Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

Sponsor

CoMentis (Industry)

Overall Status

Completed

CT.gov ID

NCT00536692

Collaborator

Juvenile Diabetes Research Foundation (Other)

Locations

Duration (Months)

Study Details

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

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 :

Sep 1, 2007

Actual Study Completion Date :

Apr 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	East Bay Retina Consultants, Inc.	Oakland	California	United States	94609
2	Johns Hopkins School of Medicine / Wilmer Eye Institute	Baltimore	Maryland	United States	21287
3	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114