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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00782093

Enrollment

Registered

2008-10-31

Start date

2008-10-31

Completion date

2012-06-30

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

AMD

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).

Interventions

DRUGvolociximab

volociximab intravitreal injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The primary safety endpoint is the presence of any dose limiting toxicity (DLT)	2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026