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Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mecamylamine
Sponsored by
CoMentis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring macular edema, DME, diabetic, mecamylamine, Comentis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • East Bay Retina Consultants, Inc.
  • Johns Hopkins School of Medicine / Wilmer Eye Institute
  • Ophthalmic Consultants of Boston

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 26, 2007
Last Updated
April 3, 2008
Sponsor
CoMentis
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00536692
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CoMentis
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
macular edema, DME, diabetic, mecamylamine, Comentis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
mecamylamine
Intervention Description
topical ocular drops

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
East Bay Retina Consultants, Inc.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Johns Hopkins School of Medicine / Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20189159
Citation
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.
Results Reference
derived

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Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

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