Article Date: 5/1/2007

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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: Othera
Status: Enrolling patients
Purpose:
To investigate whether the topically applied antioxidant OT-551 can help slow progression of atrophic “dry” AMD
Study Design: Randomized, doublemasked, dose-ranging, multi-center, efficacy and safety study
Number of Patients: 200
Inclusion Criteria:
55 or more years of age; clinical diagnosis of geographic atrophy in one or both eyes; area of the geographic atrophy does not exceed 7 MPS disc areas; best corrected visual acuity score of 20/63 (Snellen equivalent) or better; geographic atrophy is not secondary to conditions other than AMD; no choroidal neovascularization in either eye; no confounding ocular conditions or recent or planned surgery in the study eye.
Information: Al Reaves, MD, reaves@othera.com
▪ 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/
▪ Study: A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
Sponsor:
Neurotech Pharmaceuticals
Status: Enrolling patients
Purpose:
To look at the safety and effectiveness of CNTF implants on vision in participants with atrophic macular degeneration.
Study Design:
Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy


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, doubleblind, 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: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD Sponsor: Vitreous Retinal 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:
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 agerelated 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
▪ Study:
A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
Sponsor:
Quark Biotech, Inc.
Status:
Enrolling patients
Purpose:
To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection.
Study Design:
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 42
Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 um by OCT; BCVA not better than 20/200
Exclusion Criteria:
Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last six months; history of intraocular surgery other than cataract surgery or of retinal detachment in the study eye
Information:
(212) 452-6902 ▪ Study Name: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor:
Barnes Retina Institute
Status:
Enrolling patients
Purpose:
To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne
Study Design:
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Inclusion Criteria:
Treatment-naïve patients with active, subfoveal, exudative AMD; visual acuity of 20/40-20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other that CNV must be less than 50% of the total lesion size; lesion must be < 5400 μm in greatest linear dimension (GLD); lesion size < 10 DA
Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geo- graphic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment; subretinal hemorrhage > 50% of the total lesion; intraocular pressure greater than 30 mm Hg on 2 pressure- lowering medications; severe disciform scarring; advanced glaucoma; allergies to porfins or a known hypersensitivity to any component of Visudyne; porphyria, pregnancy, or lactation.
Information: bristudies@barnesretinainstitute. com
▪ Study:
TAPER: Second-line Therapy to Treat AMD for Patients Not Responding Well to Lucentis Therapy by Itself
Sponsor:
Vitreous Retina Macula Consultants of New York/QLT Inc.
Status:
Enrolling patients
Purpose:
To demonstrate that Visudyne- Lucentis-Dexamethasone triple therapy will give similar efficacy and safety results as Lucentis monotherapy
Study Design:
Randomized, Masked, Efficacy Study
Inclusion Criteria:
Patients with subfoveal CNV due to AMD who, after 2 to 6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4 to 8 weeks after the last treatment; all lesion composition types with a lesion greatest linear dimension (GLD) ≤5400 microns (approximately ≤9 disc areas [DA]); BCVA score of 25 to 73 letters (approximate Snellen equivalent of 20/40 to 20/320)
Exclusion Criteria:
Subfoveal geographic atrophy or subfoveal fibrosis in the study eye; intraocular surgery within 3 months of enrollment Information: (604) 742-1025


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: 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: 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, ≥50 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 noninvasive 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 ≥50; 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 (≥125 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 pro- tocol 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:
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, openlabel, 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 preservativefree 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 than 25 mm Hg or history suggesting glaucoma or glaucomatous visual field defects as documented by Goldmann or Humphrey perimetry taken within 6 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 past 3 months; history of or current acute ocular or periocular infection; major intraocular surgical procedure within 1 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 next 12 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 within 2 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 ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2; best corrected E-ETDRS visual acuity letter score ≥24 (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
▪ Study:
Laser-Ranibizumab- Triamcinolone for Diabetic Macular Edema (LRT for DME)
Sponsor: NEI/Genentech/Allergan
Status:
Currently enrolling
Purpose:
To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone.
Study Design:
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Number of Patients:
701
Inclusion Criteria:
Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2)
Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry; known allergy to any component of the study drug; blood pressure > 180/110 (systolic above 180 OR diastolic above 110); myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; pregnancy
Information: (866) 372-7601 x218

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
▪ 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 of 1-2e 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 of 3 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.) within 3 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 to 19 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 by 3 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 6 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 next 12 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 pregnancy, agerelated macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
Information: (617) 573-1021

COMPLETED ENROLLMENT
▪ Study:
Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate
Sponsor:
University of Iowa
Information: http://www.clinicaltrials.gov/ct/show/NC T00349739?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/NC T00211419?order=2
▪ Study: Identification and Treatment of Feeder Vessels in AMD
Sponsor: NEI Information: http://www.clinicaltrials.gov/ct/show/NC T00018070?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: Combination Bevacizumab and Verteporfin in Neovascular AMD
Sponsor: Retinal Consultants Medical Group
Information: http://www.clinicaltrials. gov/ct/show/NCT00426998?order=1
▪ Study: Evaluation and Treatment of Patients With Inherited Eye Disease
Sponsor: NEI
Information: http://www.clinicaltrials. gov/ct/show/NCT00011817?order=1 COMPLETED TRIALS
▪ Study:
Comparison of Modified Early Treatment Diabetic Retinopathy Study and Mild Macular Grid Laser Photocoagulation Strategies for DME Sponsor: Diabetic Retinopathy Clinical Research Network
Results:
Available at http://www.ncbi. nlm.nih.gov/entrez/query.fcgi?db=pubme d&cmd=Retrieve&dopt=AbstractPlus&list_uids=17420366&query_hl=2&itool=pubme d_DocSum
▪ Study: Diurnal Variation in Retinal Thickening Measurement by OCT in Center-involved DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Results:
Available at http://www.ncbi. nlm.nih.gov/entrez/ query.fcgi?db=pubmed&cmd=Retrieve&d opt=AbstractPlus&list_uids=17159029&qu ery_hl=4&itool=pubmed_docsum



Retinal Physician, Issue: May 2007