Topical Ocular Mecamylamine in Diabetic Macular Edema (DME) | NCT00536692

Studies
Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)

NCT00536692

Sponsor

CoMentis

Status

Completed

Last Update Posted

Apr 8, 2008Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Diabetic Macular Edema

Interventions

mecamylamine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Sep 26, 2007

First Submission Date that Met QC Criteria

Sep 26, 2007

First Posted Date

Sep 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2008

Last Update Posted Date

Apr 8, 2008Estimated

Name	Class
Juvenile Diabetes Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
mecamylamine	Drug	topical ocular drops

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Bay Retina Consultants, Inc.		Oakland	California	94609	United States
Johns Hopkins School of Medicine / Wilmer Eye Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20189159	Derived	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.

Type	Date	Date Unknown
Release	Aug 16, 2010
Reset	Sep 9, 2010

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D009636	Norbornanes
D001643	Bridged Bicyclo Compounds
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic