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

Sponsor:	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:	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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Mecamylamine Bevacizumab Mecamylamine hydrochloride

U.S. FDA Resources

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

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 February 09, 2012