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

• Sponsor: CoMentis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00607750
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Drug: ATG003 (mecamylamine); Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Placebo; Placebo eyedrops, BID, 48 weeks
Experimental: ATG003	Drug: ATG003 (mecamylamine); 1% Ophthalmic solution, eyedrop BID, 48 weeks

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) [Day 1 - Week 50]

Secondary Outcome Measures

1. To evaluate the efficacy of ATG003 [Day 1 - Week 50]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 55 years of age

• clinical diagnosis of neovascular AMD

Exclusion Criteria:

• confounding ocular condition

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• CoMentis

Investigators

• Study Director: Carl Grove, MS, Comentis, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00607750
• Other Study ID Numbers: ATG003-203
• First Posted: Feb 6, 2008
• Last Update Posted: Oct 28, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Wet AMD, Comentis, ATG003, mecamylamine
• Additional relevant MeSH terms: Macular Degeneration; Mecamylamine

Study Results

No Results Posted as of Oct 28, 2010