- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000115
Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema
Study Overview
Detailed Description
Uveitis, an intraocular inflammatory disease, is the cause of about 10 percent of visual impairment in the United States. Uveitis may lead to many sight-threatening conditions, including cataract, vitreal opacities, glaucoma, and, most commonly, cystoid macular edema. Reduction of swelling or edema within the retina depends on the movement of fluid from the retina through the choroid. A number of studies indicate that this process requires active transport of fluid ions by the retinal pigment epithelium and may involve the carbonic anhydrase system. Current treatment of uveitis-associated cystoid macular edema requires the use of immunosuppressive or anti-inflammatory agents. However, many patients are either resistant or intolerant to this therapy. Recent reports suggested that acetazolamide, a carbonic anhydrase inhibitor that is used to lower intraocular pressure in some glaucoma patients, might be safe and effective in reducing uveitis-associated cystoid macular edema.
Because the course of ocular inflammatory disease can be variable, a double-masked, randomized, crossover trial was designed to test the efficacy of acetazolamide compared with a placebo for the treatment of uveitis-associated cystoid macular edema. Randomized adult patients received either oral acetazolamide sodium 500 mg or a matched placebo every 12 hours for the first 4 weeks of the study. Children 8 years of age or older received a lesser dose based on body weight. Following a 4-week period, during which no medication was given, patients then received a 4-week course of the opposite medication. Primary end points included reduction in cystoid macular edema (graded on fluorescein angiography) and improvement in visual acuity (measured on standardized Early Treatment Diabetic Retinopathy Study [ETDRS] charts). Laser acuity was also assessed as a secondary outcome variable. Adverse effects of the acetazolamide therapy were monitored by clinical and laboratory examinations.
A total of 40 patients were recruited for the study. Patients were seen at the beginning of the study for baseline measurements and at 4, 8, and 12 weeks after enrollment into the study.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Males and females 8 years of age or older and weighing at least 35 kg (77 lb) were eligible for the study. Patients had to have a best corrected visual acuity of 20/40 or worse in at least one eye with cystoid macular edema demonstrable on fluorescein angiography.
Patients were allowed to receive systemic therapy for their uveitis. Exclusion criteria included current use of acetazolamide as part of a therapeutic regimen; a history of hypersensitivity reactions to acetazolamide, sulfonamides, or angiography dye; unclear ocular media that would obscure fluorescein angiography; macular subretinal neovascularization or a macular hole; or inability to take acetazolamide for medical reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEI-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Edema, Cystoid
-
Federico II UniversityCompletedPseudophakic Cystoid Macular Edema
-
Quan Dong NguyenOculis; Global Ophthalmic Research Center (GORC)RecruitingUveitis Related Cystoid Macular Edema | Cystoid Macular Edema, PostoperativeUnited States
-
Vance Thompson Vision - MTUnknownPatient Preference | Post-Operative Inflammation | Patient Outcomes | Grade of Post-Operative Cystoid Macular Edema | Rate of Post-Operative Cystoid Macular EdemaUnited States
-
Postgraduate Institute of Medical Education and...CompletedDiabetic Macular Edema | Cataract | Vision Disorders | Macular Edema, Cystoid | Cystoid Macular Edema Following Cataract SurgeryIndia
-
Asociación para Evitar la Ceguera en MéxicoUnknownCystoid Macular EdemaMexico
-
California Retina ConsultantsRegeneron PharmaceuticalsCompletedDiabetic Macular Edema | Cystoid Macular EdemaUnited States
-
Dongyang People's HospitalRecruiting
-
University of MiamiGenentech, Inc.CompletedUveitic Cystoid Macular EdemaUnited States
-
Massachusetts Eye and Ear InfirmaryRecruitingCystoid Macular EdemaUnited States
-
University of CataniaRecruitingCystoid Macular EdemaItaly
Clinical Trials on Acetazolamide
-
Asan Medical CenterUnknownVentilator Weaning | Alkalosis, MetabolicKorea, Republic of
-
University of UtahCompletedProphylaxis of Acute Mountain SicknessUnited States
-
US Department of Veterans AffairsWithdrawnStroke | Sleep Apnea, Obstructive
-
Association pour la Recherche en Physiologie de...Universidad Peruana Cayetano Heredia; University of Paris 13; Legs PoixCompleted
-
Centro Cardiologico MonzinoCompletedChronic Heart FailureItaly
-
Stanford UniversityCompletedAcute Mountain SicknessUnited States
-
University Hospital, AntwerpUnknown
-
University of ZurichCompletedObstructive Sleep Apnea SyndromeSwitzerland
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAcute Mountain SicknessKyrgyzstan