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| Sponsored by: |
CoMentis |
|---|---|
| Information provided by: | CoMentis |
| ClinicalTrials.gov Identifier: | NCT00607750 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: Placebo
Placebo eyedrops, BID, 48 weeks
|
| ATG003: Experimental |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Retinal Consultants of Arizona | |
| Phoenix, Arizona, United States, 85210 | |
| United States, California | |
| California Retina Consultants | |
| Santa Barbara, California, United States, 93103 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| Retina Vitreous Associate Medical Group | |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| Bascom Palmer Eye Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Texas | |
| Texas Retina Associates | |
| Dallas, Texas, United States, 75231 | |
| Vitreoretinal Consultants | |
| Houston, Texas, United States, 77030 | |
| Study Director: | Henry Hsu, MD | Comentis, Inc. |
More Information
| Responsible Party: | CoMentis, Inc. ( Kim Erby, Clinical Program Manager ) |
| Study ID Numbers: | ATG003-203 |
| Study First Received: | January 23, 2008 |
| Last Updated: | April 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607750 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Wet AMD, Comentis, ATG003, mecamylamine |
|
Neurotransmitter Agents Cholinergic Antagonists Eye Diseases Macular Degeneration Retinal Degeneration Mecamylamine Bevacizumab Tetrahydrozoline |
Cardiovascular Agents Cholinergic Agents Antihypertensive Agents Antibodies Peripheral Nervous System Agents Retinal Diseases Immunoglobulins |
|
Ganglionic Blockers Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Nicotinic Antagonists Eye Diseases Physiological Effects of Drugs Macular Degeneration Retinal Degeneration |
Mecamylamine Cardiovascular Agents Cholinergic Agents Antihypertensive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Retinal Diseases |
