Article Date: 3/1/2007

Untitled Document

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; 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

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:
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:
Infliximab, Sirolimus, and Declizumab to Treat AMD
Sponsor:
National Eye Institute
Status:

Enrolling patients
Purpose:

To examine whether antiinflammatory 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:
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:
Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD
Sponsor:

Vitreoretinal Macula Consultants of New York; Genentech
Status:

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

Treatment, nonrandomized, open-label, active control, parallel assignment, safety/efficacy study
Number of Patients:
15
Inclusion Criteria:
BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone area of the CNV must occupy at least 50% of the total lesion; lesion must be ≤4000 μm in greatest linear dimension (GLD)
Exclusion Criteria:
History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to other causes than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids.
Contact:

(212) 452-6902

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

Bay Area Retinal Associates/QLT Inc.
Status:

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

Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study Number of Patients: 60
Inclusion Criteria:

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

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

(925) 943-6800

Study:
Intravitreal Injections of a Small Interfering RNA in Patients With Age- Related Macular Degeneration
Sponsor:
Allergan
Status:

Current enrolling
Purpose:

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

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 135
Inclusion Criteria:

Age of 50 or older; diagnosis of wet AMD; 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; coronary artery disease; cataracts
Contact:

clinicaltrials@allergan.com

Study:
Genetic Study of Age-Related Macular Degeneration
Sponsor:

National Eye Institute
Status:

Enrolling patients
Purpose:
To examine skin and blood cells for genetic changes related to the development of age-related macular degeneration Design: Observatinal, Natural History
Number of Patients:
150
Inclusion Criteria:
Diagnosis of AMD defined by the presence of at least 1 druse greater than 125 μm in diameter or geographic atrophy in at least 1 eye or choroidal neovascularization with drusen of any size in at least 1 eye and/or disciform scar; age 50 years or older. For control patients: absence of drusen or no more than 5 drusen less than 63 microns, absence of other diagnostic criteria for AMD, and age 50 years or older
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 which have been present prior to the age of 50; opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate stereofundus photography; medical problems which make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, terminal carcinoma); inability or inaccessibility to obtain dermal biopsy from the inner aspect of both arms due to previous trauma, underlying skin disorder which would preclude good wound healing, previous surgery of the arm or breast which could prevent good wound healing or induce other changes at the biopsy site
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

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_

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 300
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, 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

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 six months of the study; history of Cataract Surgery within 6 months of enrollment; history of YAG capsulotomy within 2 months of the surgery; visual acuity <20/400 in the fellow eye; uncontrolled glaucoma
Information:

(805) 963-1648 x26

OTHER
Study:
Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration
Sponsor:
Ophthalmic Consultants of Boston/Genentech
Status:
Currently enrolling
Purpose:
To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular- degeneration
Study Design:

Treatment, Randomized, Single Blind, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients:
30
Inclusion Criteria:
Active CNV
Exclusion Criteria:
pregnancy,agerelated macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
Information:
(617) 573-1021

COMPLETED ENROLLMENT
Study:
Age-Related Macular Degeneration and Cataract
Sponsor:
NEI
Information:

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

Study:
A Study of MSI-1256F (Squalamine Lactate) to Treat “Wet” Age-Related Macular Degeneration
Sponsor:
Genaera
Information:
http://www.clinicaltrials. gov/ct/show/NCT00333476?order=43

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

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

Study:
Lutein/Zeaxanthin and Omega- 3 Supplementation in Persons Over Age 60
Sponsor:
NEI
Information:
http://clinicalstudies.info. nih.gov/detail/B_2005-EI-0073.html

Study:
A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor (CNTF) in Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration
Sponsor:
NEI
Information:
http://clinicalstudies.info. nih.gov/detail/B_2006-EI-0071.html

Study:
Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema
Sponsor:
NEI
Information:
http://clinicalstudies.info. nih.gov/detail/B_2003-EI-0291.html

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

Study:
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Sponsor:
NEI
Results:
Available at http://www.nei.nih.gov/neitrials/view StudyWeb.aspx?id=70

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

Genentech
Results:

Available at: http://clinicalstudy results.gene.com/fvf3192g.pdf

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

Genentech
Results:
Available at http://clinical studyresults.gene.com/fvf2598g.pdf

Study:
Central Vein Occlusion Study (CVOS)
Sponsor:
NEI
Results:
Available at http://www.nei.nih. gov/neitrials/viewStudyWeb.aspx?id=30

Study:
Branch Vein Occlusion Study
Sponsor:
NEI
Results:
Available at http://www.nei.nih. gov/neitrials/viewStudyWeb.aspx?id=64



Retinal Physician, Issue: March 2007