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Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)

This study has been terminated.
(Sponsor decision)
Information provided by:
CoMentis Identifier:
First received: December 19, 2006
Last updated: October 26, 2010
Last verified: October 2010
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).

Condition Intervention Phase
Macular Degeneration Drug: Mecamylamine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by CoMentis:

Primary Outcome Measures:
  • Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. [ Time Frame: Baseline to Week 48 ]

Enrollment: 343
Study Start Date: March 2007
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1% mecamylamine Drug: Mecamylamine
Active Comparator: 0.3% mecamylamine Drug: Mecamylamine
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00414206

  Show 42 Study Locations
Sponsors and Collaborators
Study Director: Carl Grove CoMentis
  More Information

Additional Information:
Responsible Party: Carl Grove, CoMentis, Inc. Identifier: NCT00414206     History of Changes
Other Study ID Numbers: ATG003-201
Study First Received: December 19, 2006
Results First Received: August 16, 2010
Last Updated: October 26, 2010

Keywords provided by CoMentis:

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017