Article Date: 8/1/2004

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

 



Retinal Physician, Issue: August 2004