Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

This study has been completed.

Sponsors and Collaborators:	CoMentis Juvenile Diabetes Research Foundation
Information provided by:	CoMentis
ClinicalTrials.gov Identifier:	NCT00536692

Purpose

This is an open-label study evaluating the safety and tolerability of topical ocular mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will be treated for 12 weeks.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: mecamylamine	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Mecamylamine Mecamylamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)

Further study details as provided by CoMentis:

Study Start Date:	September 2007
Study Completion Date:	April 2008

Intervention Details:

topical ocular drops

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

macular edema due to diabetic retinopathy

Exclusion Criteria:

vision loss from other ocular disease
intraocular surgery within 3 months
intraocular anti-VEGF or steroids within 3 months
HbA1c >12

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536692

Locations

United States, California
East Bay Retina Consultants, Inc.
Oakland, California, United States, 94609
United States, Maryland
Johns Hopkins School of Medicine / Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

CoMentis

Juvenile Diabetes Research Foundation

More Information

Study ID Numbers:	ATG003-202
Study First Received:	September 26, 2007
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00536692
Health Authority:	United States: Food and Drug Administration

Keywords provided by CoMentis:

macular edema
DME
diabetic
mecamylamine
Comentis

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Eye Diseases
Mecamylamine
Retinal Degeneration

Macular Degeneration
Edema
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Ganglionic Blockers
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Antagonists
Physiological Effects of Drugs
Cardiovascular Agents

Antihypertensive Agents
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009