CLINICAL TRIAL UPDATE
DRY AMD
Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Status: Enrolling patients as of May/June 2006
Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS type supplement by testing lower dose of zinc and eliminating beta-carotene
Design: Phase 3, randomized, prospective multicenter trial
Number of Patients: 4000
Number of Clinical Centers: 80 plus
Inclusion Criteria: Age greater than or equal to 55 years to 80 years; Eyes: bilateral large drusen (>125 um) 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 anti-oxidant OT-551 can help slow progression of atrophic "dry" AMD
Inclusion criteria: Age 50 years or older; Geographic atrophy or the dry form of AMD in both eyes; No history of neovascular or "wet form" of AMD in either eye; Have not participated in any other AMD clinical trial except using vitamins; No previous ocular surgery other than cataract surgery; Not presently receiving chemotherapy; Must be medically stable and able to complete the study; Participation requires 7 visits over approximately 2 years, with vision testing and eye exams at each visit
Information: Ruby Lerner, RN
Phone: (301) 451-3437
Fax: (301) 480-2566
E-mail: lernerru@nei.nih.gov
A Study: CNTF Implants for People with Vision Impairment Due to Atrophic AMD
Sponsor: National Eye Institute
Status: Enrolling Patients
Purpose: To investigate the effects of CNTF implants in patients with vision impairment due to atrophic AMD
Inclusion criteria: BCVA in the study eye <20/63–20/160 (58->39 letter score) as measured EVA; Presence in the study and/or fellow eye of angiographic atrophy (GA)
Exclusion Criteria: Less than 50 years of age; Medically unable to comply with study tests or follow-up visits; Evidence of ocular disease other than AMD (eg, diabetic retinopathy, central serous chorio-retinopathy, uveitis, pathologic myopia, glaucoma); Evidence of and history of treatment for CNV other than antioxidant vitamins and minerals; Previous intraocular surgery except for cataract surgery; Participation in any other clinical trial for AMD (except for vitamin therapy); Inability to obtain quality fundus photographs; History of ocular Herpes simplex virus
Information: Renee Gaiter, RN, BSN
Phone: (301) 594-9825
Fax: (301) 435-1629
E-mail: gaiter@nei.nih.gov
Study: NT-501
Sponsor: Neurotech
Status: Enrolling patients
Purpose: To evaluate the efficacy and safety of the CNTF implant
Design: Phase 2, randomized, double-masked, sham-controlled dose ranging study
Site(s): 1
Information: (212) 213-0006
WET AMD
Study: A Study to Evaluate Ranibizumab in Subjects with CNV Secondary to AMD
Sponsor: Genentech
Status: Enrolling patients
Purpose: (Primary) To estimate the incidence of ocular and non-ocular serious adverse events in subjects treated with intravitreal ranibizumab; (Secondary) To estimate the incidence of ocular and non-ocular adverse events and the proportion of subjects with a decrease from baseline in BCVA of at least 15 letters at month 12
Design: Phase 3b, single-masked multicenter, randomized
Number of Patients: 5000
Inclusion Criteria: Age >50 years; signed consent form; subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following: �5 letters of BCVA lost within 6 months preceding day 0;�10% increase in lesion area, as determined by FA performed within 1 month preceding day 0 to FA performed within 6 months preceding day 0; classic CNV comprimising >50% of CNV lesion area; BCVA using EDTRS charts for Cohort 1 and Snellen charts for Cohort 2, of 20/40-20/320 in the study eye
Exculsion Criteria: Treatment with verteporfin PDT, pegaptanib sodium, or other AMD therapy in the study eye <30 days preceding day 0; history of submacular surgery or toherr surgical intervention for AMD in study eye; previous participation in any studies of investigational drugs within 30 days preceding day 0 (excluding vitamins and minerals); prior participation in a Genentech ranubizumab clinical trial; treatment with intravitreally administered Avastin within 30 days preceding day 0; concurrent use of systemic anti-VEGF drugs; fibrosis or atrophy involving the center of the fovea in the study eye, in the absence of a new lesion; CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia; RPE tear involving the macula in the study eye; any concurrent intraocular condition, active intraocular inflammation or current VH in the study eye; history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in study eye; history of idiopathic or autoimmune-associated uveitis in either eye; active infectious keratitis, scleritis, or endophthalmitis in either eye; aphakia or pseudophakia with absence of the posterior capsule; spherical equivalent of the refractive error in study eye demonstrating within 2 months preceding day 0; uncontrolled glaucoma in study eye; concurrent use of more than 1 therapy for glaucoma; glaucoma filtering surgery or corneal transplant in study eye; history of other disease, metabolic dysfunction, physical examination finding, or clinical lab finding to contraindicate the use of an investigational drug that might affect interpretation of the results or render the subject at high risk for treatment complications; current treatment for significant active systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections; inability to comply with study or follow-up procedures
Information: (888) 662-6728
A Study: MRVT-920101-OPH005
Sponsor: Miravant Pharmaceuticals, Inc.
Status: Recruiting
Purpose: Confirm the efficacy and safety of rostaporfin (PHOTREX)
photodynamic therapy in the treatment
of classic and occult subfoveal choroidal
neovascularization
associated with AMD
Design: Multi-centered, multinational, randomized, double-masked, placebo-controlled, phase 3
Number of Patients: 660
Site(s): Multiple European Union and Non-European locations
Inclusion Criteria: Age >50 years; At least 1 subfoveal CNV membrane secondary to AMD that can be demonstrated by flourescein angiography; Best corrected VA score of 20/40–20/200
Information: (800) 685-2959
Study: SIRNA 0401
Sponsor: Sirna Therapeutics, Inc., Boulder, Colo
Status: Enrolling patients
Purpose: Assess the safety and tolerability of Sirna-027; assess the presence of Sirna-027 in plasma; determine the range of doses for the phase 2 clinical trial; and assess biological and anatomical changes in the retina
Design: Phase 1, open-label, dose-escalation -4 to 6 dose cohorts, 1 intravitreal injection
Number of Patients: 12–30
Site(s): 4–Wilmer Eye Institute, Baltimore, Md; Massachusetts Eye and Ear Infirmary, Boston, Mass; Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio, Jules Stein Eye Institute, UCLA, Los Angeles, Calif.
Inclusion/Exclusion Criteria: 50 years of age or older; subfoveal to AMD, classic and/or occult; no other causes of CNV; total lesion size 12 MPS disc area; subretinal hemorrhage <50% of lesion; subfoveal scarring <50% of lesion; lesion thickness 250 μm; IOP 25 mm Hg; visual acuity 20/100 to 20/800 ETDRS; fellow eye visual acuity not worse than 20/800 ETDRS
Information: (720) 406-2963
Study: Visudyne with Intravitreal Triamcinolone Acetonide (VisTA) Trial
Sponsor: LuEsther T. Mertz Retinal Research Center
Status: Recruiting
Purpose: Evaluate the effect of photodynamic therapy in conjunction with intravitreous triamcinolone acetonide in subjects with occult or minimally classic subfoveal CNV secondary to AMD
Design: Randomization 1:1:1, PDT and
0 mg of triamcinolone/PDT
and 1 mg of triamcinolone/PDT and 4 mg of triamcinolone
Inclusion Criteria: Age >50 years; occult or minimally classic subfoveal CNV, presence of blood associated with the lesion, vision loss or growth of lesion objectively recorded within preceding 3 months, baseline VA score between 20/40–20/400, lesion �5400 μm
Exclusion Criteria: Predominantly classic CNV, additional eye disease, CNV not involving geometric center of FAZ, inability to be photographed; fluorescein allergy; photophobia; lens opacities expected to progress during study; previous treatment for CNV, other than confluent laser photocoagulation (eg, PDT, submacular surgery, radiotherapy, macular grid); participation in another clinical trial; IOP >21 mm Hg on or off meds; prior treatment with another antiangiogenic compound within 6 months of screening; inability to comply with all study-related procedures; concomitant therapy with systemic or topical corticosteroids or NSAIDs (chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study); a low dose of ASA (up to 100 mg PO qd) taken for prophylaxis of MI and/or stroke is permitted during the study; concomitant coumadin therapy
Number of Patients: 120
Information: Namrata Saroj, (202) 605-3777
A Study: Preservative-free Triamcinolone Acetonide (PFTA)
Sponsor: QLT Inc., National Eye Institute
Status: Enrolling patients
Purpose: Investigate the long-term safety and potential efficacy of PFTA in patients with wet AMD (all types) undergoing Visudyne therapy
Design: Phase 3, randomized, prospective
Number of Patients: 300
Inclusion Criteria: Age greater than or equal to 50 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; visual acuity of 20/40 - 20/200 (73-34 letter score) as measured on an ETDRS chart; in the study eye, the presence of choroidal neovascularization under the fovea
Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; the presence of a chorio-retinal anastomosis; presence of fibrosis, hemorrhage, pigment epithelial detachments, and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
Information: (301) 496-5248
Study: Evaluation of Safety and Efficacy of Anecortave Acetate vs. Placebo in Patients with Subfoveal CNV due to Exudative AMD (C-02-29)
Sponsor: Alcon Research, Ltd.
Status: Enrollment is ongoing in South America
Purpose: Demonstrate that anecortave acetate 15 mg is superior to placebo in maintenance of visual acuity
Design: Phase 3, double-masked, randomized, parallel group, placebo-control, safety and efficacy study
Inclusion/Exclusion Criteria: Patients at least 50 years of age, any race and either sex with minimally classic and occult exudative AMD with subfoveal choroidal neovascularization
Information: (800) 757-9195
A Study: Squalamine
Sponsor: Genaera Corporation
Status: Enrolling patients
Purpose: Evaluate the safety and efficacy of intravenously administered squalamine as a first-line therapy for wet AMD
Design: Phase 2, randomized, double-masked, controlled study; 2 dose levels once weekly for 4 weeks, followed by maintenance doses once every 4 weeks through week 48. At the end of therapy, each patient will be followed for an additional year
Number of Patients: 100
Site(s): Multicenter
Information: (610) 941-4020
Study: Safety and Efficacy of AG-013958 in Subjects with Subfoveal CNV Associated with Age-related Macular Degeneration
Sponsor: Pfizer
Status: Recruiting
Purpose: Assess the safety, efficacy, and pharmacokinetics of the investigational drug AG-013958 in subjects with exudative AMD
Design: Phase 1/2, randomized, masked, single and multiple-dose, single and multiple-dose, sequential dose-escalation
Inclusion Criteria: AMD, minimally classic & occult-classic eligible in stage 2 of study (after first 46 pts), no subfoveal fibrosis; total lesion fibrosis or scar <25% total area; hemorrhage <50% of total lesion area, total lesion area �9 DA; ETDRS best corrected score of approximately 20/40-20/230; fellow eye VA �24 letters (20/320 or better); normal ECG or nonsignificant changes
Exclusion Criteria: Prior PDT
>3 months before entry; serous
pigment epithelial detachment without surrounding neovascularization; diabetic retinopathy,
glaucoma, or other serious ocular diseases or conditions; prior subfoveal photocoagulation
of the macula; prior intravitreal, sub-Tenon's, or systemic therapy for AMD; prior
TTT (transpupillary thermotherapy) or intravitreal steroids in study eye or likely
to undergo these procedures within 6 months of entry; cataract surgery within previous
12 months; intraocular surgery within previous 3 months; prior vitrectomy or submacular
surgery; prior scleral buckling, myopia �6 D; sitting BP >159/99 mm Hg on 2 out
of 3 evaluations; stroke within the previous 12 months; h/o severe cardiac disease;
peripheral vascular disease; unstable angina; MI within 6 months; ventricular tachycardia
requiring treatment; inability to stop anticoagulants 4 days prior to injection
(ASA okay to continue); participation in any clinical trials within the previous
60 days; use of systemic steroids currently or within the previous 30 days
Information: Retina Associates of Cleveland, (216) 831-5700
Study: AdGVPEDF.11D in Neovascular Age-Related Macular Degeneration (Wet AMD)
Sponsor: GenVec, Inc.
Status: Part 1 is complete; Part 2 is Enrolling Patients
Purpose: To assess the safety, tolerability and feasibility of single direct intravitreal injection of AdPEDF, identify an appropriate dose range for phase 2 testing of AdPEDF and assess the biologic activity of AdPEDF.
Design: Phase 1, open-label, dose-escalating study of a single intravitreal administration of AdPEDF. Part 1 of the study is complete; AdPEDF (at 8 ascending dose levels) was administered to 28 patients with severe wet AMD and was generally well-tolerated at all dose levels, with no dose-limiting toxicities, endophthalmitis, retinal or vitreous detachment, cataracts or glaucoma. Part 2 will treat 20 additional patients with less advanced (moderate to severe) wet AMD at 2 of the highest doses tested in part 1
Inclusion Criteria: Patients of at least
50 years in age,
with moderate to severe wet AMD (best corrected vision of 20/40 to 20/320 in the
most impaired eye), active leakage or CNV with lesion diameter less than or equal
to 5400 μm and no significant subretinal
fluid, who are not candidates for, or who have refused treatment with, subfoveal
laser photocoagulation or PDT
Exclusion Criteria: Significant retinal disease other than neovascular
AMD; Significant non-retinal disease; Cataract or other significant media opacity;
Other causes of choroidal neovascularization such as pathologic myopia (>8 D),
ocular histoplasmosis or angioid streaks; Evidence of inflammation (grade 1 or higher)
in the anterior and/or posterior chambers; Cataract surgery or submacular surgery
within
3 months; Prior ocular treatment with radiation; Known allergy to fluorescein;
Liver enzymes >2 x ULN (ALT, AST, bilirubin); Clinical evidence of active infection
of any type, including adenovirus, hepatitis A, B, or C virus or HIV virus; Other
treatment for AMD in the study eye within the last 12 weeks prior to Day 1; Other
experimental medications within the last 4 weeks prior to Day 1; Abnormal prothrombin
or partial thromboplastin time (>1.5 x ULN) or anticoagulant therapy that cannot
be withheld for treatment; Prior or current glaucoma or any atrophic change in the
fovea
Number of Patients: Up to 48
Number of Site(s): Seven (7)- Wilmer Eye Institute, Baltimore, Md, Jules Stein Eye Research Center, Los Angeles, Calif, Kresge Eye Institute, Detroit, Mich, Casey Eye Institute, Portland, Ore, University of Washington, Seattle, Wash, Cullen Eye Institute/McPherson, Houston, Texas, Florida Eye Microsurgical Institute, Inc., Boynton Beach, Fla
Information: (240) 632-5591,
rdibartolomeo@genvec.com,
www.genvec.com
Study: Interval Dose Evaluation of Anecortave Acetate (IDEAA)
Sponsor: Alcon
Status: Recruiting
Purpose: Compare anecortave acetate
15 mg administered every 3 months vs. anecortave acetate 15 mg administered every 6 months vs anecortave acetate
30 mg administered every 6 months in patients with exudative AMD
Design: Prospective, randomized 1:1:1
Inclusion Criteria: Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal CNV lesion, lesion area �12 disc areas; (30.5 mm) of any lesion type (predominantly classic, minimally classic, or occult.), choroidal neovascularization (CNV) �50% of the total lesion progression for occult lesions (defined as having experienced a loss of at least 1 line of vision or change in lesion size of more than 1 disc area [2.54 mm] or the appearance of new blood in the lesion within the past 3 months); Snellen equivalent of 20/40 to 20/200 visual acuity in the study eye (no vision criteria for the non-study eye).
Exclusion Criteria: Amblyopia, uncontrolled glaucoma with an IOP
>30 mm Hg, ischemic optic neuropathy, PDR, clinically relevant NPDR, clinically
relevant diabetic macular edema, significant active uveitis, clinical signs of myopic
retinopathy, or refraction of
>-8 D in the patient's current Rx, more than
1 PDT treatment in the study eye, extrafoveal or juxtafoveal thermal laser treatment
less than 30 days prior to enrollment, more than 2 Macugen injections in the study
eye, more than 1 triamcinolone treatment in the study eye, previous treatment with
anecortave acetate in the study eye, intraocular surgery in the study eye within
60 days prior to enrollment, scleral buckle in the study eye; Any previous systemic
antiangiogenic therapy for AMD, radiation treatment in the study eye, scleral thinning,
any unstable medical condition that would preclude ability to keep study visits,
coumadin therapy that cannot be interrupted for a 5-day period
Information: Alcon, (866) 692-5959
Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain polymorphisms predispose people to develop AMD.
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age �50 years; diagnosis
of advaced 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 dieases
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: Recruiting
Purpose: To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications; to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial; to obtain data that can be used to plan a randomized trial
Design: The study is designed as a prospective cohort study. A cohort study provides the opportunity to collect data prospectively using a standardized protocol to assess the potential benefits and risks of vitrectomy. The results can be used to determine whether proceeding with a randomized trial has merit and what the design of the trial should be. If a randomized trial is to be conducted, the results plus the cohort study experience can be used to help design the RCT protocol.
Inclusion/Exclusion Criteria: Age �18 years old, study eye with vitrectomy being performed as treatment of DME, study eye with best corrected visual acuity 20/800 or better (E-ETDRS visual acuity score �3 letters)
Information: http://public.drcr.net/studies/ProtocolD_vitrectomy/ProtDInfo.html
Study: An Observational Study of the Development of DME Following Scatter Laser Photocoagulation
Sponsor: Diabetic Retinopathy Clinical Research Network
Number of sites: 18
Number of patients: approximately 150
Status: Recruiting
Purpose: To determine the incidence and extent of macular edema following scatter laser photocoagulation surgery using optical coherence tomography (OCT) in eyes without macular edema prior to scatter laser photocoagulation, and to explore whether the incidence and extent of macular edema varies according to the number of sittings included in the treatment regimen
Design: Prospective, multi-center nonrandomized clinical trial
Inclusion/Exclusion Criteria: Age �18 years, study eye with (1) OCT center point thickness �200 μm and (2) early proliferative or severe nonproliferative diabetic retinopathy for which investigator intends to perform full scatter photocoagulation in either 1 sitting or 4 sittings
Information: http://public.drcr.net/studies/ProtocolF_prp/ProtFInfo.html
Study: Subclinical DME Study
Sponsor: Diabetic Retinopathy Clinical Research Network
Number of sites: 18
Number of patients: Approximately 1,000 patients will be enrolled in order to follow 220 patients
Status: Recruiting
Purpose: To determine how often study participants' eyes with subclinical DME (defined as no edema involving the center of the fovea as determined by biomicroscopy but with center point thickness on OCT of at least 200 μm but less than or equal to 299 μm) progress over a 2-year period to edema on OCT of at least 300 μm (which is almost always clinically apparent) and increase at least 50 μm from baseline or are treated for DME among individuals with more than minimal retinopathy (greater than level 20), and to determine mean OCT retinal thickness measurements and confidence intervals in subjects with diabetes and no or minimal non-proliferative diabetic retinopathy (level 20 or less)
Design: Prospective, multi-center observational study. The study consists of a baseline phase and follow-up phase
Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected E-ETDRS acuity �74 letters (20/32 or better).
Information: http://public.drcr.net/studies/ProtocolG_subclinical/ProtGInfo.html
Study: FAME (Fluocinolone Acetonide in Macular Edema)
Sponsor: Alimera Sciences & Controlled Delivery Systems
Number of Sites: Approximately 100
Number of Patients: over 900
Status: Phase 3 initiated
Purpose: To evaluate the safety and efficacy of sustained-release fluocinolone acetonide, at 2 doses, delivered via the Medidur intraocular sustained delivery system
Design: Double-masked, randomized, multi-center, parallel group, controlled study
Inclusion/exclusion Criteria: Patients diagnosed with DME, who
have
previously had laser treatment
Information: www.alimerasciences.com
Study: Reduction in the Occurrence of Center-threatening DME
Sponsor: Eli Lilly and Company
Status: Recruiting
Purpose: Determine whether ruboxistaurin can slow the progression of DME
Design: Randomization 1:1, ruboxistaurin/ placebo
Inclusion Criteria: Macular edema: if �1/6 DA up to <1 DA, location must be >500 μm � £ 3000 μm from center of macula or if �1 DA location must be >1500 μm � £ 3000 μm from center of macula, ETDRS retinopathy level of �20 and £ 47D in the study eye, best refracted visual acuity in the study eye of 20/32 or better
Exclusion Criteria: H/O any focal, grid, or scatter laser for
DME in the study eye; retinal artery/vein occlusions, macular degeneration, chorioretinal
scars; any intraocular surgery, including YAG laser, within the previous 6 months;
preretinal or vitreous hemorrhage (currently); treatment for DME with any
therapy;
poorly controlled DM (HA1c >11%), hypertension greater than 170 systolic;
chronic renal failure on dialysis; s/p renal transplant or creatinine >4.0; treatment
with or planned treatment with topical or oral carbonic anhydrase inhibitors; participation
in previous Lilly ruboxistaurin study
Information: Retina Associates of Cleveland
(216) 831-5700
Study: IVTA and Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Recruiting
Sites: 98
Purpose: Determine whether IVTA at doses of 1 mg or 4 mg provides greater benefit, with an acceptable safety profile, than macular laser in the treatment of DME
Design: 1 eye eligible: randomization, 1:1:1, laser/1 mg triamcinolone/4
mg triamcinolone. Both eyes eligible: 1 eye randomized to laser, the other to 1
mg or
4 mg of triamcinolone
Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected E-ETDRS acuity >24 letters (20/320 or better) and <68 letters (worse than 20/40), study eye with center-involved DME present on clinical exam and on OCT, mean retinal thickness on 2 OCT measurements >250 μm in the central subfield, fellow eye either eligible or has acuity >19 letters (20/400 or better) has not been previously treated with intravitreal corticosteroids
Number of Patients: 795
Site(s): 98
Information: http://public.drcr.net/studies/ProtocolB_steroid/ProtBInfo.html
MYOPIC MACULAR DEGENERATION
Study: Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects with Pathologic Myopia
Sponsor: OXiGENE, Inc.
Status: Enrolling
Purpose: Myopic Macular Degeneration (MMD) is a progressive eye disease caused by the thinning of the retina and underlying support tissue as the eye is stretched and elongated. This condition can result in tears in the tissues under the center of vision (macula) and bleeding can occur, which may lead to vision loss. The purpose of this study is to evaluate the safety and dose response of Combretastatin A4 Phosphate (CA4P), an investigational drug, in patients with active choroidal neovascularization secondary to myopic macular degeneration
Design: This phase 2 clinical trial is an open label, dose-ranging, international multicentered study. Drug is administered intravenously
Number of Patients: 36
Sites: 15
Inclusion Criteria: 18–50 years of age, patients must have pathologic myopia presenting refractive error of -6 D or more correction required OR an axial length of the eye >26.5 mm, area of choroidal neovascularization within 50 μm or under the geometric center of the foveal-avascular zone, BCVA in the study eye of 20/20 to 20/200, inclusive in the qualifying eye (by ETDRS measurement)
Exclusion Criteria: Patients must not be currently pregnant, planning a pregnancy, patients must not have received any previous experimental procedure in either eye or have used any investigational drug or treatment within 30 days prior to enrolling in this trial
Information: www.oxigene.com www.oxigene.com
Study: Macugen in Diabetic Macular Edema and Diabetic Retinopathy
Sponsor: (OSI) Eyetech
Status: Enrolling
Purpose: To compare the safety and efficacy of Macugen in patients with DME
Design: Phase 3, randomized, controlled, double-masked, multi-center, comparative, dose finding
Number of Patients: Planned enrollment is 900
Site(s): 41
Information: 212-824-3100
CENTRAL RETINAL VEIN OCCLUSION
Study: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Sponsor: National Eye Institute, National Institutes of Health, Department of Health and Human Services
Status: Enrollment began in October 2004
Purpose: To compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with CRVO and BRVO
Design: Multicenter, randomized, phase 3 trial. Eligible patients within each of these 2 disease entities are randomized in a 1:1:1 ratio to 1 of 3 groups: standard care, intravitreal injection(s) of 4 mg of triamcinolone acetonide, or intravitreal injection(s) of 1 mg of triamcinolone acetonide. Enrolled patients are followed for 3 years. The preparation of triamcinolone acetonide used in the study is specially made for injection into the eye and does not contain any preservatives
Inclusion/Exclusion Criteria: Participants with macular edema associated with CRVO and BRVO who are 18 years of age or older and are willing to provide consent. Detailed Inclusion/Exclusion Criteria are available on the SCORE Web site at http://spitfire.emmes.com/study/score
Number of Patients: 1260; 630 with CRVO and 630 with BRVO
Site(s): 27
Information: (301) 251-1161
COMPLETED TRIALS
WET AMD
Study: MSI-1256F-209
Sponsor: Genaera Corporation
Number of Patients: 40
Sites: 1
Information: (610) 941-4020
Results: Available at www.genaera.com/pressreleases/2003_Oct7.html
Study: Combretastatin A-4 Phosphate (CA4P) in Patients with Neovascular AMD (FBO-206)
Sponsor: OXiGENE
Number of Patients: 15–20
Site(s): 1, Wilmer Eye Institute, Baltimore, Md
Information: (781) 547-5912
Results: Available at www.oxigene.com
Study: ANCHOR
Sponsor: Genentech
Number of Patients: 423
Site(s): 100
Information: (888) 662-6728
Results: 1-year results available at: www.gene.com
Study: MARINA
Sponsor: Genentech
Number of Patients: 716
Site(s): 100
Information: (888) 662-6728
Results: Available at: www.gene.com
Study: Evaluation and Tolerability of 4-dose Levels of Cand5 Administered by Single Intravitreal Injection in Patients with Wet AMD
Sponsor: Acuity Pharmaceuticals
Number of Patients: 15
Site(s): 2
Information: (215) 966-6191
Results: www.acuitypharm.com
Study: PIER
Sponsor: Genentech
Number of patients: 184
Site(s): 3
Information: For inquiries about clinical trials, please submit a request through our information request form or call (888) 662-6728. For international inquiries, contact our international collaborator, Novartis Ophthalmics, at (866) 393-6336;
Results: Available at: www.gene.com
DIABETIC MACULAR EDEMA
A Study: EOP-1005
Sponsor: Eyetech Pharmaceuticals and Pfizer Inc.
Number of Patients: 169 (included in safety population); 172 (randomized)
Site(s): 41
Information: (212) 824-3100
Results: Published in the October issue of Ophthalmology
A Study: Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network (DRCR.net)
Number of Patients: 263
Site(s): 78
Information: http://public.drcr.net/studies/ProtocolA_laser/ProtAInfo.html
Results: Not currently
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