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 �50 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; fisual 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 one eye by ETDRS vision testing for a duration of at least one 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
| 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: 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: Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15 mg Dose for Long-Term Use in Patients With AMD
Sponsor: Alcon
Status: Enrolling patients
Purpose: To study the efficacy of anecortave acetate 15 mg administered every 6 months over 24 month in treating wet AMD
Design: Treatment, non-randomized, open-label, uncontrolled, single group assignment, safety/efficacy study
Number of Patients: 150
Inclusion Criteria: Patients with subfoveal exudative age-related macular degeneration (AMD) who were enrolled in Alcon Study C-98-03
Information: (817) 568-6747, intldev@alconlabs.com
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 �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, 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 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: 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: Enrolling patients
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: Enrolling patients
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: Multicentered, 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: Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial
Sponsor: LuEsther T. Mertz Retinal Research Center
Status: Enrolling patients
Purpose: Evaluate the effect of PDT 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, 1 mg of triamcinolone/PDT, 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 �50 years;
in the study eye, diagnosis of AMD defined by the presence of drusen larger than
63 μm; visual acuity of 20/40 to 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 chorioretinal 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: 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
Study: Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab vs Monotherapy - Intravitreal Ranibizumab Alone for the Treatment of AMD
Sponsor: Bay Area Retina Associates, QLT, Inc.
Status: Enrolling patients
Purpose: To compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal Ranibizumab alone for the treatment of AMD.
Design: Treatment, randomized, singleblind, active control, crossover assignment, efficacy study
Inclusion Criteria: Minimally classic or occult lesions; Classic lesions greater than 50% of the total lesion area; lesion must be less than 12 disc areas; CNVM must be greater than or equal to 50% of the total lesion size; some evidence of recent disease progression; occult lesions must show recent activity progression with respect to vision, subretinal hemorrhage or subretinal fluid and be less than 12 disc areas in total size; age >= 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 corneal transplant in the study eye; co-existing macular disease such as DME;
active intraocular inflammation in the study eye; history of allergy to fluorescein
Contact:
(925) 943-6800
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 diopters), or choroidal neovascularization secondary to other causes than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids.
Contact: (212) 452-6902
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, ages 50 and older
Information: (301) 496-6583
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 & 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: Ultrasonic Evaluation of Ocular Tissues
Sponsor: Weill Medical College of Cornell University/Riverside Research Institute
Status: Enrolling patients
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: Diagnosis of AMD
Contact: (212) 746-6106
Study: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Sponsor: Johns Hopkins University/ Genentech
Status: Enrolling patients
Purpose: To look at the effects of an experimental drug, 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
one month of study entry; known serious allergies to fluorescein dye
Contact: (443) 257-9692
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
| 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
| 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: Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy
Sponsor: University of California, Los Angeles
Status: Enrolling patients
Purpose: To investigate imaging of intraocular tumors that may lead to improved diagnosis and monitoring of tumors within the eye
Study Design: Longitudinal, defined population, prospective study
Inclusion Criteria: Adults (18 years
or older) with choroidal nevus greater than or equal to 3.0 mm in longest basal
diameter, or greater than or equal to
1.25 mm in apical height; or choroidal
melanoma located in the posterior pole (4 mm or less from the center of fovea or
the border of the optic nerve head)
Exclusion Criteria: Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging
Contact: (310) 206-7484
| 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 �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: 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 �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 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 �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: 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: Macugen in Diabetic Macular Edema and Diabetic Retinopathy
Sponsor: (OSI) Eyetech
Status: Enrolling patients
Purpose: To compare the safety and efficacy of Macugen in patients with DME
Design: Phase 3, randomized, controlled, double-masked, multicenter, comparative, dose finding
Number of Patients: Planned enrollment is 900
Site(s): 41
Information: 212-824-3100
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
| 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
Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Sponsor: Palmetto Retina Center, LLC/Pfizer/Eyetech Pharmaceuticals
Status: Enrolling patients
Purpose: To evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.
Number of Patients: 30
Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness greater than or equal to 250 μm using the OCT-3; less than 25% of foveal capillary ring disruption and less than 2 disc areas of capillary non-perfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center
Exclusion Criteria: Ocular conditions
other than BRVO related macular edema; intraocular surgery within past
3 months;
significant enlargement of foveal avascular zone (>25% disruption of capillary
ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal
center; likelihood of evidence driven indication for peripheral photocoagulation
in the next 6 months; evidence of spontaneous improvement within the preceding 3
months, as determined by an improvement of >15 letters of vision or thinning
of the Center Point on OCT of >20% from baseline determination; prior grid laser
within 4 months of baseline or more than one prior grid laser treatment; prior intravitreous
or periocular steroid injections in the study eye.
Information: (803) 931-0077
| COMPLETED TRIALS |
Study: Macugen for Macular Edema Associated With CRVO
Sponsor: OSI/Eyetech/Pfizer
Number of Patients: 90
Information: (212) 824-3204
Results: Available at http://www.visionconnection.org/Content/ForProfessionals/News/MacugenandMacularEdema.htm
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