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

Callanan, David; Kunimoto, Derek; Maturi, Raj K; Patel, Sunil S; Staurenghi, Giovanni; Wolf, Sebastian; Cheetham, Janet K; Hohman, Thomas C; Kim, Kimmie; López, Francisco J; Schneider, Susan (2018). Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. (In Press). Journal of ocular pharmacology and therapeutics Mary Ann Liebert 10.1089/jop.2018.0062

[img]
Preview
Text
jop.2018.0062.pdf - Published Version
Available under License Creative Commons: Attribution (CC-BY).

Download (402kB) | Preview

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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology

UniBE Contributor:

Wolf, Sebastian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1080-7683

Publisher:

Mary Ann Liebert

Language:

English

Submitter:

Sebastian Wolf

Date Deposited:

28 Nov 2018 12:50

Last Modified:

28 Nov 2018 17:11

Publisher DOI:

10.1089/jop.2018.0062

PubMed ID:

30412448

Uncontrolled Keywords:

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

BORIS DOI:

10.7892/boris.121535

URI:

https://boris.unibe.ch/id/eprint/121535

Actions (login required)

Edit item Edit item
Provide Feedback