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
  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:


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
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 ClinicalTrials.gov identifier: NCT00414206

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

Additional Information:
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
Eye Diseases
Retinal Degeneration
Retinal Diseases
Mecamylamine
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Cholinergic Agents
Cholinergic Antagonists
Ganglionic Blockers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014