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

Ophthotech

Status and phase

Completed

Phase 1

Conditions

Age-related Macular Degeneration

Treatments

Drug: volociximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00782093

M200

Details and patient eligibility

About

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).

Enrollment

63 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.