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CompletedNCT00782093Updated Feb 21, 2024

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

A Phase 1 interventional study of volociximab in Age-related Macular Degeneration, sponsored by Ophthotech Corporation. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-02-21.

Sponsored by Ophthotech Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Age-related Macular Degeneration

Keywords

  • AMD
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 63 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Ophthotech Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Interventions

  • Drugvolociximab

    volociximab intravitreal injection

06

What researchers measure

Primary outcomes

  1. The primary safety endpoint is the presence of any dose limiting toxicity (DLT)

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00782093
Lead sponsor
Ophthotech Corporation
Responsible party
Sponsor
First posted
Oct 31, 2008
Start date
Oct 2008
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Feb 21, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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