Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
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ClinicalTrials.gov Identifier: NCT00607750 |
Recruitment Status :
Completed
First Posted : February 6, 2008
Last Update Posted : October 28, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-Related Macular Degeneration | Drug: ATG003 (mecamylamine) Drug: Placebo | Phase 2 |
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 |

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 |
- To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution) [ Time Frame: Day 1 - Week 50 ]
- To evaluate the efficacy of ATG003 [ Time Frame: Day 1 - Week 50 ]

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Ages Eligible for Study: | 56 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 55 years of age
- clinical diagnosis of neovascular AMD
Exclusion Criteria:
- confounding ocular condition

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
Study Director: | Carl Grove, MS | Comentis, Inc. |
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 |
Wet AMD, Comentis, ATG003, mecamylamine |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Mecamylamine Antihypertensive Agents 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 |