Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF

Phase 2

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Placebo; Drug: ATG003 (mecamylamine)

• Registration Number: NCT00607750
• Lead Sponsor: CoMentis

Brief Summary

This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-02-06
• Study Start: 2008-05
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• > 55 years of age
• clinical diagnosis of neovascular AMD

Exclusion Criteria

• confounding ocular condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
ATG003	ATG003 (mecamylamine)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)	Day 1 - Week 50

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of ATG003	Day 1 - Week 50