A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abicipar Pegol — DRUG
  Abicipar pegol intravitreal injection.
• Ranibizumab — DRUG
  Ranibizumab intravitreal injection.
• Sham Procedure — OTHER
  Sham injection.

Study Details

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Key Dates

First listed

Jun 4, 2015

Start date

Jun 25, 2015

Status verified

Jul 2020

Primary completion

Apr 18, 2018

Completion

Jun 19, 2019

Study Design

Enrollment

939 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Abicipar Pegol 2 mg (2Q8)
  Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter 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, Week 12, and every 12 weeks (2Q12) thereafter 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 0.5 mg (rQ4)
  Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.

Primary Outcome Measure

Percentage of Participants With Stable Vision at Week 52 [ Time Frame: Baseline to Week 52 ]

Locations (71)

Find similar trials in Phoenix, AZ

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