Macular Edema, CystoidPhase 2NCT00000115
Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema
A Phase 2 study testing Acetazolamide in people with Macular Edema, Cystoid, run by National Eye Institute (NEI).
Trial summary
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Macular Edema, Cystoid
- What is being tested?
- Acetazolamide
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1990to Jun 1994
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Child, Adult, Older adult
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.
About this study
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.
- Conditions
- Macular Edema, Cystoid
- Being tested
- Acetazolamide
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startDec 1990
- Study completionJun 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular Edema, CystoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000115
- Sponsor's protocol ID
- NEI-11
- Status last verified
- Sep 2009
- First submitted
- 23 Sep 1999
- Last updated
- 17 Sep 2009
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema
- ClinicalTrials.gov ID
- NCT00000115
- Acronym / sponsor ID
- NEI-11
- Conditions
- Macular Edema, Cystoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Dec 1990
- Study completion
- Jun 1994 (actual)
- First posted
- 24 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
- Background: PubMed 8684794Whitcup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide in people with Macular Edema, Cystoid, run by National Eye Institute (NEI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2009.