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Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Primary Purpose

Retinal Degenerations

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2% dorzolamide
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Degenerations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of cystic macular fluid on OCT testing

Exclusion Criteria:

  • Allergic reaction to sulpha containing compounds
  • Intolerance to dorzolamide (Trusopt)

Sites / Locations

  • University of Illinois Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trusopt (2% dorzolamide)

Arm Description

Intent to treat population. All participants assigned to Trusopt (2% dorzolamide)

Outcomes

Primary Outcome Measures

Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)
Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
Macular fluid measured subjectively by OCT. A 25% or greater reduction of macular fluid was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Secondary Outcome Measures

Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart
Visual acuity measured in LogMAR units. Reading 7 letters or more on a visual chart, from baseline to most recent visit, was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

Full Information

First Posted
July 14, 2008
Last Updated
October 17, 2021
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00716586
Brief Title
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Official Title
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (Actual)
Primary Completion Date
August 11, 2015 (Actual)
Study Completion Date
November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina. Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision. This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.
Detailed Description
Patients with certain retinal degenerations will be asked to take part in a research study about the use of a topically applied eye drop for treating fluid in the central part of the retina (macular edema). In the current study, investigators propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its effectiveness 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 at least of one line (7 letters) or more of vision will be considered as a clinically significant improvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Degenerations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trusopt (2% dorzolamide)
Arm Type
Experimental
Arm Description
Intent to treat population. All participants assigned to Trusopt (2% dorzolamide)
Intervention Type
Drug
Intervention Name(s)
2% dorzolamide
Other Intervention Name(s)
Trusopt
Intervention Description
Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
Primary Outcome Measure Information:
Title
Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)
Description
Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
Time Frame
Baseline and most recent visit (2 month up to 36 months)
Title
Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
Description
Macular fluid measured subjectively by OCT. A 25% or greater reduction of macular fluid was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
Time Frame
Baseline and most recent visit (2 months up to 36 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart
Description
Visual acuity measured in LogMAR units. Reading 7 letters or more on a visual chart, from baseline to most recent visit, was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.
Time Frame
Baseline and most recent visit (2 months up to 36 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of cystic macular fluid on OCT testing Exclusion Criteria: Allergic reaction to sulpha containing compounds Intolerance to dorzolamide (Trusopt)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald A Fishman, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18834580
Citation
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.
Results Reference
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Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

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