Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00716586|
Recruitment Status : Unknown
Verified December 2014 by University of Illinois at Chicago.
Recruitment status was: Recruiting
First Posted : July 16, 2008
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Retinal Degenerations||Drug: dorzolamide||Phase 4|
A percentage of patients with retinal degeneration, a group of progressive blinding diseases, are known to develop fluid within the center part of their retina known as macular edema. Previous studies have documented that an oral form of carbonic anhydrase inhibitor (acetazolamide) can be effective in reducing the amount of macular edema in such patients (Archives of Ophthalmology, 106:1190-1195, 1988; 107:1445-1452, 1989). However, the use of the oral form of this medication is known to cause clinically significant side effects such as fatigue and loss of appetite.
A topical form of carbonic anhydrase inhibitor, (Trusopt) has promise for having a similar beneficial effect on the retinal fluid while not having the systemic side effects observed with the oral form of medication.
In the current study, we propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its efficacy 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 of one line or more of vision will be considered as a significant improvement. Since the short-term intervisit variability in the area of macular edema in patients with RD can vary from 11% to 16%, a reduction in fluid of at least 25% in area will be considered as a clinically significant improvement of macular edema.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Patients over the age of 18 years with cystoid macular edema and retinal degeneration will be treated with Trusopt.
2% dorzolamide- 1 Gtt TID
Other Name: Trusopt
- Decrease in the size of cystic macular lesions as tested by OCT [ Time Frame: 4-6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716586
|Contact: Gerald A Fishman, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Gerald A Fishman, MD 312-996-8939 email@example.com|
|Principal Investigator:||Gerald A Fishman, MD||University of Illinois at Chicago|