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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.
ClinicalTrials.gov Identifier: NCT00414206
Recruitment Status : Terminated (Sponsor decision)
First Posted : December 21, 2006
Results First Posted : November 23, 2010
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
CoMentis

December 19, 2006
December 21, 2006
August 16, 2010
November 23, 2010
November 23, 2010
March 2007
June 2009   (Final data collection date for primary outcome measure)
Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. [ Time Frame: Baseline to Week 48 ]
ETDRS
Complete list of historical versions of study NCT00414206 on ClinicalTrials.gov Archive Site
Not Provided
OCT, FA
Not Provided
Not Provided
 
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
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)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Macular Degeneration
  • Drug: Mecamylamine
  • Drug: Placebo
  • Active Comparator: 1% mecamylamine
    Intervention: Drug: Mecamylamine
  • Active Comparator: 0.3% mecamylamine
    Intervention: Drug: Mecamylamine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
343
330
September 2009
June 2009   (Final data collection date for primary outcome measure)
Not Provided
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Czech Republic,   Mexico,   Poland,   Russian Federation,   Ukraine
 
 
NCT00414206
ATG003-201
Yes
Not Provided
Not Provided
Carl Grove, CoMentis, Inc.
CoMentis
Not Provided
Study Director: Carl Grove CoMentis
CoMentis
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP