CLINICAL TRIAL UPDATE

DRY AMD

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

Sponsor: National Eye Institute

Status: Enrolling patients as of May/June 2006

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 greater than or equal to 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 50 years or older; 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: Anecortave Risk-Reduction Trial (AART)

Sponsor: Alcon Laboratories, Inc.

Status: Enrolling patients

Purpose: A 48-month study of posterior juxtascleral administrations of anecortave acetate 15 mg, 30 mg, or sham administrations every 6 months

Design: Randomized, double-blind

Number of Patients: 24

Inclusion Criteria: Age >50 years; dry AMD in study eye, wet AMD in non-study eye

Information: Alcon; (817)568-6747

E-mail: inteldev@alconlabs.com

►Study: CNTF Implants for People with Vision Impairment Due to Atrophic AMD

Sponsor: National Eye Institute

Status: Enrolling Patients

Purpose: To investigate the effects of CNTF implants in patients with vision impairment due to atrophic AMD

Inclusion criteria: BCVA in the study eye <20/63�20/160 (58 to >39 letter score) as measured EVA; Presence in the study and/or fellow eye of angiographic atrophy (GA)

Exclusion Criteria: Less than 50 years of age; medically unable to comply with study tests or follow-up visits; evidence of ocular disease other than AMD (eg, diabetic retinopathy, central serous chorio-retinopathy, uveitis, pathologic myopia, glaucoma); evidence of and history of treatment for CNV other than antioxidant vitamins and minerals; previous intraocular surgery except for cataract surgery; participation in any other clinical trial for AMD (except for vitamin therapy); inability to obtain quality fundus photographs; history of ocular herpes simplex virus

Information: Renee Gaiter, RN, BSN

Phone: (301) 594-9825

Fax: (301) 435-1629

E-mail: gaiter@nei.nih.gov

►A Study: NT-501

Sponsor: Neurotech

Status: Enrolling patients

Purpose: To evaluate the efficacy and safety of the CNTF implant

Design: Phase 2, randomized, double-masked, sham-controlled, dose-ranging study

Site(s): 1

Information: (212) 213-0006

WET AMD

►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 �300 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

E-mail: 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 �63 mm; 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 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 greater than 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

E-mail: prpl@mail.cc.nih.gov

►Study: ADVANCE: Study of Vatalanib and Photodynamic Therapy with Verteporfin in Patients with Subfoveal CNV Secondary to AMD

Sponsor: Novartis

Status: Enrolling patients

Purpose: To test the safety of vatalanib in combination with verteporfin in patients with CNV forming beneath the macula due to AMD

Design: Phase 1/2, randomized, double-blind

Inclusion Criteria: Age >65 years; wet AMD; size of lesion must be �5400 μm; if minimally classic type or occult only type, lesion must be �6 disc areas and must have recent disease progression; 20/40-20/320

Exclusion Criteria: Prior treatment in study eye for CNV; uncontrolled high blood pressure, despite chronic stable treatment; systolic �140 mm Hg, diastolic �90 mm Hg; history of ECG abnormalities

Information: http://clinicaltrials.gov/ct/show/NCT00138632?order=39

►Study: A Study to Evaluate Ranibizumab in Subjects with CNV Secondary to AMD (SAILOR)

Sponsor: Genentech

Status: Enrolling patients

Purpose: (Primary) To estimate the incidence of ocular and non-ocular serious adverse events in subjects treated with intravitreal ranibizumab; (Secondary) To estimate the incidence of ocular and non-ocular adverse events and the proportion of subjects with a decrease from baseline in BCVA of at least 15 letters at month 12

Design: Phase 3b, single-masked multicenter, randomized

Number of Patients: 5000

Inclusion Criteria: Age >50 years; signed consent form; subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following: �5 letters of BCVA lost within 6 months preceding day 0; �10% increase in lesion area, as determined by FA performed within 1 month preceding day 0 to FA performed within 6 months preceding day 0; classic CNV compromising >50% of CNV lesion area; BCVA using EDTRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40-20/320 in the study eye

Exclusion Criteria: Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the study eye <30 days preceding day 0; history of submacular surgery or other surgical intervention for AMD in study eye; previous participation in any studies of investigational drugs within 30 days preceding day 0 (excluding vitamins and minerals); prior participation in a Genentech ranibizumab clinical trial; treatment with intravitreally administered Avastin within 30 days preceding day 0; concurrent use of systemic anti-VEGF drugs; fibrosis or atrophy involving the center of the fovea in the study eye, in the absence of a new lesion; CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia; RPE tear involving the macula in the study eye; any concurrent intraocular condition, active intraocular inflammation or current VH in the study eye; history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in study eye; history of idiopathic or autoimmune-associated uveitis in either eye; active infectious keratitis, scleritis, or endophthalmitis in either eye; aphakia or pseudophakia with absence of the posterior capsule; spherical equivalent of the refractive error in study eye demonstrating within 2 months preceding day 0; uncontrolled glaucoma in study eye; concurrent use of more than 1 therapy for glaucoma; glaucoma filtering surgery or corneal transplant in study eye; history of other disease, metabolic dysfunction, physical examination finding, or clinical lab finding to contraindicate the use of an investigational drug that might affect interpretation of the results or render the subject at high risk for treatment complications; current treatment for significant active 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; inability to comply with study or follow-up procedures

Information: (888) 662-6728

►Study: A Clinical Trial to Explore the Safety and Efficacy of 3 Different Doses of Pegaptanib Sodium in Patients with Wet AMD

Sponsor: (OSI) Eyetech/Pfizer

Status: Recruiting

Purpose: To compare the ability of 3 different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD; the study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD

Design: Phase 4, randomized, double-blind

Number of Patients: 262

Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD; BCVA in the study eye between 20/40-20/320; normal electroretinogram and corneal endothelial cell density of 1500 cells/mm² or more

Exclusion Criteria: Any prior PDT with Visudyne or thermal laser to the study eye

Information: (866) 622-8436

►Study: Macugen Alone, vs Macugen in Combination with PDT with Visudyne in Patients with AMD

Sponsor: (OSI) Eyetech/Pfizer

Status: Recruiting

Purpose: To compare whether Macugen in combination with PDT with Visudyne is safe and effective in slowing the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone

Design: Phase 3b/4, randomized, double-blind

Number of Patients: 360

Inclusion Criteria: Age >50 years; subfoveal CNV due to AMD with predominantly classic lesion composition; BCVA in the study eye between 20/40-20/200

Exclusion Criteria: Any prior PDT with Visudyne or AMD thermal laser to the study eye

Information: (866) 622-8436

►Study: MRVT-920101-OPH005

Sponsor: Miravant Pharmaceuticals, Inc.

Status: Recruiting

Purpose: Confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy in the treatment of classic and occult subfoveal choroidal neovascularization
associated with AMD

Design: Multi-centered, multinational, randomized, double-masked, placebo-controlled, phase 3

Number of Patients: 660

Site(s): Multiple European Union and non-European locations

Inclusion Criteria: Age >50 years; at least 1 subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography; best corrected VA score of 20/40�20/200

Information: (800) 685-2959

►Study: SIRNA 0401

Sponsor: Sirna Therapeutics, Inc., Boulder, Colo

Status: Enrolling patients

Purpose: Assess the safety and tolerability of Sirna-027; assess the presence of Sirna-027 in plasma; determine the range of doses for the phase 2 clinical trial; and assess biological and anatomical changes in the retina

Design: Phase 1, open-label, dose-escalation: 4 to 6 dose cohorts, 1 intravitreal injection

Number of Patients: 12�30

Site(s): 4�Wilmer Eye Institute, Baltimore, Md; Massachusetts Eye and Ear Infirmary, Boston, Mass; Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio, Jules Stein Eye Institute, UCLA, Los Angeles, Calif

Inclusion/Exclusion Criteria: 50 years of age or older; subfoveal to AMD, classic and/or occult; no other causes of CNV; total lesion size 12 MPS disc area; subretinal hemorrhage <50% of lesion; subfoveal scarring <50% of lesion; lesion thickness 250 μm; IOP 25 mm Hg; visual acuity 20/100 to 20/800 ETDRS; fellow eye visual acuity not worse than 20/800 ETDRS

Information: (720) 406-2963

►Study: Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial

Sponsor: LuEsther T. Mertz
Retinal Research Center

Status: Recruiting

Purpose: Evaluate the effect of photodynamic therapy in conjunction with intravitreous triamcinolone acetonide in subjects with occult or minimally classic subfoveal CNV secondary to AMD

Design: Randomization 1:1:1, PDT and 0 mg of triamcinolone/PDT and 1 mg of triamcinolone/PDT and 4 mg of triamcinolone

Inclusion Criteria: Age >50 years; occult or minimally classic subfoveal CNV, presence of blood associated with the lesion, vision loss or growth of lesion objectively recorded within preceding 3 months; baseline VA score between 20/40�20/400, lesion �5400 μm

Exclusion Criteria: Predominantly classic CNV, additional eye disease, CNV not involving geometric center of FAZ, inability to be photographed; fluorescein allergy; photophobia; lens opacities expected to progress during study; previous treatment for CNV, other than confluent laser photocoagulation (eg, PDT, submacular surgery, radiotherapy, macular grid); participation in another clinical trial; IOP >21 mm Hg on or off meds; prior treatment with another antiangiogenic compound within
6 months of screening; inability to comply with all study-related procedures; concomitant therapy with systemic or topical corticosteroids or NSAIDs (chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study); a low dose of ASA (up to 100 mg PO qd) taken for prophylaxis of MI and/or stroke is permitted during the study; concomitant coumadin therapy

Number of Patients: 120

Information: Namrata Saroj, (202) 605-3777

►Study: Preservative-free Triamcinolone Acetonide (PFTA)

Sponsor: QLT Inc., National Eye Institute

Status: Enrolling patients

Purpose: Investigate the long-term safety and potential efficacy of PFTA in patients with wet AMD (all types) undergoing Visudyne therapy

Design: Phase 3, randomized, prospective

Number of Patients: 300

Inclusion Criteria: Age greater than or equal to 50 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; visual acuity of 20/40 - 20/200 (73-34 letter score) as measured on an ETDRS chart; in the study eye, the presence of choroidal neovascularization under the fovea

Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; the presence of a chorio-retinal anastomosis; presence of fibrosis, hemorrhage, pigment epithelial detachments, and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion

Information: (301) 496-5248

►Study: Squalamine

Sponsor: Genaera Corporation

Status: Enrolling patients

Purpose: Evaluate the safety and efficacy of intravenously administered squalamine as a first-line therapy for wet AMD

Design: Phase 2, randomized, double-masked, controlled study; 2 dose levels once weekly for 4 weeks, followed by maintenance doses once every 4 weeks through week 48; at the end of therapy, each patient will be followed for an
additional year

Number of Patients: 100

Site(s): Multicenter

Information: (610) 941-4020

►Study: Safety and Efficacy of AG-013958 in Subjects with Subfoveal CNV Associated with Age-related Macular Degeneration

Sponsor: Pfizer

Status: Recruiting

Purpose: Assess the safety, efficacy, and pharmacokinetics of the investigational drug AG-013958 in subjects with exudative AMD

Design: Phase 1/2, randomized, masked, single and multiple-dose, single and multiple-dose, sequential dose-escalation

Inclusion Criteria: �55 years of age; AMD, minimally classic & occult-classic eligible in stage 2 of study (after first 46 pts); no subfoveal fibrosis; total lesion fibrosis or scar <25% total area; hemorrhage <50% of total lesion area; total lesion area �9 DA; ETDRS best corrected score of approximately 20/40-20/230; fellow eye VA �24 letters (20/320 or better); normal ECG or nonsignificant changes

Exclusion Criteria: Prior PDT <3 months before entry; serous pigment epithelial detachment without surrounding neovascularization; diabetic retinopathy, glaucoma, or other serious ocular diseases or conditions; prior subfoveal photocoagulation of the macula; prior intravitreal, sub-Tenon's, or systemic therapy for AMD; prior TTT (transpupillary thermotherapy) or intravitreal steroids in study eye or likely to undergo these procedures within 6 months of entry; cataract surgery within previous 12 months; intraocular surgery within previous 3 months; prior vitrectomy or submacular surgery; prior scleral buckling, myopia �6 D; sitting BP >159/99 mm Hg on 2 out of 3 evaluations; stroke within the previous 12 months; h/o severe cardiac disease; peripheral vascular disease; unstable angina; MI within 6 months; ventricular tachycardia requiring treatment; inability to stop anticoagulants 4 days prior to injection (ASA okay to continue); participation in any clinical trials within the previous
60 days; use of systemic steroids currently or within the previous 30 days

Information: Retina Associates of Cleveland, (216) 831-5700

►Study: AdGVPEDF.11D in Neovascular Age-Related Macular Degeneration (Wet AMD)

Sponsor: GenVec, Inc.

Status: Part 1 is complete; Part 2 is enrolling patients

Purpose: To assess the safety, tolerability and feasibility of single direct intravitreal injection of AdPEDF, identify an appropriate dose range for phase 2 testing of AdPEDF and assess the biologic activity of AdPEDF.

Design: Phase 1, open-label, dose-escalating study of a single intravitreal administration of AdPEDF. Part 1 of the study is complete; AdPEDF (at 8 ascending dose levels) was administered to 28 patients with severe wet AMD and was generally well-tolerated at all dose levels, with no dose-limiting toxicities, endophthalmitis, retinal or vitreous detachment, cataracts or glaucoma. Part 2 will treat 20 additional patients with less advanced (moderate to severe) wet AMD at 2 of the highest doses tested in part 1

Inclusion Criteria: Patients of at least 50 years in age, with moderate to severe wet AMD (best corrected vision of 20/40 to 20/320 in the most impaired eye); active leakage or CNV with lesion diameter less than or equal to 5400 μm and no significant subretinal fluid, who are not candidates for, or who have refused treatment with, subfoveal laser photocoagulation or PDT

Exclusion Criteria: Significant retinal disease other than neovascular AMD; significant non-retinal disease; cataract or other significant media opacity; other causes of choroidal neovascularization such as pathologic myopia (>8 D), ocular histoplasmosis or angioid streaks; evidence of inflammation (grade 1 or higher) in the anterior and/or posterior chambers; cataract surgery or submacular surgery within 3 months; prior ocular treatment with radiation; known allergy to fluorescein; liver enzymes >2 x ULN (ALT, AST, bilirubin); clinical evidence of active infection of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus; other treatment for AMD in the study eye within the last 12 weeks prior to Day 1; other experimental medications within the last 4 weeks prior to Day 1; abnormal prothrombin or partial thromboplastin time (>1.5 x ULN) or anticoagulant therapy that cannot be withheld for treatment; prior or current glaucoma or any atrophic change in the fovea

Number of Patients: Up to 48

Number of Site(s): Seven (7)- Wilmer Eye Institute, Baltimore, Md, Jules Stein Eye Research Center, Los Angeles, Calif, Kresge Eye Institute, Detroit, Mich, Casey Eye Institute, Portland, Ore, University of Washington, Seattle, Wash, Cullen Eye Institute/McPherson, Houston, Texas, Florida Eye Microsurgical Institute, Inc., Boynton Beach, Fla

Information: (240) 632-5591, rdibartolomeo@genvec.com, www.genvec.com

►Study: Interval Dose Evaluation of Anecortave Acetate (IDEAA)

Sponsor: Alcon

Status: Recruiting

Purpose: Compare anecortave acetate

15 mg administered every 3 months vs anecortave acetate 15 mg administered every 6 months vs anecortave acetate

30 mg administered every 6 months in patients with exudative AMD

Design: Prospective, randomized 1:1:1

Inclusion Criteria: Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal CNV lesion, lesion area �12 disc areas; (30.5 mm) of any lesion type (predominantly classic, minimally classic, or occult), choroidal neovascularization (CNV) �50% of the total lesion progression for occult lesions (defined as having experienced a loss of at least 1 line of vision or change in lesion size of more than 1 disc area [2.54 mm] or the appearance of new blood in the lesion within the past 3 months); snellen equivalent of 20/40 to 20/200 visual acuity in the study eye (no vision criteria for the non-study eye).

Exclusion Criteria: Amblyopia; uncontrolled glaucoma with an IOP >30 mm Hg; ischemic optic neuropathy; PDR, clinically relevant NPDR; clinically relevant diabetic macular edema; significant active uveitis; clinical signs of myopic retinopathy, or refraction of �8 D in the patient's current Rx; more than 1 PDT treatment in the study eye; extrafoveal or juxtafoveal thermal laser treatment less than 30 days prior to enrollment, more than 2 Macugen injections in the study eye; more than 1 triamcinolone treatment in the study eye; previous treatment with anecortave acetate in the study eye; intraocular surgery in the study eye within 60 days prior to enrollment; scleral buckle in the study eye; any previous systemic antiangiogenic therapy for AMD; radiation treatment in the study eye; scleral thinning; any unstable medical condition that would preclude ability to keep study visits; coumadin therapy that cannot be interrupted for a 5-day period

Information: Alcon, (866) 692-5959

►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 �50 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

DIABETIC MACULAR EDEMA

►Study: A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)

Sponsor: National Eye Institute

Number of patients: 100

Status: Recruiting

Purpose: To provide preliminary data on the dose and dose-interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with DME to aid in planning a phase 3 trial; to provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME

Design: Randomized, single-blind

Inclusion Criteria: �18 years; type 1 or 2 diabetes mellitus; BCVA �24 and �78; definite retinal thickening due to central DME; OCT central subfield �275 μm

Information: Ingrid U. Scott, MD

E-mail: iscott@psu.edu

►Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema

Sponsor: Eli Lilly and Company

Number of patients: 220

Status: Recruiting

Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce baseline to endpoint changes in macular thickness, as measured by OCT in patients with clinically significant macular edema

Design: Randomized, double-blind, placebo control

Inclusion Criteria: �18 years; type 1 or 2 diabetes; HbA1c �11%; mild to severe non-proliferative diabetic retinopathy in study eye; clinically significant macular edema in study eye

Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in study eye; glaucoma in study eye; unstable cardiovascular disease; major surgery within past 3 months; significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy

Information: (877)285-4559

►Study: Evaluation of Vitrectomy for DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Number of sites: 29

Number of patients: approximately 400

Status: Recruiting

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 �18 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 �3 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: Recruiting

Purpose: To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography (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, multi-center, nonrandomized clinical trial

Inclusion/Exclusion Criteria: Age �18 years, study eye with (1) OCT center point thickness �200 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 non-proliferative diabetic retinopathy (level 20 or less)

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

Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected
E-ETDRS acuity �74 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: over 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, multi-center, 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: Recruiting

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; non-clinically significant diabetic macular edema; 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: IVTA and Laser Photocoagulation for DME

Sponsor: Diabetic Retinopathy Clinical Research Network

Status: Recruiting

Sites: 98

Purpose: Determine whether IVTA at doses of 1 mg or 4 mg provides greater benefit, with an acceptable safety profile, than macular laser in the treatment of DME

Design: 1 eye eligible: randomization, 1:1:1, laser/1 mg triamcinolone/4 mg triamcinolone. Both eyes eligible: 1 eye randomized to laser, the other to 1 mg or
4 mg of triamcinolone

Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected E-ETDRS acuity >24 letters (20/320 or better) and <68 letters (worse than 20/40), study eye with center-involved DME present on clinical exam and on OCT, mean retinal thickness on 2 OCT measurements >250 μm in the central subfield, fellow eye either eligible or has acuity >19 letters (20/400 or better) has not been previously treated with intravitreal corticosteroids

Number of Patients: 795

Site(s): 98

Information: http://public.drcr.net/studies/ProtocolB_steroid/ProtBInfo.html

►Study: Macugen in Diabetic Macular Edema and Diabetic Retinopathy

Sponsor: (OSI) Eyetech

Status: Enrolling

Purpose: To compare the safety and efficacy of Macugen in patients with DME

Design: Phase 3, randomized, controlled, double-masked, multi-center, comparative, dose finding

Number of Patients: Planned enrollment is 900

Site(s): 41

Information: 212-824-3100

MYOPIC MACULAR DEGENERATION

►Study: Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects with Pathologic Myopia

Sponsor: OXiGENE, Inc.

Status: Recruiting

Purpose: Myopic macular degeneration (MMD) is a progressive eye disease caused by thinning of the retina and underlying support tissue as the eye is stretched and elongated. The purpose of this study is to evaluate the safety and dose response of Combretastatin A4 Phosphate (CA4P), an investigational drug, in patients with active choroidal neovascularization secondary to myopic macular degeneration

Design: This phase 2 clinical trial is an open label, dose-ranging, international, multicentered study. Drug is administered intravenously

Number of Patients: 36

Sites: 15

Inclusion Criteria: 18�50 years of age, patients must have pathologic myopia presenting refractive error of -6 D or more correction required OR an axial length of the eye >26.5 mm, area of choroidal neovascularization within 50 μm or under the geometric center of the foveal-avascular zone, BCVA in the study eye of 20/20 to 20/200, inclusive in the qualifying eye (by ETDRS measurement)

Exclusion Criteria: Patients must not be currently pregnant, planning a pregnancy, patients must not have received any previous experimental procedure in either eye or have used any investigational drug or treatment within 30 days prior to enrolling in this trial

Information: www.oxigene.com

CENTRAL RETINAL VEIN OCCLUSION

►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

COMPLETED TRIALS

WET AMD

►Study: MSI-1256F-209

Sponsor: Genaera Corporation

Number of Patients: 40

Sites: 1

Information: (610) 941-4020

Results: Available at www.genaera.com/pressreleases/2003_Oct7.html

►Study: Combretastatin A-4 Phosphate (CA4P) in Patients with Neovascular AMD (FBO-206)

Sponsor: OXiGENE

Number of Patients: 15�20

Site(s): 1, Wilmer Eye Institute, Baltimore, Md

Information: (781) 547-5912

Results: Available at www.oxigene.com

►Study: ANCHOR

Sponsor: Genentech

Number of Patients: 423

Site(s): 100

Information: (888) 662-6728

Results: 1-year results available at: www.gene.com

►Study: MARINA

Sponsor: Genentech

Number of Patients: 716

Site(s): 100

Information: (888) 662-6728

Results: Available at: www.gene.com

►Study: Evaluation and Tolerability of 4-dose Levels of Cand5 Administered by Single Intravitreal Injection in Patients with Wet AMD

Sponsor: Acuity Pharmaceuticals

Number of Patients: 15

Site(s): 2

Information: (215) 966-6191

Results: www.acuitypharm.com

►Study: PIER

Sponsor: Genentech

Number of patients: 184

Site(s): 3

Information: For inquiries about clinical trials, please submit a request through our information request form or call (888) 662-6728. For international inquiries, contact our international collaborator, Novartis Ophthalmics, at (866) 393-6336; www.novartisophthalmics.com

Results: Available at: www.gene.com

DIABETIC MACULAR EDEMA

►Study: EOP-1005

Sponsor: (OSI) Eyetech and Pfizer Inc.

Number of Patients: 169 (included in safety population); 172 (randomized)

Site(s): 41

Information: (212) 824-3100

Results: Published in the October issue of Ophthalmology

A Study: Laser Photocoagulation for DME

Sponsor: Diabetic Retinopathy Clinical Research Network (DRCR.net)

Number of Patients: 263

Site(s): 78

Information: http://public.drcr.net/studies/ProtocolA_laser/ProtAInfo.html

Results: Not currently available