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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of ATG003 [ Time Frame: Day 1 - Week 50 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • confounding ocular condition
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607750

Sponsors and Collaborators
CoMentis
Investigators
Study Director: Carl Grove, MS Comentis, Inc.
  More Information

No publications provided

Responsible Party: Carl Grove, President, CoMentis, Inc.
ClinicalTrials.gov Identifier: NCT00607750     History of Changes
Other Study ID Numbers: ATG003-203
Study First Received: January 23, 2008
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mecamylamine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014