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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02462486




Registration number
NCT02462486
Ethics application status
Date submitted
2/06/2015
Date registered
4/06/2015
Date last updated
24/07/2019

Titles & IDs
Public title
Safety and Efficacy of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Scientific title
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration
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 (group A) - Abicipar pegol 2 mg 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. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.

Experimental: abicipar pegol 2 mg (group B) - Abicipar pegol 2 mg 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. A sham procedure to the study eye will be performed every 4th week that an injection of abicipar pegol is not performed.

Active Comparator: ranibizumab - Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.


Treatment: Drugs: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.

Treatment: Drugs: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 96.

Other interventions: sham procedure
Sham procedure to the study eye at the visits noted per protocol.

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 Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline =15 Letters in the Study Eye
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Change from Baseline in BCVA in the Study Eye
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Percentage of Patients with a BCVA Gain of =15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score
Timepoint [4] 0 0
Baseline, 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [2] 0 0
Save Sight Institute, University of Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney West Retina Pty Ltd - Westmead
Recruitment hospital [4] 0 0
The Royal Victorian Eye & Ear Hospital, Center for Eye Research - 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
02000 - Sydney
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [6] 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 patients with neovascular
age-related macular degeneration.
Trial website
https://clinicaltrials.gov/show/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
Other publications