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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
Scientific title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)
Secondary ID [1] 0 0
2014-004580-20
Secondary ID [2] 0 0
150998-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Stable Vision at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52
Timepoint [4] 0 0
Baseline to Week 52

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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2019
Sample size
Target
Accrual to date
Final
949
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Save Sight Institute, University of Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [3] 0 0
Sydney West Retina - Westmead
Recruitment hospital [4] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [5] 0 0
Specialist Eye Group - Glen Waverley
Recruitment hospital [6] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
Trial website
https://clinicaltrials.gov/study/NCT02462486
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Li
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02462486