Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000258853
Ethics application status
Not yet submitted
Date submitted
29/02/2012
Date registered
1/03/2012
Date last updated
1/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of Resveratrol in patients with Glaucoma
Scientific title
An open label clinical pilot study of the effect of resveratrol in patients with Glaucoma
Secondary ID [1] 280058 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 285968 0
Condition category
Condition code
Eye 286153 286153 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dose escalation study where patients with glaucoma are given 1 gram Resveratrol (oral capsule) daily for 2 weeks followed by 5 grams of Resveratrol (oral capsule) daily for 2 weeks.
Intervention code [1] 284377 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286624 0
Change in electroretinogram (ERG) recordings
Timepoint [1] 286624 0
2 weeks, 4 weeks and 8 weeks
Secondary outcome [1] 296295 0
Nil
Timepoint [1] 296295 0
N/A

Eligibility
Key inclusion criteria
Patients with ocular hypertension, mild to moderate glaucoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Advanced glaucoma
Pregnancy
Severe renal or hepatic impairment
Documented allergy to Resveratrol

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled from the Glaucoma clinics at the Royal Victorian Eye & Ear Hospital. There will be no allocation or concealment procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
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)

Funding & Sponsors
Funding source category [1] 284805 0
Hospital
Name [1] 284805 0
Royal Victorian Eye & Ear Hospital
Country [1] 284805 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Eye Research Australia
Address
32 Gisborne Street
East Melbourne
VICTORIA
3002
Country
Australia
Secondary sponsor category [1] 283687 0
None
Name [1] 283687 0
Address [1] 283687 0
Country [1] 283687 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286795 0
Royal Victorian Eye & Ear Human Research and Ethics Commitee
Ethics committee address [1] 286795 0
32 Gisborne Street
East Melbourne
VICTORIA
3002
Ethics committee country [1] 286795 0
Australia
Date submitted for ethics approval [1] 286795 0
02/04/2012
Approval date [1] 286795 0
Ethics approval number [1] 286795 0

Summary
Brief summary
The primary aims of this study are to determine whether the electroretinogram (ERG), particularly the Phototopic negative response (PhNR) can be improved in patients with glaucoma who take oral supplementation with Resveratrol (RSV) of different doses.
Participants undertake full-field ERG testing and their recordings of responses are examined to determine whether there is a difference in ERG parameters between glaucoma patients taking different doses of RSV and after a wash-out period after stopping RSV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33854 0
Address 33854 0
Country 33854 0
Phone 33854 0
Fax 33854 0
Email 33854 0
Contact person for public queries
Name 17101 0
Dr. Dan Nguyen
Address 17101 0
32 Gisborne Street
East Melbourne
3002
VICTORIA
Country 17101 0
Australia
Phone 17101 0
+61 3 9929 8666
Fax 17101 0
Email 17101 0
[email protected]
Contact person for scientific queries
Name 8029 0
Dr. Dan Nguyen
Address 8029 0
Royal Victorian Eye & Ear Hospital
32 Gisborne Street
East Melbourne
VICTORA 3002
Country 8029 0
Australia
Phone 8029 0
+61 3 9929 8666
Fax 8029 0
Email 8029 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.