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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: ATG003 (mecamylamine) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Placebo eyedrops, BID, 48 weeks
Experimental: ATG003 Drug: ATG003 (mecamylamine)
1% Ophthalmic solution, eyedrop BID, 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) [ Time Frame: Day 1 - Week 50 ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of ATG003 [ Time Frame: Day 1 - Week 50 ]

Eligibility Criteria
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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • confounding ocular condition
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607750


Sponsors and Collaborators
CoMentis
Investigators
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Study Director: Carl Grove, MS Comentis, Inc.
More Information
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Responsible Party: Carl Grove, President, CoMentis, Inc.
ClinicalTrials.gov Identifier: NCT00607750    
Other Study ID Numbers: ATG003-203
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010
Keywords provided by CoMentis:
Wet AMD, Comentis, ATG003, mecamylamine
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Mecamylamine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
 Physiological Effects of Drugs
Growth Inhibitors
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action