Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Retinal Degenerations Clinical Trial

Official title:

Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716586
• Other study ID #: 2005-0551
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: November 17, 2017

Study information

• Verified date: October 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 17, 2017
• Est. primary completion date: August 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of cystic macular fluid on OCT testing

Exclusion Criteria:

• Allergic reaction to sulpha containing compounds

• Intolerance to dorzolamide (Trusopt)

Related Conditions & MeSH terms

• Macular Edema
• Retinal Degeneration
• Retinal Degenerations

Intervention

Drug:
• 2% dorzolamide
Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)

Locations

Country	Name	City	State
United States	University of Illinois Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)