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Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

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ClinicalTrials.gov Identifier: NCT00536692
Recruitment Status : Completed
First Posted : September 28, 2007
Last Update Posted : April 8, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: mecamylamine Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)
Study Start Date : September 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Eye Care
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: mecamylamine
    topical ocular drops

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00536692     History of Changes
Other Study ID Numbers: ATG003-202
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: April 8, 2008
Last Verified: April 2008

Keywords provided by CoMentis:
macular edema
DME
diabetic
mecamylamine
Comentis

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
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