Topical Ocular Mecamylamine in Diabetic Macular Edema (DME) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	September 26, 2007
Last Updated Date	April 3, 2008
Start Date ^†	September 2007
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00536692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)
Official Title ^†	Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)
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.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Single Group Assignment
Condition ^†	Diabetic Macular Edema
Intervention ^†	Drug: mecamylamine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†
Completion Date	April 2008
Primary Completion Date
Eligibility 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00536692
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	CoMentis
Collaborators ^††	Juvenile Diabetes Research Foundation
Investigators ^†
Information Provided By	CoMentis
Verification Date	April 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.