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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT00782093
First received: October 29, 2008
Last updated: October 11, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Age-related Macular Degeneration
Drug: volociximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:
  • The primary safety endpoint is the presence of any dose limiting toxicity (DLT) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: October 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: volociximab
    volociximab intravitreal injection
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ophthotech Corporation
ClinicalTrials.gov Identifier: NCT00782093     History of Changes
Other Study ID Numbers: M200
Study First Received: October 29, 2008
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ophthotech Corporation:
AMD

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014