Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration.

Abstract

PURPOSE:

To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).

DESIGN:

Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data.

PARTICIPANTS:

The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to age-related macular degeneration and best-corrected visual acuity (BCVA) of 24 to 73 Early Treatment Diabetic Retinopathy Study letters.

METHODS:

At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630).

MAIN OUTCOME MEASURES:

Efficacy measures included stable vision (<15-letter loss in BCVA from baseline) and change from baseline in BCVA and central retinal thickness (CRT). Safety measures included adverse events (AEs).

RESULTS:

For patients who completed the study, efficacy of abicipar after initial doses was maintained through week 104. At week 104, the proportion of patients with stable vision was 93.0% (396/426), 89.8% (379/422), and 94.4% (470/498); mean change in BCVA from baseline was +7.8 letters, +6.1 letters, and +8.5 letters, and mean change in CRT from baseline was -147 μm, -146 μm, and -142 μm in the abicipar Q8 (14 injections), abicipar Q12 (10 injections), and ranibizumab Q4 (25 injections) groups, respectively. The overall incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3% from baseline through week 52 and 16.2%, 17.6%, and 1.3% from baseline through week 104 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively.

CONCLUSIONS:

Two-year results show efficacy of abicipar Q8 and Q12 in nAMD. First onset of IOI events with abicipar was much reduced in the second year and comparable with ranibizumab (0.8% and 2.3% vs. 1.0%). The extended duration of effect of abicipar allows for quarterly dosing and reduced treatment burden.

• Authors: Rahul N Khurana, Derek Kunimoto, Young Hee Yoon, Charles C Wykoff, Andrew Chang, Raj K Maturi, Hansjürgen Agostini, Eric Souied, David R Chow, Andrew J Lotery, Masahito Ohji, Francesco Bandello, Rubens Belfort Jr, Xiao-Yan Li, Jenny Jiao, Grace Le, Kimmie Kim, Werner Schmidt, Yehia Hashad, CEDAR and SEQUOIA Study Groups
• Journal: Ophthalmology (Ophthalmology) Vol. 128 Issue 7 Pg. 1027-1038 (07 2021) ISSN: 1549-4713 [Electronic] United States
• PMID: 33221326 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Recombinant Fusion Proteins
• abicipar pegol

Topics

• Aged
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Intravitreal Injections
• Macula Lutea (pathology)
• Male
• Recombinant Fusion Proteins (administration & dosage)
• Time Factors
• Tomography, Optical Coherence (methods)
• Treatment Outcome
• Visual Acuity
• Wet Macular Degeneration (diagnosis, drug therapy)