Back to resultsSafety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ATG003 (mecamylamine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Wet AMD, Comentis, ATG003, mecamylamine
Eligibility Criteria
Inclusion Criteria:
- > 55 years of age
- clinical diagnosis of neovascular AMD
Exclusion Criteria:
- confounding ocular condition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
ATG003
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
Secondary Outcome Measures
To evaluate the efficacy of ATG003
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00607750
Brief Title
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CoMentis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Wet AMD, Comentis, ATG003, mecamylamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
ATG003
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ATG003 (mecamylamine)
Intervention Description
1% Ophthalmic solution, eyedrop BID, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eyedrops, BID, 48 weeks
Primary Outcome Measure Information:
Title
To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)
Time Frame
Day 1 - Week 50
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of ATG003
Time Frame
Day 1 - Week 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 55 years of age
clinical diagnosis of neovascular AMD
Exclusion Criteria:
confounding ocular condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Grove, MS
Organizational Affiliation
Comentis, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
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