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CompletedNCT00000115Updated Sep 17, 2009

Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema

A Phase 2 interventional study of Acetazolamide in Macular Edema, Cystoid, sponsored by National Eye Institute (NEI). Completed. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2009-09-17.

Sponsored by National Eye Institute (NEI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study summary

To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.

Read the 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.

02

Conditions studied

  • Macular Edema, Cystoid

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03

In context

Macular Edema

848 studies on the registry are indexed under Macular Edema; 57 are open to participants now.

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Lead sponsor

National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All

Eligibility criteria

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double

Interventions

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Whitcup SM, Csaky KG, Podgor MJ, Chew EY, Perry CH, Nussenblatt RB. A randomized, masked, cross-over trial of acetazolamide for cystoid macular edema in patients with uveitis. Ophthalmology. 1996 Jul;103(7):1054-62; discussion 1062-3. doi: 10.1016/s0161-6420(96)30567-8. PubMed 8684794 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000115
First posted
Sep 24, 1999
Start date
Dec 1990
Completion
Jun 1994
Last update
Sep 17, 2009
View the source record on ClinicalTrials.gov ↗

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