Clinical Trial Update
DRY AMD
Study: An evaluation of efficacy and safety of posterior juxtascleral administrations of anecortave acetate for depot suspension (15 mg or 30 mg) versus sham administration in patients (enrolled in Study "A" or Study "B") at risk for developing sight-threatening CNV due to exudative AMD (C-02-60)
Sponsor: Alcon Research, Ltd.
Status: Enrollment is ongoing
Purpose: To 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 III, 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 microns) or larger soft drusen within 3000 microns of the foveal center and/or confluent drusen within 3000 microns of the foveal center, and hyperpigmentation within 3000 microns of the foveal center in the study eye.
Information: (866) 692-5959, www.alconlabs.com/us/eo/clinicalstudies
WET AMD
Study: Preservative-free triamcinolone acetonide (PFTA) in patients with wet AMD
Sponsor: QLT Inc., National Eye Institute
Status: Enrolling patients
Purpose: To investigate the long-term safety and potential efficacy of PFTA in wet AMD (all types) patients undergoing Visudyne therapy
Design: Phase III, randomized, prospective
Number of Patients: 300
Site(s): Multicenter
Information: (301) 496-5248
Study: Open label, pilot, dose-escalation safety and tolerabilty study of combretastatin A-4 phosphate (CA4P) in patients with neovascular age-related macular degeneration (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 I/II, open label; the study cycle consists of a pre-study 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): 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 (randomized, double-masked, active treatment-controlled study of the efficacy and safety of rhuFAb V2 compared with verteporfin in subjects with predominantly classic subfoveal neovascular AMD)
Sponsor: Genentech
Status: Ongoing
Purpose: Evaluate the safety and efficacy of ranibizumab (Lucentis) compared with verteporfin photodynamic therapy in preventing vision loss associated with age-related macular degeneration.
Design: Phase III, 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
Number of Patients: 426
Number of Sites: 100
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 fro AMD.
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 III, multicenter, randomized, double-masked; three treatment arms: sham injection, 300 micrograms ranibizumab , 500 micrograms ranibizumab
Number of Patients: 720
Site(s): 100
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
Information: (888) 662-6728
Study: An evaluation of safety and efficacy of anecortave acetate versus 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: To demonstrate that anecortave acetate 15 mg is superior to placebo in maintenance of visual acuity
Design: Phase III, double-masked, randomized, parallel group, placebo-control, safety/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: Phone: 55-11-3732-4130
Study: An evaluation of efficacy and safety of posterior juxtascleral injections of anecortave acetate 15 mg (0.5 ml of 30 mg/ml anecortave acetate sterile suspension) versus Visudyne in patients with subfoveal exudative AMD eligible for initial treatment with photodynamic therapy using Visudyne (C-01-99)
Sponsor: Alcon Research, Ltd.
Status: Enrollment is complete; study is ongoing
Purpose: To demonstrate that anecortave acetate 15 mg is equal to or better than PDT with Visudyne after 12 months of treatment in patients eligible for initial PDT treatment
Design: Phase III, double-masked, randomized, parallel group, active-control, safety/efficacy study
Inclusion/Exclusion Criteria: Patients at least 50 years of age, any race and either sex with exudative AMD who qualified for PDT treatment with Visudyne
Study: An open-label evaluation of long-term efficacy and safety of posterior juxtascleral injections of anecortave acetate 15 mg in patients with subfoveal exudative AMD who were enrolled in Alcon study C-98-03
Sponsor: Alcon Research, Ltd.
Status: Enrollment is complete
Purpose: To demonstrate that anecortave acetate 15 mg is superior to placebo in maintenance of visual acuity
Design: Phase III, nonrandomized, open-label, uncontrolled, single group, safety/efficacy study
Inclusion/Exclusion Criteria: Patients with subfoveal exudative AMD who were enrolled in Alcon study C-98-03
Study: An evaluation of safety and efficacy of anecortave acetate versus placebo in patients with subfoveal CNV due to exudative AMD (C-02-27)
Sponsor: Alcon Research, Ltd.
Status: Enrollment is ongoing in Europe and New Zealand
Purpose: To demonstrate that anecortave acetate 15 mg is superior to placebo in maintenance of visual acuity
Design: Phase III, double-masked, randomized, parallel group, placebo-control, safety/efficacy study
Inclusion/Exclusion Criteria: Patients at least 50 years of age, any race and either sex with minimally classic and occult exudative age-related macular degeneration with subfoveal CNV
Information: 34-93-497-7018
Study: VEGF inhibition in ocular neovascularization (VISION) (Macugen)
Sponsor: Eyetech Pharmaceuticals and Pfizer Inc.
Status: No longer enrolling patients. New Drug Application filed with FDA in June. Fast Track designation. Dermatologic and Ophthalmic Drugs Advisory Committee review on August 27.
Purpose: To establish the safety and efficacy of intravitreal injections of pegaptanib sodium in patients with exudative AMD.
Design: 2 phase II/III trials: randomized, double-masked, controlled, dose-ranging; any subtype of CNV, visual acuity 20/40 to 20/320, and lesion size of 12 disc areas or less; subjects randomly assigned to 0.3 mg, 1 mg, or 3 mg of pegaptanib sodium or to sham treatment. Treatment given every 6 weeks, for a usual total of 9 treatments; subjects followed for 54 weeks; PDT allowed for predominantly classic lesions, at the investigator's discretion
Number of Patients: 1186
Site(s): 117
Inclusion/Exclusion Criteria: Any subtype of CNV; visual acuity 20/40 to 20/320; lesion size 12 disc areas or less.
Publication: Study Group report submitted to the New England Journal of Medicine
Information: (212) 824-3100
Study: tin ethyl etiopurpurin photodynamic therapy (SnET2-PDT)
Sponsor: Miravant Medical Technologies
Status: New Drug Application submitted to FDA on March 31. Priority Review designation.
Purpose: To determine the safety and efficacy of SnET2 in patients with subfoveal CNV secondary to AMD
Design: 2 phase III randomized, double-masked, placebo-controlled, parallel group studies. Patients were given an initial single treatment of PhotoPoint SnET2 or placebo followed by a low power light treatment. Patients followed for 2 years and re-treated if required.
Number of Patients: 920
Site(s): 60
Inclusion/Exclusion Criteria: Total lesion size equal to or less than 3,000 microns in greatest diameter; visual acuity of 15 or more ETDRS letters; all lesion subtypes.
Information: (805) 685-9880
Study: Squalamine
Sponsor: Genaera Corp.
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of intravenously administered squalamine as a first-line therapy for wet AMD; to evaluate two dose levels
Design: Phase II, randomized, double-masked, controlled study; two 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
RETINAL DETACHMENT
Study: denufosol tetrasodium (INS37217 Ophthalmic), P2Y2 receptor agonist for intravitreal injection
Sponsor: Inspire Pharmaceuticals
Status: Enrolling patients
Purpose: To compare the safety and efficacy of INS37217 Ophthalmic to placebo as a first-line therapy in patients with rhegmatogenous retinal detachment
Design: Phase II double-masked, randomized, placebo-controlled parallel-dose. Patients will be given a single intravitreal injection of drug or placebo and allows for up to two additional consecutive daily injections for patients who show signs of improvement following the previous injection
Number of Patients: 160
Site(s): 25
Results Expected: Mid-2005
Information: (919) 941-9777, Ext. 245
VITREOUS HEMORRHAGE
Study: Ovine hyaluronidase (Vitrase)
Sponsor: ISTA Pharmaceuticals
Status: Completed; preliminary results March 2002; FDA approvable letter April 2003
Purpose: To evaluate efficacy in clearing hemorrhage
Design: 2 Phase III studies: prospective, randomized, parallel, placebo-controlled, double-masked; patients assigned to control group (saline injection) or test group (7.5 IU, 55 IU international unit, or 75 IU international unit injection of Vitase)
Number of Patients: 750, 556
Site(s): Multiple, U.S. and international
Inclusion/Exclusion Criteria: Vitreous hemorrhage present for at least 1 month; BCVA of less than 20/200 at initial screening
Information: (949) 788-6000
DIABETIC RETINOPATHY
Study: Ovine hyaluronidase (Vitrase)
Sponsor: ISTA Pharmaceuticals
Status: Completed
Purpose: To evaluate the safety and efficacy of single-dose injection to cause a detachment of the vitreous humor from the retina and the impact on slowing the progression of diabetic retinopathy over a 1-year period
Design: Pilot phase II
Number of Patients: 60
Information: (949) 788-6000
CENTRAL RETINAL VEIN OCCLUSION
Study: Pegaptanib sodium (Macugen)
Sponsor: Eyetech Pharmaceuticals, Pfizer
Status: Recruiting patients
Purpose: To compare the safety and efficacy of Macugen injection to sham injection for 30 weeks in patients with recent vision loss due to macular edema secondary to CRVO; pharmacokinetics
Design: Phase II, randomized, double-blind, placebo-control, parallel assignment
Number of Patients: 90
Site(s): Jules Stein Eye Institute, Los Angeles, Calif.
Inclusion/Exclusion Criteria: CRVO occurring within past 6 month and associated with macular edema determined by OCT; vision in study eye 20/50 to 20/400; vision in fellow eye 20/200 or better; no signs of previous CRVO or BRVO in study eye; no prior PRP or scatter photocoagulation; no prior corticosteroids for ophthalmic conditions; no history of retinal detachment
Information: (866) 622-8436
DIABETIC MACULAR EDEMA
Study: pegaptanib sodium injection (Macugen)
Sponsor: Eyetech Pharmaceuticals and Pfizer Inc.
Status: ongoing
Purpose: To compare the safety and efficacy of pegaptanib with placebo in patients with diabetic macular edema
Design: Phase II, multicenter, randomized, placebo-controlled, 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.
Number of Patients: 169
Inclusion/Exclusion Criteria: Eligibility for thermal laser therapy for DME
Study: fluocinolone acetonide implant (Retisert)
Sponsor: Control Delivery Systems and Bausch & Lomb Pharmaceuticals
Status: No longer enrolling patients; 12-month data released May 2003; regulatory filing delayed for up to 2 years
Purpose: To assess the safety and efficacy of the Retisert implant for the treatment |of DME
Design: Phase III, randomized, controlled, masked; patients randomized to receive standard of care (macular grid laser or observation) or either a 0.5 mg or a 2 mg Retisert implant; enrollment of patients for the 2 mg dose discontinued early on
Number of Patients: 80
Site(s): Multicenter
MACULAR EDEMA
Study: dexamethasone implant (Posurdex)
Sponsor: Allergan
Status: Ongoing
Purpose: To test the safety and efficacy of the dexamethasone implant
Design: Phase II controlled, prospective, randomized; three treatment arms: implant containing 350-gram dose, implant containing 700-g dose, observation
Number of Patients: 306
Site(s): Multicenter
Inclusion/Exclusion Criteria: Macular edema associated with diabetes, retinal vein occlusion, uveitis or post-cataract surgery
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