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Trial registered on ANZCTR


Registration number
ACTRN12611001225909
Ethics application status
Approved
Date submitted
25/11/2011
Date registered
29/11/2011
Date last updated
29/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of topical glucose on vitreous glucose concentration
Scientific title
The effect of topical glucose on vitreous glucose concentration in 20 non-diabetic subjects.
Secondary ID [1] 273469 0
'Nil'
Universal Trial Number (UTN)
U1111-1126-0804
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitreous glucose concentration of the Eye 279259 0
Condition category
Condition code
Eye 279458 279458 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: The pre-operative eye will receive a drop of sterile glucose (10microlitres), every 5 minutes for one hour prior to planned elective vitrectomy.
6 patients will receive saline eye drops and serve as controls.
The next 2 patients will receive 10% glucose drops.
If no adverse effects are observed then the next 6 patients will receive 25%
glucose.
If > 2 patient develop more than mild toxicity then we will revert back to 10 %
glucose.
If = 2 patient develop toxicity at this dose the next 6 patients will receive 50%
glucose.
If > 2 patients develop more than mild toxicity we will revert back to 25%
glucose.
If patients develop toxicity at 10% glucose, the study will be ceased.
Outcome: Intraoperatively, as part of the routine vitrectomy, a 100 micolitre sample of vitreous will be collected within 30 minutes of the last drop instilled. This has no effect on the outcome of the procedure. The sample will be sent for glucose concentration analysis.
Intervention code [1] 283786 0
Treatment: Other
Comparator / control treatment
The first six subjects will be the controls, they will only receive saline to the eye.
Control group
Placebo

Outcomes
Primary outcome [1] 286017 0
Glucose Concentration analysis
Timepoint [1] 286017 0
Intraoperatively, as part of the routine vitrectomy, a 100 microlitre sample of vitreous will be collected within 30 minutes of the last drop instilled. This has no effect on the outcome of the procedure. The sample will be sent for glucose concentration analysis.
Secondary outcome [1] 295022 0
Statistical Analysis
The mean vitreous glucose concentration in non-diabetics has been reported as 3.5 mmol
(SD 1.8mmol)
Timepoint [1] 295022 0
The statistical analysis has an ANOVA model with 3 groups: control; 25% glucose; 50%
glucose. (Note that the 10% glucose concentration is included for dose escalation safety
purposes but cannot be included in the analysis)
Topical Glucose & Vitrectomy, Casson R Protocol Version 2 7th Sept 2010 4
We estimate a vitreous glucose concentration of 3.5 in the control group, 5 mmol in the
25% group and 6.5mmo in the 50% group.
Using Stata fpower function to calculate the sample size based on an estimated pooled
standard deviation of 1.8 and the difference between the largest and smallest mean of
3mmol, we require 6 patients in each group for 78.5% power at alpha value of 0.1.

Eligibility
Key inclusion criteria
Subjects: 20 non-diabetic will be recruited from the the vitreoretinal service at the RAH
Inclusion Criteria:
Patients will have been booked to undergo elective vitrectomy i.e these patients will already be undergoing a clinically-indicated vitrectomy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of diabetes mellitus
Vitreous haemorrhage

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
6 patients will receive saline eye drops and serve as controls.
The next 2 patients will receive 10% glucose drops.
If no adverse effects are observed then the next 6 patients will receive 25% glucose.
If > 2 patient develop more than mild toxicity then we will revert back to 10 % glucose.
If = 2 patient develop toxicity at this dose the next 6 patients will receive 50% glucose.
If > 2 patients develop more than mild toxicity we will revert back to 25% glucose.
If patients develop toxicity at 10% glucose, the study will be ceased
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subject in order of screening and consenting.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
a modified dose escalation bioavailability study
Phase
Phase 1
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284263 0
Hospital
Name [1] 284263 0
Ophthalmology Network
Address [1] 284263 0
Royal Adelaide Hospital
North Tce, Adelaide
South Australia 5000
Country [1] 284263 0
Australia
Primary sponsor type
Individual
Name
Robert Casson
Address
Ophthalmology Network
Royal Adelaide Hospital
North Tce, Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 269215 0
None
Name [1] 269215 0
Address [1] 269215 0
Country [1] 269215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286223 0
Royal Adelaide Ethics Committee
Ethics committee address [1] 286223 0
Level 3, Hanson Institute
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Ethics committee country [1] 286223 0
Australia
Date submitted for ethics approval [1] 286223 0
23/07/2010
Approval date [1] 286223 0
10/09/2010
Ethics approval number [1] 286223 0
100815

Summary
Brief summary
To determine whether a brief period of topical glucose application to the eye can transiently elevate the vitreous glucose concentration.

This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature

We aim to proceed to a human trial using topical glucose as a neurorecovery agent in glaucoma patients. However, before proceeding to this trial we need to establish that topical glucose can elevate the vitreous glucose concentration.
This is a Phase I type study in the sense that glucose eye drops have not been previously used therapeutically and we are not assessing efficacy. But it differs from a classic Phase I study in the sense that we are not seeking to assess the dose at which the glucose becomes unacceptably toxic; however, we believe that a modified dose escalation strategy would provide the optimal safety and still provide the necessary vitreous concentration data for statistical analysis.
Trial website
'nil'
Trial related presentations / publications
'nil'
Public notes

Contacts
Principal investigator
Name 33439 0
Address 33439 0
Country 33439 0
Phone 33439 0
Fax 33439 0
Email 33439 0
Contact person for public queries
Name 16686 0
Kylie Dansie
Address 16686 0
Ophthalmology
Lev 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 16686 0
Australia
Phone 16686 0
61 8 8222 2732
Fax 16686 0
61 8 8222 2741
Email 16686 0
kylie.dansie@health.sa.gov.au
Contact person for scientific queries
Name 7614 0
Robert Casson
Address 7614 0
Ophthalmology
Lev 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 7614 0
Australia
Phone 7614 0
61 8 8222 2732
Fax 7614 0
61 8 8222 2741
Email 7614 0
robert.casson@adelaide.edu.au

No data has been provided for results reporting
Summary results
Not applicable