Format

Send to

Choose Destination
J Ocul Pharmacol Ther. 2018 Nov 9. doi: 10.1089/jop.2018.0062. [Epub ahead of print]

Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration.

Author information

1
1 Texas Retina Associates , Arlington, Texas.
2
2 Retinal Consultants of Arizona , Phoenix, Arizona.
3
3 Midwest Eye Institute , Indianapolis, Indiana.
4
4 Department of Ophthalmology, Indiana University School of Medicine , Indianapolis, Indiana.
5
5 West Texas Retina , Abilene, Texas.
6
6 Department of Biomedical and Clinical Sciences, Eye Clinic, University of Milan , "Luigi Sacco" Hospital, Milan, Italy .
7
7 Department of Ophthalmology and Bern Photographic Reading Center, Inselspital, Bern University Hospital, University of Bern , Bern, Switzerland .
8
8 Allergan plc , Irvine, California.

Abstract

PURPOSE:

To evaluate safety and efficacy of the vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab for neovascular age-related macular degeneration.

METHODS:

Phase 2, multicenter, randomized, double-masked comparison (REACH study, stage 3). Patients (n = 64) received intravitreal injections of abicipar 1 mg or 2 mg at baseline, week 4, and week 8 (3 injections) or ranibizumab 0.5 mg at baseline and monthly (5 injections).

RESULTS:

In the abicipar 1 mg (n = 25), abicipar 2 mg (n = 23), and ranibizumab (n = 16) arms, respectively, least-squares mean best-corrected visual acuity (BCVA) change from baseline was +6.2, +8.3, and +5.6 letters at week 16 (primary endpoint) and +8.2, +10.0, and +5.3 letters at week 20. Least-squares mean central retinal thickness (CRT) reduction from baseline was 134, 113, and 131 μm at week 16 and 116, 103, and 138 μm at week 20. Intraocular inflammation adverse events (AEs), reported in 5/48 (10.4%) abicipar-treated patients, resolved without sustained vision loss or other sequelae.

CONCLUSIONS:

Abicipar demonstrated durability of effect: BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection). No serious AEs were reported.

KEYWORDS:

abicipar pegol; age-related macular degeneration; anti-VEGF; choroidal neovascularization; optical coherence tomography; vascular endothelial growth factor

PMID:
30412448
DOI:
10.1089/jop.2018.0062
Free full text

Supplemental Content

Full text links

Icon for Atypon Icon for Bern Open Repository and Information System
Loading ...
Support Center