A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration

Study Overview
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Brief Summary
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This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: abicipar pegol
* Drug: ranibizumab
* Other: sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ethnically Japanese Diagnosis of wet age-related macular degeneration in at least 1 eye Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye Exclusion Criteria: Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish Cataract or refractive surgery within the last 3 months History of vitrectomy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abicipar pegol 2 mg<br>Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. | Drug: abicipar pegol<br>* Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.<br>Other: sham procedure<br>* Sham procedure to the study eye at weeks 12 and 16.<br>|
| Experimental: abicipar pegol 1 mg<br>Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. | Drug: abicipar pegol<br>* Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.<br>Other: sham procedure<br>* Sham procedure to the study eye at weeks 12 and 16.<br>|
| Active Comparator: ranibizumab 0.5 mg<br>Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. | Drug: ranibizumab<br>* Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.<br>* Other names: Lucentis®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened. | Baseline, Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in BCVA in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened. | Baseline, Week 20 | 
| Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | 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 patients with a BCVA gain of ≥15 letters are noted. | Baseline, 20 Weeks | 
| Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale | 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 patients with a BCVA gain of ≥10 letters are noted. | Baseline, 20 Weeks | 
| Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | CRT is 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. | Baseline, Week 16, Week 20 |