A Phase 1 Ascending and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age- Related Macular Degeneration

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ophthotech Corporation
• Treatments: Antibodies, Monoclonal; Volociximab

Criteria

Inclusion Criteria:

• Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram.

Exclusion Criteria:

• Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals.

• Previous or concomitant therapy with intravitreous corticosteroids.

• Any of the following underlying diseases including:

• Diabetic retinopathy

• History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.

• History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.

• Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech.

• Stroke (within 12 months of trial entry).

• Any major surgical procedure within one month of trial entry.

• Previous therapeutic radiation in the region of the study eye.

• Any treatment with an investigational agent in the past 60 days for any condition.

• Women who are pregnant or nursing.

• Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the volociximab formulation.