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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414206
Recruitment Status : Terminated (Sponsor decision)
First Posted : December 21, 2006
Results First Posted : November 23, 2010
Last Update Posted : November 23, 2010
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Mecamylamine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
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)
Study Start Date : March 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1% mecamylamine Drug: Mecamylamine
Active Comparator: 0.3% mecamylamine Drug: Mecamylamine
Placebo Comparator: Placebo Drug: Placebo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414206

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Sponsors and Collaborators
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Study Director: Carl Grove CoMentis

Additional Information:
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Responsible Party: Carl Grove, CoMentis, Inc. Identifier: NCT00414206    
Other Study ID Numbers: ATG003-201
First Posted: December 21, 2006    Key Record Dates
Results First Posted: November 23, 2010
Last Update Posted: November 23, 2010
Last Verified: October 2010
Keywords provided by CoMentis:
Additional relevant MeSH terms:
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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