Status:
COMPLETED
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated in...
Detailed Description
This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a ser...
Eligibility Criteria
Inclusion
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
- Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.
Exclusion
- History of any vitreous hemorrhage within 4 weeks prior to Day 1.
- Aphakia.
- Significant subfoveal atrophy or scarring.
- 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.
- Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
- Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
- Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
- Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
- Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
- Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00320788
Start Date
April 1 2006
End Date
August 1 2008
Last Update
March 1 2012
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
2
Retina Centers, PC
Tucson, Arizona, United States, 85704
3
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
4
Loma Linda University Health Care
Loma Linda, California, United States, 92354