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Trial registered on ANZCTR
Registration number
ACTRN12622001246774p
Ethics application status
Submitted, not yet approved
Date submitted
7/09/2022
Date registered
15/09/2022
Date last updated
15/09/2022
Date data sharing statement initially provided
15/09/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Rapid Avastin (Bevacizumab) treatment and extension in low-risk age-related macular degeneration patients.
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Scientific title
Palmerston North Interventional Rapid Avastin Treat & Extend (PIRATE) study in low-risk age-related macular degeneration patients.
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Secondary ID [1]
307941
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Nil
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Universal Trial Number (UTN)
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Trial acronym
PIRATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
age-related macular degeneration
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Condition category
Condition code
Eye
324679
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In the PIRATE study we propose to investigate a modified treat and extend protocol. We will investigate extending treatment intervals by 4-weeks (treatment group) compared to the standard protocol of 2-weeks (control group).
Study population: Individuals with low-risk neovascular age-related macular generation (nAMD) (please see study protocol attached for specific low/high-risk stratification of nAMD).
Therapeutics: All participants will receive 0.05mL Bevacizumab (Avastin) 3.75mg/0.15mL administered as an intravitreal injection into the vitreous cavity of effected eye. These will be administered either by a qualified nurse injector or ophthalmology registrar/consultant.
Treatment frequency (treatment group): 3x Avastin at monthly intervals (induction), then treatment extension by 4 weeks if extension criteria meet (e.g. 8 weeks, 12 weeks, 16 weeks) until 16 weeks post-induction is reached (maximum treatment interval). If shortening criteria meet, then shortened by 4 weeks with each subsequent extensions will be at 2 weeks (as per standard protocol).
Treatment monitoring: each injection will be provided around a clinic appointment with optical coherence tomography (OCT) + clinical assessment. This will allow monitoring of treatment response or related adverse-effect. Strict shortening/extension/maintenance criteria has been established (please see study protocol attached for outlined criteria).
The term “rapid” corresponds to the treatment group’s 4-week treatment extension. Participants in this group will reach the 16 weeks maximal treatment interval in a minimum of 6 injections. The standard protocol (control group) in comparison takes a minimum of 9 injections. The treatment group has therefore a more “rapid” treatment extension as it requires fewer injections and therefore reaches the 16 weeks maximal extension "faster".
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Intervention code [1]
324396
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Treatment: Drugs
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Comparator / control treatment
In the PIRATE study we propose to investigate a modified treat and extend protocol. We will investigate extending treatment intervals by 4-weeks (treatment group) compared to the standard protocol of 2-weeks (control group).
Study population: Individuals with low-risk neovascular age-related macular generation (nAMD) (please see study protocol attached for specific low/high-risk stratification of nAMD).
Therapeutics: All participants will receive 0.05mL Bevacizumab (Avastin) 3.75mg/0.15mL administered as an intravitreal injection into the vitreous cavity of effected eye. These will be administered either by a qualified nurse injector or ophthalmology registrar/consultant.
Treatment frequency (control group): 3x Avastin at monthly intervals (induction), then treatment extension by 2 weeks if extension criteria meet (e.g. 6 weeks, 8 weeks, 10 weeks, 12 weeks, etc.) until 16 weeks post-induction (maximal treatment interval) is reached. Shortening and maintenance as per current protocol.
Treatment monitoring: each injection will be provided around a clinic appointment with optical coherence tomography (OCT) + clinical assessment. This will allow monitoring of treatment response or related adverse-effect. Strict shortening/extension/maintenance criteria has been established (please see study protocol attached for outlined criteria).
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Control group
Active
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Outcomes
Primary outcome [1]
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Best corrected visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) eye-chart equivalent.
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Assessment method [1]
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Timepoint [1]
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12 months post-intervention commencement
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Secondary outcome [1]
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Central macular thickness as defined by Zeiss Cirrus optical coherence tomography
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Assessment method [1]
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Timepoint [1]
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12 months post-intervention commencement
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Secondary outcome [2]
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Number of adverse injection-related events
(e.g. raised intraocular pressure, intraocular haemorrhage, retinal detachment, cataract formation, capsular tear, endophthalmitis). These will be determined by ophthalmology registrars/consultants involved in the study
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Assessment method [2]
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Timepoint [2]
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12 months post-intervention commencement
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Secondary outcome [3]
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Total number of injections
These will be determined by study investigators. A record will be kept of each injection on a secure data capture platform (REDCap). Total injection numbers will be assessed from the recorded data.
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Assessment method [3]
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Timepoint [3]
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12 months post-intervention commencement
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Secondary outcome [4]
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Whether treatment interval had to be shortened
Treatment interval would be shortened if any one of the following are met:
o New or persistent fluid with unchanged or increased fluid on OCT
o Loss of >5 EDTRs letters visual acuity
o Increase in CRT of >100 microns (in central 1mm region) compared to the lowest value measured on OCT
o New neovascularisation as determined by investigator
o New macular Haemorrhage
Please note that treatment interval decisions will be made by designated investigators by means of clinical review subsequent to treatments. This will be recorded in the secure research database; REDCAP.
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Assessment method [4]
413849
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Timepoint [4]
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12 months post-intervention commencement
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Secondary outcome [5]
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Number of large macular haemorrhages
As determined by investigator during dilated fundoscopic examination or using fundus photography
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Assessment method [5]
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Timepoint [5]
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12 months post-intervention commencement
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Secondary outcome [6]
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Total number of appointments of age-related macular degeneration appointments
These will be determined by study investigators. A record will be kept of each injection on a secure data capture platform (REDCap). Total injection numbers will be assessed from the recorded data.
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Assessment method [6]
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Timepoint [6]
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12 months post-intervention commencement
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Eligibility
Key inclusion criteria
•Patients greater than or equal to 50 years of age
•Low-risk nvAMD characteristics (see risk-stratification outlined below) with likely subfoveal or juxtafoveal choroidal neovascular membrane (CNVM). These being diagnosed clinically, confirmed by investigator (ophthalmology registrar or ophthalmologist)
•Deemed appropriate for Avastin therapy by investigator
•Best corrected visual acuity (BCVA) between 6/12 - 6/180 at first visit in study eye
•If both eyes affected then the eye with the worse BCVA will be included in the trial as the study eye
•Participants must be willing and able to provide independent informed consent
Participants with be stratified based on their nAMD characteristics. High-risk participants will be deemed anyone who meets one or more of the following criteria:
1. Monocular patients (i.e. only have a single good-seeing eye)
2. Macular haemorrhage (greater or equal to 1 disc diameter) clinically or on fundus photo
3. History of previous of large macular haemorrhage
4. Subretinal fluids (SRF) less than 200 microns
5. Recent reduction of injection frequency for any reason (i.e. if shortened by 4 weeks, then further extensions will be at 2 week intervals or ‘usual treatment’ as in control group)
High-risk participants will NOT be included in the PIRATE study cohort. They will continue with the current standard anti-VEGF therapy. Low-risk participants will be deemed anyone who meets the inclusion criteria WITHOUT having any of the high-risk criteria outlined.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
•Prior treatment of the study eye with intraocular anti-VEGF agents, verteporfin photodynamic therapy, other laser treatment, intraocular corticosteroids, surgical procedures (except cataract surgery greater than or equal to 30 days prior to screening)
•Systemic use of anti-VEGF agents within 3 months prior to the study entry period
•Active or suspected infection in or surrounding the study eye
•Peripapillary CNVM
•Active severe intraocular inflammation in the study eye
•Intraocular pressure greater than 28mmHg in study eye
•Ocular condition that might impact vision and confound study outcomes in the study eye (by the discretion of ophthalmology registrar or ophthalmologist)
•History of Avastin allergy or related intravitreal administration agents (e.g. povidone iodine, lidocaine, gutt. Iopidine, gutt. Chloramphenicol)
•Women who are pregnant, suspected to be pregnant or lactating
•Previous or concomitant participation in another clinical study with investigational medicinal product(s) within last 3 months
•Individuals who lack decision-making capacity who are not able to provide independent informed consent for the trial
•Any other patient deemed ineligible by investigator (ophthalmology registrar or ophthalmologist)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2022
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
25002
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New Zealand
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State/province [1]
25002
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Palmerston North Hospital
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Address [1]
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50 Ruahine Street, Roslyn, Palmerston North 4442
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Country [1]
312209
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New Zealand
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Primary sponsor type
Hospital
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Name
Palmerston North Hospital
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Address
50 Ruahine Street, Roslyn, Palmerston North 4442
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
313734
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committee (FULL pathway)
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Ethics committee address [1]
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Postal address: Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140 Street address: 133 Molesworth Street Thorndon Wellington 6011
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Ethics committee country [1]
311590
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New Zealand
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Date submitted for ethics approval [1]
311590
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01/09/2022
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Approval date [1]
311590
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Ethics approval number [1]
311590
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Summary
Brief summary
Age-related macular degeneration (AMD) is the primary cause of blindness of individuals over the age of 50 years in New Zealand. It is a lifelong chronic ocular condition requiring monitoring and treatment to prevent progression and irreversible visual loss. The prevalence of AMD is projected to increase by 20-40% over the next 10 years as a direct result of New Zealand’s aging population. With the current standardised treat and extend protocol (TAE), nAMD patients receive a loading dose of 3 Bevacizumab (Avastin) injections 4 weeks apart. The injection interval is then adjusted according to the level of disease activity. Patients with stable disease are extended by 2-week increments. For example; a patient receiving an Avastin injection every 4 weeks with stable disease activity would be subsequently extended to a 6-week injection interval. This would then be reassessed at the end of the 6-week treatment period to determine if it can be extended further to 8 weeks or requires to be reduced back to 4 weeks based on their disease activity (fluid-free status). Increment adjustments therefore only occurring at 2-week intervals. Injection frequency not only affects patients’ treatment burden but also leads to increasing demand on all aspects of ophthalmology service provision including; nurse-led injectors, macular review / hybrid clinic nurses, ophthalmology registrars and overseeing ophthalmologists. There are further constraints on physical space to perform injections and additional administrational work that accompanies intravitreal injection scheduling. Current practicing standards are unlikely to meet the projected increasing demand of nAMD patients expected over the next 10 years and therefore new innovative changes are required to current service provision. In the Palmerston North Interventional Rapid Avastin Treat & Extend (PIRATE) study we propose to investigate a modified treat and extend protocol. In the modified protocol, treatment adjustments would be in 4-week increments in patients with a low-risk nAMD. As an additional safety feature, any patient who require interval shortening or experience any adverse event from rapid treatment extension will have their interval immediately shortened by 4 weeks, with subsequent extension as per the current standard 2-week protocol. Each eligible patient will be informed of participation in the trial and may further opt-out of 4-week adjustments at any point if they so choose. Through this trial we hope to provide evidence to support rapid treatment extension of nAMD as a safe, efficient and practical method to adapt to our aging population and associated ophthalmic service constraints.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Antoine Bonnet
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Address
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Palmerston North Hospital
Ophthalmology Department
50 Ruahine Street, Roslyn, 4442,
Palmerston North,
New Zealand
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Country
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New Zealand
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Phone
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+64 0273947946
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Antoine Bonnet
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Address
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Palmerston North Hospital
Ophthalmology Department
50 Ruahine Street, Roslyn, 4442,
Palmerston North,
New Zealand
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Country
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New Zealand
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Phone
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+64 0273947946
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Antoine Bonnet
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Address
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Palmerston North Hospital
Ophthalmology Department
50 Ruahine Street, Roslyn, 4442,
Palmerston North,
New Zealand
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Country
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New Zealand
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Phone
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+64 0273947946
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
17096
Study protocol
384644-(Uploaded-11-09-2022-12-45-28)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Palmerston North Interventional Rapid Avastin Treat and Extend (PIRATE) study protocol; Meeting the medical retina service needs of our ageing population.
2023
https://dx.doi.org/10.1136/bmjophth-2022-001192
N.B. These documents automatically identified may not have been verified by the study sponsor.
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