Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Drug: dorzolamide
    • 2% dorzolamide- 1 Gtt TID

Arms, Groups and Cohorts

  • Experimental: 1
    • Patients over the age of 18 years with cystoid macular edema and retinal degeneration will be treated with Trusopt.

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in the size of cystic macular lesions as tested by OCT
    • Time Frame: 4-6 months

Participating in This Clinical Trial

Inclusion Criteria

  • Presence of cystic lesions on OCT testing

Exclusion Criteria

  • Allergic reaction to sulpha containing compounds
  • Intolerance to dorzolamide

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gerald A Fishman, MD, Principal Investigator, University of Illinois at Chicago
  • Overall Contact(s)
    • Gerald A Fishman, MD, 312.996.8939, gerafish@uic.edu

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