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Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00536692
First received: September 26, 2007
Last updated: April 3, 2008
Last verified: April 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by CoMentis:

Study Start Date: September 2007
Study Completion Date: April 2008
Intervention Details:
    Drug: mecamylamine
    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

No publications provided by CoMentis

Additional 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
Study First Received: September 26, 2007
Last Updated: April 3, 2008
Health Authority: United States: Food and Drug Administration

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
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 June 18, 2013