A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
| Status: | Archived |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2010 |
| End Date: | March 2012 |
A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration
The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous
injection when administered in combination with Lucentis® against a control of Lucentis®
alone in subjects with subfoveal choroidal neovascularization secondary to age-related
macular degeneration (AMD).
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 sham + Lucentis® 0. 5 mg/eye
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at
Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is the proportion of subjects gaining at least 15 letters
between baseline and the Week 12 visit.
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity,
intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein
angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.
Approximately 444 subjects will be randomized into one of the three treatment cohorts
(approximately 148 patients per dose group).
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