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

NCT ID: NCT00782093

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-06-30

Brief 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).

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

volociximab

volociximab intravitreal injection

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophthotech Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

M200

Identifier Type: -

Identifier Source: org_study_id