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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01494805
Registration number
NCT01494805
Ethics application status
Date submitted
14/12/2011
Date registered
19/12/2011
Date last updated
1/09/2017
Titles & IDs
Public title
Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration
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Scientific title
A Phase I/II Controlled Dose-escalating Trial to Establish the Baseline Safety and Efficacy of a Single Subretinal Injection of rAAV.sFlt-1 Into Eyes of Patients With Exudative Age-related Macular Degeneration (AMD)
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Secondary ID [1]
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2008-135
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Universal Trial Number (UTN)
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Trial acronym
AMD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration
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Age-related Maculopathies
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Age-related Maculopathy
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Maculopathies,Age-related
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Maculopathy,Age-related
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Retinal Degeneration
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Retinal Neovascularization
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Eye Diseases
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - rAAV.sFlt-1
Other interventions - rAAV.sFlt-1
Other interventions - Control (ranibizumab alone)
Experimental: Low Dose rAAV.sFlt-1 -
Experimental: High Dose rAAV.sFlt-1 -
Active Comparator: Control - ranibizumab only -
Other interventions: rAAV.sFlt-1
1 x 10^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
Other interventions: rAAV.sFlt-1
1 x 10^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
Other interventions: Control (ranibizumab alone)
Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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No sign of unresolved ophthalmic complications, toxicity or systemic complications as measured by laboratory tests from 1 month post injection
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Assessment method [1]
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Ocular examination:
Ocular inflammation
Intraocular pressure
Visual acuity
Retinal bleeding
Abnormal laboratory data
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Timepoint [1]
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Primary endpoint at 1 month
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Secondary outcome [1]
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Maintenance or improvement of vision without the necessity of ranibizumab re-injections
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Assessment method [1]
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Best-corrected visual acuity
CNV lesion
Foveal thickness
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Timepoint [1]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Age greater than or equal to 55 years;
- Subfoveal CNV secondary to AMD and with best corrected visual acuity of 3/60 - 6/9
with 6/60 or better in the other eye;
- Fluorescein angiogram of the study eye must show evidence of a leaking subfoveal
choroidal neovascular lesion, or CNV currently under active management with anti-VEGF
therapy;
- Must be a candidate for anti-VEGF intravitreal injections;
- No previous retinal treatment of photodynamic therapy or laser;
- Able to provide informed consent;
- Able to comply with protocol requirements, including follow-up visits.
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Minimum age
55
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
- Liver enzymes > 2 X upper limit of normal;
- Any prior treatment for AMD in the study / control eye, excluding anti-VEGF
injections;
- Extensive sub-foveal scarring, extensive geographic atrophy, or thick subretinal blood
in the study eye as determined by the investigator;
- Significant retinal disease other than sub-foveal CNV AMD;
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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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
1/08/2017
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Lions Eye Institute - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lions Eye Institute, Perth, Western Australia
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Adverum Biotechnologies, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will involve approximately 40 subjects aged 55 or above who have exudative
age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two
doses of rAAV.sFlt-1 or assigned to the control group.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01494805
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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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Ian Constable, Professor
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Address
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Lions Eye Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01494805
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