NCT00414206
Terminated
Phase 2
A Phase II Randomized, Double-Masked, Study Comparing the Safety and Efficacy of ATG003 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (NV-AMD)
CoMentis41 sites in 6 countries343 target enrollmentStarted: March 2007Last updated:
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- CoMentis
- Enrollment
- 343
- Locations
- 41
- Primary Endpoint
- Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Overview
Brief Summary
This is a Phase II randomized, double-masked study comparing the safety and efficacy of ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular ("wet") age-related macular degeneration (NV-AMD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1% mecamylamine
Active Comparator
Intervention: Mecamylamine (Drug)
0.3% mecamylamine
Active Comparator
Intervention: Mecamylamine (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline.
Time Frame: Baseline to Week 48
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (41)
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