Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF

This study has been completed.
Sponsor:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00607750
First received: January 23, 2008
Last updated: October 26, 2010
Last verified: October 2010

January 23, 2008
October 26, 2010
May 2008
April 2010   (final data collection date for primary outcome measure)
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) [ Time Frame: Day 1 - Week 50 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00607750 on ClinicalTrials.gov Archive Site
To evaluate the efficacy of ATG003 [ Time Frame: Day 1 - Week 50 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)

This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related Macular Degeneration
  • Drug: ATG003 (mecamylamine)
    1% Ophthalmic solution, eyedrop BID, 48 weeks
  • Drug: Placebo
    Placebo eyedrops, BID, 48 weeks
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: ATG003
    Intervention: Drug: ATG003 (mecamylamine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 55 years of age
  • clinical diagnosis of neovascular AMD

Exclusion Criteria:

  • confounding ocular condition
Both
56 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00607750
ATG003-203
No
Carl Grove, President, CoMentis, Inc.
CoMentis
Not Provided
Study Director: Carl Grove, MS Comentis, Inc.
CoMentis
October 2010

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