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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:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00414206
First received: December 19, 2006
Last updated: October 26, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414206

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Carl Grove, CoMentis, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health

Keywords provided by CoMentis:
AMD
Wet AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mecamylamine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 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

ClinicalTrials.gov processed this record on June 17, 2013