Phase 2 N=123 Treatment

A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT03539549 ↗

Enrolled (actual)

123

Serious AEs

13.0%

Results posted

Aug 2020

Primary outcome: Primary: Percentage of Participants With Stable Vision — 97.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Abicipar pegol (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Stable Vision	97.6	—
SECONDARY Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	-82.5	—
SECONDARY Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye	0.9	—
SECONDARY Change Form Baseline in BCVA in the Study Eye	3.6	—
SECONDARY Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye	9.8	—

Summary

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Eligibility Criteria

Inclusion Criteria

Male or female participants, 50 years of age or older at the time of informed consent
Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Exclusion Criteria

Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
Previous or concurrent macular laser treatment (study eye)
Cataract or refractive surgery within 3 months prior to baseline (study eye)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03539549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.