Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000476033
Ethics application status
Not yet submitted
Date submitted
12/04/2010
Date registered
10/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Acetazolamide in X-linked Retinoschisis
Scientific title
The effect of Acetazolamide on visual acuity, retinal thickness and macular cyst size in patients with X-linked retinoschisis
Secondary ID [1] 251989 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
X-linked Retinoschisis 257140 0
Condition category
Condition code
Eye 257297 257297 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral acetazolamide 200mg twice a day >60kg or 125mg twice <60kg.

Participants allocated to the acetazolamide/placebo study arm will receive acetazolamide first, followed by placebo, and vice versa in the placebo/acetazolamide. The duration of acetazolamide will be three months. The mode of administration is oral capsule.

Cross over occurs at 3 months following first dose of treatment. Measurements at are done at 0, 3 and 6months. Hence no "wash-out" period is required.
Intervention code [1] 256296 0
Treatment: Drugs
Comparator / control treatment
placebo: 20mg microcellulose oral pill, twice a day for 3 months.
Control group
Placebo

Outcomes
Primary outcome [1] 258202 0
Best corrected visual acuity using Snellen and Log MAR Chart
Timepoint [1] 258202 0
0, 3 and 6 months
Primary outcome [2] 258203 0
Retinal thickness using optical coherence tomography (OCT)
Timepoint [2] 258203 0
0, 3 and 6 months
Primary outcome [3] 258204 0
Macular cyst size using optical coherence tomography (OCT)
Timepoint [3] 258204 0
0, 3 and 6 months
Secondary outcome [1] 263854 0
Nil
Timepoint [1] 263854 0
Ni

Eligibility
Key inclusion criteria
- Patients with X-linked retinoschisis diagnosis and stable ocular fixation with no clinically significant media opacities.

There will be no age restrictions
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hypersensitivity to sulphonamides and sulphonamide derivatives
- Women who are pregnant
- People in existing dependent or unequal relationships
- People highly dependent on medical care
- Aboriginal and/or Torres Striait Islander People
- People who may be involved in illegal activity
- People with an intellectual or mental impairment
- People whose primary language is other than English.
- A refractive error greater than ±6 diopters (D) sphere
- Uveitis
- Optic neuropathy
- The presence of nystagmus or any other retinal diseases affecting the macula other than retinoschisis
- A recent history (<6months) of intraocular surgery, and poor optical coherent tomography (OCT) image quality.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with X-linked retinoschisis diagnosis will be identified from the Save Sight Institute computerised medical records and invited to participate in the study. Patients will be sent a letter from the researchers inviting them to participate in the clinical trial. The letter contains details of the study including: aims, study procedure and method, risks, benefits, cost, voluntary participation and confidentiality.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using coin-tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2908 0
2000

Funding & Sponsors
Funding source category [1] 256794 0
University
Name [1] 256794 0
The University of Sydney
Country [1] 256794 0
Australia
Funding source category [2] 257031 0
Self funded/Unfunded
Name [2] 257031 0
Country [2] 257031 0
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 256382 0
None
Name [1] 256382 0
Address [1] 256382 0
Country [1] 256382 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258817 0
Sydney South West Area Health Service Ethic Review Committee (Royal Prince Alfred Zone)
Ethics committee address [1] 258817 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 258817 0
Australia
Date submitted for ethics approval [1] 258817 0
26/05/2010
Approval date [1] 258817 0
Ethics approval number [1] 258817 0

Summary
Brief summary
X-linked retinoschisis is a genetic eye disorder characterised by abnormal splitting of the retina, resulting in a loss of vision. Currently there is no treatment available for X-linked retinoschisis. However, an improvement in sight has been reported following the use of topical and oral acetazolamide in people with X-linked retinoschisis. Hence, the objective of this study is to investigate whether oral acetazolamide improves the sight of people with X-linked retinoschisis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31040 0
Address 31040 0
Country 31040 0
Phone 31040 0
Fax 31040 0
Email 31040 0
Contact person for public queries
Name 14287 0
Dr Michael Wei
Address 14287 0
182/116 Maroubra Road Maroubra NSW 2035
Country 14287 0
Australia
Phone 14287 0
+61 434020435
Fax 14287 0
Email 14287 0
[email protected]
Contact person for scientific queries
Name 5215 0
Dr John Grigg
Address 5215 0
Save Sight Institute
Sydney Eye Hospital Campus
8 Macquarie Street
Sydney NSW 2000
Country 5215 0
Australia
Phone 5215 0
+61 2 9382 7302
Fax 5215 0
Email 5215 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.