Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2008 by University of Illinois.
Recruitment status was Recruiting

Sponsor:

Information provided by:

University of Illinois

ClinicalTrials.gov Identifier:

NCT00716586

First received: July 14, 2008

Last updated: NA

Last verified: July 2008

History: No changes posted

Purpose

Seven patients with X-linked retinoschisis were treated with dorzolamide and the response to this treatment was monitored using OCT. These patients were also tested for the causative gene mutation and the resultant mechanism of functional loss of retinoschisin. It was observed that a response to dorzolamide may be seen irrespective of the mechanism that leads to decrease in function of retinoschisin.

Condition	Intervention	Phase
Juvenile X-Linked Retinoschisis	Drug: dorzolamide	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Dorzolamide Dorzolamide hydrochloride

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:

Decrease in the size of cystic macular lesions as tested by OCT [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	October 2005
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients over the age of 18 years with juvenile X-linked retinoschisis	Drug: dorzolamide 2% dorzolamide- 1 Gtt TID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presence of cystic lesions on OCT testing

Exclusion Criteria:

Allergic reaction to sulpha containing compounds
Intolerance to dorzolamide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716586

Contacts

Contact: Gerald A Fishman, MD

312.996.8939

gerafish@uic.edu

Locations

United States, Illinois
University of Illinois Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Gerald A Fishman, MD 312-996-8939 gerafish@uic.edu

Sponsors and Collaborators

University of Illinois

More Information

No publications provided by University of Illinois

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Walia S, Fishman GA, Molday RS, Dyka FM, Kumar NM, Ehlinger MA, Stone EM. Relation of response to treatment with dorzolamide in X-linked retinoschisis to the mechanism of functional loss in retinoschisin. Am J Ophthalmol. 2009 Jan;147(1):111-115.e1. Epub 2008 Oct 2.

Responsible Party:	Gerald Fishman, MD, University of Illinois at Chicago
ClinicalTrials.gov Identifier:	NCT00716586 History of Changes
Other Study ID Numbers:	IRB-2005-0551
Study First Received:	July 14, 2008
Last Updated:	July 14, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Macular Edema
Retinal Degeneration
Retinoschisis
Macular Degeneration
Retinal Diseases
Eye Diseases
Dorzolamide

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013

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