Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

NCT ID: NCT00536692

Last Updated: 2008-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Keywords

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macular edema DME diabetic mecamylamine Comentis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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mecamylamine

topical ocular drops

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

CoMentis

INDUSTRY

Sponsor Role lead

Locations

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East Bay Retina Consultants, Inc.

Oakland, California, United States

Site Status

Johns Hopkins School of Medicine / Wilmer Eye Institute

Baltimore, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Campochiaro PA, Shah SM, Hafiz G, Heier JS, Lit ES, Zimmer-Galler I, Channa R, Nguyen QD, Syed B, Do DV, Lu L, Monk J, Cooke JP, Kengatharan MK, Hsu HH. Topical mecamylamine for diabetic macular edema. Am J Ophthalmol. 2010 May;149(5):839-51.e1. doi: 10.1016/j.ajo.2009.12.005. Epub 2010 Feb 26.

Reference Type DERIVED
PMID: 20189159 (View on PubMed)

Other Identifiers

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ATG003-202

Identifier Type: -

Identifier Source: org_study_id