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

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: NCT00607750
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
CoMentis

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE May 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) [ Time Frame: Day 1 - Week 50 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
To evaluate the efficacy of ATG003 [ Time Frame: Day 1 - Week 50 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: ATG003 (mecamylamine)
    1% Ophthalmic solution, eyedrop BID, 48 weeks
  • Drug: Placebo
    Placebo eyedrops, BID, 48 weeks
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: ATG003
    Intervention: Drug: ATG003 (mecamylamine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • confounding ocular condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 56 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00607750
Other Study ID Numbers  ICMJE ATG003-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carl Grove, President, CoMentis, Inc.
Study Sponsor  ICMJE CoMentis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl Grove, MS Comentis, Inc.
PRS Account CoMentis
Verification Date October 2010

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