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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02462486
Registration number
NCT02462486
Ethics application status
Date submitted
2/06/2015
Date registered
4/06/2015
Date last updated
30/07/2020
Titles & IDs
Public title
Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
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Scientific title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)
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Secondary ID [1]
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2014-004580-20
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Secondary ID [2]
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150998-006
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Universal Trial Number (UTN)
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Trial acronym
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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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Condition category
Condition code
Eye
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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
Treatment: Drugs - Abicipar Pegol
Treatment: Drugs - Ranibizumab
Other interventions - Sham Procedure
Experimental: Abicipar Pegol 2 mg (2Q8) - Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Experimental: Abicipar Pegol 2 mg (2Q12) - Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.
Active comparator: Ranibizumab (rQ4) - Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Treatment: Drugs: Abicipar Pegol
Abicipar pegol intravitreal injection.
Treatment: Drugs: Ranibizumab
Ranibizumab intravitreal injection.
Other interventions: Sham Procedure
Sham injection.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Percentage of Participants With Stable Vision at Week 52
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Assessment method [1]
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Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
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Timepoint [1]
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Baseline to Week 52
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Secondary outcome [1]
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Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52
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Assessment method [1]
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BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
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Timepoint [1]
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Baseline to Week 52
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Secondary outcome [2]
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Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
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Assessment method [2]
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CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.
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Timepoint [2]
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Baseline to Week 52
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Secondary outcome [3]
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Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52
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Assessment method [3]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
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Timepoint [3]
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Baseline to Week 52
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Secondary outcome [4]
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Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52
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Assessment method [4]
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NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
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Timepoint [4]
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Baseline to Week 52
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Eligibility
Key inclusion criteria
* Diagnosis of age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/40 to 20/320 in the study eye
* Best corrected visual acuity of 20/200 or better in the non-study eye
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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
* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months
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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 receiving the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
25/06/2015
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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
6/06/2019
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Sample size
Target
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Accrual to date
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Final
949
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Save Sight Institute, University of Sydney Eye Hospital - Sydney
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Sydney Retina Clinic and Day Surgery - Sydney
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Sydney West Retina - Westmead
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Centre for Eye Research Australia - East Melbourne
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Specialist Eye Group - Glen Waverley
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Lions Eye Institute - Nedlands
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2000 - Sydney
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2145 - Westmead
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3002 - East Melbourne
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3150 - Glen Waverley
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Ethics approval
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Summary
Brief summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
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Trial website
https://clinicaltrials.gov/study/NCT02462486
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Joanne Li
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Allergan
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/86/NCT02462486/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/86/NCT02462486/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02462486
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