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Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

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ClinicalTrials.gov Identifier: NCT00716586
Recruitment Status : Unknown
Verified December 2014 by University of Illinois at Chicago.
Recruitment status was:  Recruiting
First Posted : July 16, 2008
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):
University of Illinois at Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Retinal Degenerations Drug: dorzolamide Phase 4

Detailed Description:

A percentage of patients with retinal degeneration, a group of progressive blinding diseases, are known to develop fluid within the center part of their retina known as macular edema. Previous studies have documented that an oral form of carbonic anhydrase inhibitor (acetazolamide) can be effective in reducing the amount of macular edema in such patients (Archives of Ophthalmology, 106:1190-1195, 1988; 107:1445-1452, 1989). However, the use of the oral form of this medication is known to cause clinically significant side effects such as fatigue and loss of appetite.

A topical form of carbonic anhydrase inhibitor, (Trusopt) has promise for having a similar beneficial effect on the retinal fluid while not having the systemic side effects observed with the oral form of medication.

In the current study, we propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its efficacy in reducing the amount of retinal fluid in patients with RD and macular edema. The methods will involve an initial one month treatment with topical Trusopt three times a day in each eye. After a period of one month, patients will return for a follow-up examination. At baseline, they will have had a measurement of their center vision and a measurement of their macular fluid with a photographic-like procedure termed optical coherence tomography (OCT). After the one month period of treatment, they will again have a measurement of their vision and re-evaluation with OCT. An improvement of one line or more of vision will be considered as a significant improvement. Since the short-term intervisit variability in the area of macular edema in patients with RD can vary from 11% to 16%, a reduction in fluid of at least 25% in area will be considered as a clinically significant improvement of macular edema.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Study Start Date : October 2005
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Patients over the age of 18 years with cystoid macular edema and retinal degeneration will be treated with Trusopt.
Drug: dorzolamide
2% dorzolamide- 1 Gtt TID
Other Name: Trusopt

Primary Outcome Measures :
  1. Decrease in the size of cystic macular lesions as tested by OCT [ Time Frame: 4-6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presence of cystic lesions on OCT testing

Exclusion Criteria:

  • Allergic reaction to sulpha containing compounds
  • Intolerance to dorzolamide

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716586

Contact: Gerald A Fishman, MD 312.996.8939 gerafish@uic.edu

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 at Chicago
Principal Investigator: Gerald A Fishman, MD University of Illinois at Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00716586     History of Changes
Other Study ID Numbers: IRB-2005-0551
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Macular Edema
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Eye Diseases
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action