Clinical trial NCT00716586: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Degenerations
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Presence of cystic macular fluid on OCT testing

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline and most recent visit (2 month up to 36 months)
measure: Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)
timeFrame: Baseline and most recent visit (2 months up to 36 months)
Secondary outcomes:
measure: Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart
timeFrame: Baseline and most recent visit (2 months up to 36 months)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Gerald A Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.