Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000115
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None