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Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration

NCT ID: NCT00716586

Last Updated: 2021-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2017-11-17

Brief Summary

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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

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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.

Conditions

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Retinal Degenerations

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trusopt (2% dorzolamide)

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

Group Type EXPERIMENTAL

2% dorzolamide

Intervention Type DRUG

Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)

Interventions

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2% dorzolamide

Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)

Intervention Type DRUG

Other Intervention Names

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Trusopt

Eligibility Criteria

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Inclusion Criteria

* Presence of cystic macular fluid on OCT testing

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Gerald A. Fishman

Emeritus Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerald A Fishman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 18834580 (View on PubMed)

Other Identifiers

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2005-0551

Identifier Type: -

Identifier Source: org_study_id