CLINICAL TRIAL UPDATE
DRY AMD
Study: Anecortave Acetate Risk Reduction Trial (AART)
Sponsor: Alcon Research, Ltd.
Status: Enrollment is ongoing
Purpose: Demonstrate that anecortave acetate (15 mg or 30 mg) is safe and effective in arresting the progression of nonexudative AMD in patients who are at risk for progressing to exudative AMD
Design: Phase 3, double-masked, randomized, parallel group, no-treatment (sham administration), safety/efficacy study
Inclusion/Exclusion Criteria: Patients at least 50 years of age, any race and either sex, with a clinical diagnosis of exudative AMD in the nonstudy eye, and at least 5 or more intermediate (>63 μm ) or larger soft drusen within 3000 μm of the foveal center and/or confluent drusen within 3000 μm of the foveal center, and hyperpigmentation within 3000 μm of the foveal center in the study eye.
Information: (866) 692-5959; http://www.alconlabs.com/us/eo/clinical studies
WET AMD
Study: MSI-1256F-209
Sponsor: Genaera Corporation
Status: Enrollment completed
Purpose: Evaluate the safety and efficacy of EVIZON in all subtypes of wet AMD over a 2-year period. Also, to evaluate 2 dose levels of EVIZON (20 mg or 40 mg) given once weekly for 4 weeks, followed by maintenance doses every 4 weeks until week 48
Design: Multi-centered, randomized, double-masked, controlled, phase II
Number of Patients: 120
Inclusion Criteria: 50 years of age or older. Both genders included. Patients with a diagnosis of "wet" AMD.
Exclusion Criteria: Prior treatment of AMD degeneration in the affected eye in the past 3 months.
Information: (610) 941-4020
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, MA; Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH; Jules Stein Eye Institute, UCLA, Los Angeles, CA
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 scaring <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: 50 years or older, occult or minimally classic subfoveal CNV, presence of blood associated with the lesion, vision loss or growth of lesion objectively recorded within preceding 3 months, baseline VA score between 20/40–20/400, lesion �5400 μm
Exclusion Criteria: Predominantly classic CNV, additional eye disease, CNV not involving geometric center of FAZ, inability to be photographed; fluorescein allergy; photophobia; lens opacities expected to progress during study; previous treatment for CNV, other than confluent laser photocoagulation (eg, PDT, submacular surgery, radiotherapy, macular grid); participation in another clinical trial; IOP >21 mm Hg on or off meds; prior treatment with another antiangiogenic compound within 6 months of screening; inability to comply with all study-related procedures; concomitant therapy with systemic or topical corticosteroids or NSAIDs (chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study); a low dose of ASA (up to 100 mg PO qd) taken for prophylaxis of MI and/or stroke is permitted during the study; concomitant coumadin therapy
Number of Patients: 120
Information: Namrata Saroj, (202) 605-3777
Study: Preservative-free Triamcinolone Acetonide (PFTA)
Sponsor: QLT Inc., National Eye Institute
Status: Enrolling patients
Purpose: Investigate the long-term safety and potential efficacy of PFTA in patients with wet AMD (all types) undergoing Visudyne therapy
Design: Phase 3, randomized, prospective
Number of Patients: 300
Inclusion Criteria: Age greater than or equal to 50 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 micro m; 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: Combretastatin A-4 Phosphate (CA4P) in Patients with Neovascular AMD (FBO-206)
Sponsor: OXiGENE
Status: Enrolling patients
Purpose: Assess the safety and tolerability of combretastatin administered intravenously in patients with all forms of neovascular AMD (classic and occult)
Design: Phase 1/2, open label, safety and tolerability study. The study cycle consists of a prestudy evaluation period (2–4 weeks), a 22-day treatment period, and an 8-week post-treatment evaluation period
Number of Patients: 15–20
Site(s): 1, Wilmer Eye Institute, Baltimore, Md
Inclusion/Exclusion Criteria: 50 or older, study eye BCVA of 20/40 or less, fellow eye better or equal to 20/800 ETDRS, no history of previous subfoveal thermal laser therapy
Information: (781) 547-5912
Study: ANCHOR
Sponsor: Genentech
Status: Ongoing
Purpose: Evaluate the safety and efficacy of ranibizumab (Lucentis) compared with verteporfin photodynamic therapy in preventing vision loss associated with AMD
Design: Phase 3, randomized, double-blind, active control, parallel assignment. Three treatment arms: PDT and sham injection, sham PDT and Lucentis dose A, sham PDT and Lucentis dose B
Inclusion/Exclusion Criteria: 50 or older; predominantly classic; subfoveal CNV due to AMD; study eye BCVA equal to or worse than 20/40, but no worse than 20/320; lesion eligible for PDT per labeling; no prior laser treatment involving the center of the fovea; no prior PDT; no prior experimental treatments for AMD
Number of Patients: 426
Site(s): 100
Information: (888) 662-6728
Study: MARINA
Sponsor: Genentech
Status: Ongoing
Purpose: Evaluate safety, efficacy, and tolerability of 24 monthly intravitreal injections of ranibizumab (Lucentis) in preventing vision loss in patients with AMD
Design: Phase 3, multicenter, randomized, double-masked, 3 treatment arms: sham injection, 300 μg ranibizumab, and 500 μg ranibizumab
Inclusion/Exclusion Criteria: 50 and older; subfoveal wet AMD; study eye BCVA equal to or worse than 20/40, but no worse than 20/320; active, minimally classic, or occult choroidal CNV due to AMD and not another cause; no previous subfoveal laser treatment; no previous verteporfin PDT; no previous experimental treatments for wet AMD
Number of Patients: 720
Site(s): 100
Information: (888) 662-6728
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: 55-11-3732-4130
Study: Evaluation and Tolerability of 4-dose Levels of Cand5 Administered by Single Intravitreal Injection in Patients with Wet AMD
Sponsor: Acuity Pharmaceuticals
Status: Recruiting
Purpose: Evaluate 4-dose levels of the small RNA interference therapeutic agent Cand5 in subjects with exudative AMD
Design: Open label study. One intravitreal injection; 4-dose levels
Inclusion Criteria: Male or female patients 50 years of age or older; subfoveal CNV, classic or occult; total lesion size <12 total disc areas, of which at least 50% is active CNV; subretinal hemorrhage (if any)-no more than 50% of the lesion; minimally classic or occult lesion must have hemorrhage and/or lipid and or documented loss of 3 or more lines of vision during the previous 3 months; vision 20/50 to 20/320, with better acuity in the fellow eye; IOP �22 mm Hg
Exclusion Criteria: Concomitant ocular disease, 3 or more prior PDT treatments, thermal laser within the previous 2 weeks, subfoveal scarring or atrophy, h/o abdominal aortic aneurysm, stroke within previous 12 months, diabetes or use of oral hypoglycemics or insulin, h/o peripheral vascular disease, allergy to fluorescein
Number of Patients: 12
Site(s): 2
Information: (215) 966-6191; http://www.acuitypharm.com
Study: PIER
Sponsor: Genentech
Purpose: Evaluate safety and efficacy of Lucentis in patients with wet AMD
Design: Lucentis phase 3b, randomized, double-masked, sham injection-controlled trial. Patients will be assigned to 1 of the following treatment arms: Lucentis dose A,
Lucentis dose B, sham injection
Inclusion Criteria: Men and women age 50 and older; active primary or recurrent wet AMD involving the center of the fovea ("subfoveal"); best corrected visual acuity of equal to or worse than 20/40, but no worse than 20/320 in the study eye; classic or occult forms of CNV due to AMD and not another cause
Exclusion Criteria: Previous verteporfin photodynamic therapy, external beam radiation therapy, transpupillary thermotherapy or intravitreal drug delivery in the study eye, participation in any clinical trial involving antiangiogenic drugs (ie, ranibizumab, pegaptanib, anecortave acetate, protein kinase C inhibitors, etc.) or any other clinical trial within the last month
Number of patients: 180
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; http://www.novartisophthalmics.com
Study: The Effect of Pegaptanib Sodium on Foveal Thickening in Patients with Exudative Subfoveal AMD
Sponsor: Eyetech Pharmaceuticals
Status: Recruiting
Purpose: Compare the safety of Macugen with that of sham treatment and to assess Macugen's effect on foveal thickening
Design: Phase 2 prospective, randomized, double-masked, sham-controlled, dose-ranging, multicenter trial. First 3 injections: randomization, 1:1:1, 0.3 mg/1 mg/sham; subjects in sham treatment group subsequently rerandomized to 0.3 mg or 1 mg
Inclusion Criteria: CNV with total lesion size of 12 DA or less of which at least 50% is active CNV; subretinal hemorrhage not more than 50% of total lesion size; no subfoveal scarring, atrophy, fibrosis, or blood over fovea; no more than 25% of the total lesion made up of scarring or atrophy, for minimally classic or occult lesions: �3 line vision loss during the previous 12 week and/or subretinal hemorrhage (not more than 50% of the total lesion size); VA approximately 20/40-20/320 in study eye and 20/800 or better in fellow eye; foveal thickness on OCT �300 μm; classic CVN for which PDT can be deferred for 54 weeks
Exclusion Criteria: Previous subfoveal thermal laser or PDT laser; intraocular surgery, including extrafoveal/juxtafoveal laser within the previous 3 months; h/o PPV or SB; pigment epithelial tears or rips; any other conditions that may be causing CNV, diabetic retinopathy; h/o stroke within 12 months of study entry; h/o peripheral vascular disease or severe cardiac disease; significant hematologic, renal, or hepatic disease
Information: Retina Associates of Cleveland, (216) 831-5700
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: Noncomparative Protocol for Use of Intravitreous Macugen Injections in Patients with AMD
Sponsor: Eyetech Pharmaceuticals
Status: Recruiting
Purpose: Provide Macugen to patients who have subfoveal CNV secondary to AMD and who are unable to participate in any other clinical studies of Macugen for AMD, until such time as the patient's lesion is considered to have resolved or stabilized or Macugen becomes commercially available
Design: Open label study, 0.3 mg intravitreous injection every 6 weeks
Inclusion Criteria: CNV with total lesion size of 12 DA or less of which at least 50% is active CNV; subretinal hemorrhage not more than 50% of the total lesion size; no subfoveal scarring, atrophy, or fibrosis; no more than 25% of the total lesion is scarring or atrophy; VA approximately 20/40-20/320 in the study eye; no fellow eye requirement; IOP �23 mm Hg
Exclusion Criteria: Eligibility for PDT with Visudyne (including patients for whom prior PDTs have been deemed ineffective); eligibility for any other Macugen trials, presence of other causes of CNV - myopia >8 D, ocular histoplasmosis, angioid streaks, choroidal rupture, multifocal choroiditis; h/o severe cardiac disease; MI within previous 6 months; ventricular tachyarrhythmias requiring ongoing treatment; unstable angina; stroke within previous 12 months; acute ocular or periocular infection; serious allergy to FA
Information: Retina Associates of Cleveland, (216) 831-5700
Study: PrONTO
Sponsor: Bascom Palmer Eye Institute and Genentech, Inc.
Status: Recruiting
Purpose: Determine how quickly the central retinal thickness decreases following ranibizumab (Lucentis) therapy using OCT and then, after 3 monthly doses determine the durability of the treatment response with intermittent therapy offered only if needed based on OCT findings
Design: Prospective, open-label, uncontrolled, clinical study
Inclusion Criteria: Neovascular AMD; subfoveal CNV; all lesion types; recent disease progression, central retinal thickness at least 300 microns; multiple visits required—6 visits each month for the first 3 months, then visits once a month thereafter for a total of 2 years
Information: Maria Esquiabro, (305) 326-6508; Dr. Philip Rosenfeld, (305) 326-6148
Study: Safety and Efficacy of AG-013958 in subjects with subfoveal choroidal neovascularization 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: TheraSight Ocular Brachytherapy System for Treatment of AMD
Sponsor: Theragenics Corporation
Number of Patients: 30
Status: Enrolling
Purpose: Investigate the safety, feasibility, and tolerability of the TheraSight Brachytherapy System for treatment of wet AMD
Design: A multicenter, randomized study of 3 doses of radiation (assigned 1:1:1) delivered by the TheraSight Brachytherapy System in participants with CNV secondary to AMD
Inclusion Criteria: Age 50 years or older; active primary or recurrent subfoveal CNV secondary to AMD with minimally classic or occult lesion; where an active lesion is defined, lesion <6 mm greatest linear dimension (GLD); submacular blood must comprise less than 75% of the total lesion; subretinal fibrosis must comprise less than 25% of the total lesion; study eye best-corrected vision of 20/100 or poorer measured on an ETDRS chart (<48 letters correct); fellow eye best-corrected vision that is at least 1 line better on an ETDRS chart than the best-corrected vision of the study eye; HbA1c <6%, signed informed consent
Exclusion Criteria: Prior AMD therapy treatment; presence of other eye diseases that could compromise visual acuity in the study eye; CNV due to other causes; hypertensive retinopathy, major cardiovascular or cerebrovascular event within the last year; inability to complete follow-up; allergy to fluorescein dye; previous radiation to the study eye; pregnancy at time of surgical procedure
Information: 1-877-960-1234; http://www.theragenics.com
Study Name: 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 II testing of AdPEDF and assess the biologic activity of AdPEDF.
Design: Phase I, open-label, dose-escalating study of a single intravitreal administration of AdPEDF. Part 1 of the study is complete; AdPEDF (at eight ascending dose levels) was administered to twenty-eight (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 twenty (20) additional patients with less advanced (moderate to severe) wet AMD at two 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 twelve weeks prior to Day 1; Other experimental medications within the last four 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.gemvec.com
Study Name: 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 (defined as angiographic evidence of neovascularization, associated contiguous areas of serous elevation of the RPE, elevated blocked fluorescence, and/or late staining), evidence of recent disease 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 one 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 anti-angiogenic 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
RETINAL DETACHMENT
Study: Denufosol Tetrasodium (INS37217 Ophthalmic), P2Y2 Receptor Agonist for Intravitreal Injection
Sponsor: Inspire Pharmaceuticals
Status: Enrolling patients
Purpose: Compare the safety and efficacy of INS37217 Ophthalmic to placebo as a first-line therapy in patients with rhegmatogenous retinal detachment
Design: Phase 2, double-masked, randomized, placebo-controlled, parallel-dose. Patients will be given a single intravitreal injection of drug or placebo and allows for up to 2 additional consecutive daily injections for patients who show signs of improvement following the previous injection
Inclusion Criteria: Rhegmatogenous retinal detachment (RRD) in only 1 eye; �18 years of age; no more than 3 separate breaks; all breaks must be clustered together and confined within an area that is no more than 2 clock hours in extent on the fundus; total area of all open breaks in the detached part of the retina is no greater than 1 clock hour in extent; retinal detachment is large enough that it cannot be immediately repaired with laser or cryo (eg, accumulated subretinal fluid extends at least 3 disk diameters from the edges of the break); macula on–VA 20/50 or better in both eyes, macula off–VA 20/50 nonstudy eye, plus history prior to this detachment of reading capability in the study eye
Exclusion Criteria: Nonrhegmatogenous (tractional or exudative); atrophic RPE or choroid; choroidal detachment; demarcation lines; coexisting pathology; >0.8 cup/disc ratio; prior RD repair (surgical or nonsurgical); intravitreal corticosteroid treatment within the previous 3 months; symptoms consistent with RRD for >14 days prior to screening if macula-on or h/o loss of reading vision in the study eye for more than 6 days prior to screening if macula-off; if macula-off and enrolled in study subject must be able to receive study drug injections (possibly up to 3) and be repaired or rescued all by the 10th day of the detachment. If enrolled in the study, subject must not be macula-off for >10 days; ongoing treatment with Diamox or Trusopt (dorzolamide); known sensitivity to P2Y2
Number of Patients: 160
Site(s): 25
Results Expected: Mid-2005
Information: (919) 941-9777, Ext. 245
DIABETIC MACULAR EDEMA
Study: Pegaptanib Sodium Injection (Macugen)
Sponsor: Eyetech Pharmaceuticals and Pfizer Inc.
Status: No longer enrolling patients. Study completion expected Q1 2005
Purpose: Compare the safety and efficacy of pegaptanib with placebo in patients with DME
Design: Phase 2, multicenter, randomized, placebo-control, double-masked. Patients received varying doses (0.3 mg, 1 mg, 3 mg) of drug or sham injection every 6 weeks for at least 12 weeks and then at the discretion of the investigators
Inclusion/Exclusion Criteria: Eligibility for thermal laser therapy for DME
Number of Patients: 169
Site(s): 41
Information: (212) 824-3100
Study Name: 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, including intravitreal or sub-Tenon's steroid, in the previous 6 months; h/o vitrectomy; 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: Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Recruiting
Purpose: Determine whether intravitreal triamcinolone 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: One 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 patients
Site(s): 1
Information: http://public.drcr.net/studies/ProtocolB_steroid/ProtBInfo.html
Study: Laser Photocoagulation for DME
Sponsor: Diabetic Retinopathy Clinical Research Network (DRCR.net) and National Eye Institute
Status: Recruiting
Purpose: Compare standard laser treatment with mild, macular-grid treatment that is milder in intensity, but more extensive in number of laser burns
Design: Pilot Study. One eye eligible: randomization, 1:1, standard/mild macular grid. Both eyes eligible: 1 eye randomized to 1 of the treatments, the other eye randomized to the other treatment
Inclusion/Exclusion Criteria: Age �18 years, study eye with best corrected E-ETDRS acuity >19 letters (20/400 or better), definite retinal thickening due to diabetic macular edema
Number of Patients: Approximately 200 patients
Site(s): 71
Information: http://public.drcr.net/studies/ProtocolA_laser/ProtAInfo.html
CENTRAL RETINAL VEIN OCCLUSION
Study: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide with Standard Care to Treat Macular Edema: 1 for CRVO and 1 for BRVO
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.RP
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