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:
Ophthotech Corporation
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
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
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More Information
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| 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 Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 13, 2013