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Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536692
First Posted: September 28, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by:
CoMentis
  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: 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)

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 26, 2007
First Posted: September 28, 2007
Last Update Posted: October 12, 2017
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