NCT00536692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 8, 2008

Status Verified

April 1, 2008

First QC Date

September 26, 2007

Last Update Submit

April 3, 2008

Conditions

Diabetic Macular Edema

Keywords

macular edemaDMEdiabeticmecamylamineComentis

Interventions

mecamylamineDRUG

topical ocular drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • macular edema due to diabetic retinopathy

You may not qualify if:

  • vision loss from other ocular disease
  • intraocular surgery within 3 months
  • intraocular anti-VEGF or steroids within 3 months
  • HbA1c \>12

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

East Bay Retina Consultants, Inc.

Oakland, California, 94609, United States

Location

Johns Hopkins School of Medicine / Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 20189159DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 28, 2007

Study Start

September 1, 2007

Study Completion

April 1, 2008

Last Updated

April 8, 2008

Record last verified: 2008-04

Locations

US(3)