and Cataract

Sponsor: NEI

Information: http://clinicalstudies.info.nih.gov/detail/B_1992-EI-0250.html

• Study: Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders

Sponsor: NEI

Information: http://clinicalstudies.info.nih.gov/detail/B_2004-EI-0013.html

• Study: Lutein/Zeaxanthin and Omega-3 Supplementation in Persons Over Age 60

Sponsor: NEI

Information: http://clinicalstudies.info.nih.gov/detail/B_2005-EI-0073.html

• Study: A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF) in Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration

Sponsor: NEI

Information: http://clinicalstudies.info.nih.gov/detail/B_2006-EI-0071.html

• Study: Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema

Sponsor: NEI

Information: http://clinicalstudies.info.nih.gov/detail/B_2003-EI-0291.html

• Study: Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate

Sponsor: University of Iowa

Information: http://www.clinicaltrials.gov/ct/show/NCT00349739?order=1

• Study: Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)

Sponsor: Alcon/Manhattan Eye, Ear & Throat Hospital

Information: http://www.clinicaltrials.gov/ct/show/NCT00211419?order=2

• Study: Identification and Treatment of Feeder Vessels in AMD

Sponsor: NEI

Information: http://www.clinicaltrials.gov/ct/show/NCT00018070?order=1

• Study: Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation

Sponsor: NEI

Information: http://www.clinicaltrials.gov/ct/show/NCT00105404?order=2

• Study: Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders

Sponsor: NEI

Information: http://www.clinicaltrials.gov/ct/show/NCT00071227?order=17

• Study: Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders

Sponsor: NEI

Information: http://www.clinicaltrials.gov/ct/show/NCT00071227?order=16

COMPLETED TRIALS

• Study: Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)

Sponsor: NEI

Results: Available at http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=70

Study: A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

Sponsor: Genentech

Results: Available at: http://clinicalstudyresults.gene.com/fvf3192g.pdf

• Study: A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration

Sponsor: Genentech

Results: Available at http://clinicalstudyresults.gene.com/fvf2598g.pdf

• Study: Central Vein Occlusion Study (CVOS)

Sponsor: NEI

Results: Available at http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=30

• Study: Branch Vein Occlusion Study

Sponsor: NEI

Results: Available at http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=64