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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607750
First Posted: February 6, 2008
Last Update Posted: October 28, 2010
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.
Information provided by:
CoMentis
  Purpose
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 Intervention Phase
Age-Related Macular Degeneration Drug: ATG003 (mecamylamine) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by CoMentis:

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

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

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo eyedrops, BID, 48 weeks
Experimental: ATG003 Drug: ATG003 (mecamylamine)
1% Ophthalmic solution, eyedrop BID, 48 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   56 Years and older   (Adult, Senior)
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
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
Study Director: Carl Grove, MS Comentis, Inc.
  More Information

Responsible Party: Carl Grove, President, CoMentis, Inc.
ClinicalTrials.gov Identifier: NCT00607750     History of Changes
Other Study ID Numbers: ATG003-203
First Submitted: January 23, 2008
First Posted: February 6, 2008
Last Update Posted: October 28, 2010
Last Verified: October 2010

Keywords provided by CoMentis:
Wet AMD, Comentis, ATG003, mecamylamine

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Mecamylamine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action