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

July 14, 2008
December 12, 2014
October 2005
December 2016   (final data collection date for primary outcome measure)
Decrease in the size of cystic macular lesions as tested by OCT [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00716586 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinal Degenerations
Drug: dorzolamide
2% dorzolamide- 1 Gtt TID
Other Name: Trusopt
Experimental: 1
Patients over the age of 18 years with cystoid macular edema and retinal degeneration will be treated with Trusopt.
Intervention: Drug: dorzolamide
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. doi: 10.1016/j.ajo.2008.07.041. Epub 2008 Oct 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of cystic lesions on OCT testing

Exclusion Criteria:

  • Allergic reaction to sulpha containing compounds
  • Intolerance to dorzolamide
Male
18 Years and older
No
Contact: Gerald A Fishman, MD 312.996.8939 gerafish@uic.edu
United States
 
NCT00716586
IRB-2005-0551
No
University of Illinois at Chicago
University of Illinois at Chicago
Not Provided
Principal Investigator: Gerald A Fishman, MD University of Illinois at Chicago
University of Illinois at Chicago
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP