Status:
COMPLETED
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Neovascular Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Detailed Description
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this stud...
Eligibility Criteria
Inclusion
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
Exclusion
- No prior treatment with the following in the study eye:
- Subfoveal thermal laser therapy;
- Submacular surgery or other surgical intervention for the treatment of AMD;
- Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
- PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
- Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
- Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
- Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
- Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \[YAG\] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00383370
Start Date
October 1 2006
End Date
July 1 2008
Last Update
April 21 2011
Active Locations (6)
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1
Fort Myers, Florida, United States, 33907
2
Wichita, Kansas, United States, 67214
3
Hagerstown, Maryland, United States, 21740
4
Columbia, South Carolina, United States, 29169