Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Illinois at Chicago
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00716586
First received: July 14, 2008
Last updated: December 12, 2014
Last verified: December 2014
  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
Retinal Degenerations
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:


Further study details as provided by University of Illinois at Chicago:

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: 70
Study Start Date: October 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Illinois at Chicago

Additional 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
Study First Received: July 14, 2008
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Edema
Retinal Degeneration
Eye Diseases
Macular Degeneration
Retinal Diseases
Dorzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 25, 2015