Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000422729
Ethics application status
Approved
Date submitted
5/04/2013
Date registered
16/04/2013
Date last updated
16/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical trial of slow versus fast intravitreal injection of ranibizumab (lucentis (Registered Trademark)) and its impact on intraocular pressure

Scientific title
A randomised clinical trial of slow versus fast intravitreal injection of ranibizumab (lucentis (Registered Trademark)) and its impact on intraocular pressure in patients with age-related macular degeneration (AMD)
Secondary ID [1] 282261 0
none
Universal Trial Number (UTN)
Trial acronym
Speed IOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraocular pressure elevation following intravitreal injections 288787 0
Condition category
Condition code
Eye 289148 289148 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will be patients who are receiving lucentis injections for the treatment of the Age-related Macular Degeneration. The trial will involve only measuring the intraocular pressure (IOP) before and after the injections to investigate the different impact of slow versus fast injections on IOP. The study will run for 4 months and involve 2 study visits. Participants will receive the intravitreal injection that they are already receiving for AMD. The IOP will be measured before the injection, 2 minutes after the injection and 15 minutes after the injection. Study participants will be randomly assigned to two groups (group A and group B). Participants assigned to group A will receive their intravitreal injection as a quick push in the first visit and slowly (over 3-4 seconds) in the second visit. Participants assigned to group B will receive the opposite allocation. The two injections will be given 4-12 weeks apart according to the scheduled treatment for the participants AMD."
Intervention code [1] 286884 0
Prevention
Comparator / control treatment
This is a crossover study and each participant will be his/her own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289256 0
The mean change in IOP 2 minutes after injection in comparison with pre-injection IOP measurement. Intraocular pressure of the study eye will be measured using Goldmann applanation tonometers and Icare tonometer.
Timepoint [1] 289256 0
2 minutes after the injection
Secondary outcome [1] 302115 0
The mean change in IOP 15 minutes after injection in comparison with the pre-injection level.
Intraocular pressure of the study eye will be measured using Goldmann applanation tonometers and Icare tonometer.
Timepoint [1] 302115 0
15 minutes after injection.

Secondary outcome [2] 302116 0
Any adverse effects associated with the intravitreal injections.
Timepoint [2] 302116 0
Monitored throughout the 4 month study period. At each visit patients will be asked if they have any adverse events.

Eligibility
Key inclusion criteria
1. Age=or>50 years.
2. Clinical need for a therapeutic ranibizumab intravitreal injection for AMD.
3. A written informed consent is required before enrolling patients in the study.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with advanced glaucoma will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Based on the investigator’s clinical experience, 50% of eyes which will receive the fast injections will have IOP elevation of > 40 mmHg regardless of their baseline IOP or an increase of >20 mmHg than the baseline IOP. We are expecting these events to happen in 25% of the eyes which will receive the slow injections.
Based on these event rates, a sample size of 32 eyes per group will be required for an 80% power of detecting a significant difference at the two-sided 5% level.

The primary outcome- IOP 2 minutes after injection compared to the pre-injection IOP will be analysed using the paired t-test.

The secondary outcome - IOP 15 minutes after injection will also be analysed using the paired t-test.

Data will be analysed on the basis of intention to treat.

Patient will be considered lost to follow up if he/she did not attend the second visit to receive the second injection.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287027 0
Self funded/Unfunded
Name [1] 287027 0
Country [1] 287027 0
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 285808 0
None
Name [1] 285808 0
Address [1] 285808 0
Country [1] 285808 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this study is to investigate the different impact of slow versus fast injection of the anti-VEGF agent, ranibizumab, which is the treatment participants are receiving for the treatment of age-related macular degeneration (AMD). The study will run for 4 months and involve 2 study visits. Participants will receive the intravitreal injection that they are already receiving for AMD. The IOP will be measured before the injection, 2 minutes after the injection and 15 minutes after the injection.

Study participants will be randomly assigned to two groups (group A and group B). Participants assigned to group A will receive their intravitreal injection as a quick push in the first visit and slowly (over 3-4 seconds) in the second visit. Participants assigned to group B will receive the opposite allocation. The two injections will be given 4-12 weeks apart according to the scheduled treatment for the participants AMD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39058 0
A/Prof Samantha Fraser-Bell
Address 39058 0
Save Sight Institute, The University of Sydney
South Block, Campus of Sydney Eye Hospital, 8 Macquarie St Sydney NSW, Australia, 2000
Country 39058 0
Australia
Phone 39058 0
+61-2-9382 7309
Fax 39058 0
Email 39058 0
sfraserbell@gmail.com
Contact person for public queries
Name 39059 0
Dr Wedad Salem
Address 39059 0
Save Sight Institute, The University of Sydney
South Block, Campus of Sydney Eye Hospital, 8 Macquarie St Sydney NSW, Australia, 2000
Country 39059 0
Australia
Phone 39059 0
+61-2-9382 7386
Fax 39059 0
Email 39059 0
wedad.salem@sydney.edu.au
Contact person for scientific queries
Name 39060 0
Dr Wedad Salem
Address 39060 0
Save Sight Institute, The University of Sydney
South Block, Campus of Sydney Eye Hospital, 8 Macquarie St Sydney NSW, Australia, 2000
Country 39060 0
Australia
Phone 39060 0
+61-2-9382 7386
Fax 39060 0
Email 39060 0
wedad.salem@sydney.edu.au

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.