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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414206
First Posted: December 21, 2006
Last Update Posted: November 23, 2010
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.
Information provided by:
CoMentis
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00414206


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

Additional Information:
Responsible Party: Carl Grove, CoMentis, Inc.
ClinicalTrials.gov Identifier: NCT00414206     History of Changes
Other Study ID Numbers: ATG003-201
First Submitted: December 19, 2006
First Posted: December 21, 2006
Results First Submitted: August 16, 2010
Results First Posted: November 23, 2010
Last Update Posted: November 23, 2010
Last Verified: October 2010

Keywords provided by CoMentis:
AMD
Wet AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mecamylamine
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