Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Study Overview
=================
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.

Official Title
-----------------
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Conditions
-----------------
Retinal Degenerations

Intervention / Treatment
-----------------
* Drug: 2% dorzolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of cystic macular fluid on OCT testing Exclusion Criteria: Allergic reaction to sulpha containing compounds Intolerance to dorzolamide (Trusopt)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trusopt (2% dorzolamide)<br>Intent to treat population. All participants assigned to Trusopt (2% dorzolamide) | Drug: 2% dorzolamide<br>* Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)<br>* Other names: Trusopt;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and most recent visit (2 month up to 36 months) | 
| 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. | Baseline and most recent visit (2 months up to 36 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and most recent visit (2 months up to 36 months) |