Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy: Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study.

Abstract

PURPOSE:

We sought to evaluate longer-term efficacy and safety of intravitreal aflibercept monotherapy (IAI) vs IAI plus rescue photodynamic therapy (rPDT) in patients with polypoidal choroidal vasculopathy (PCV).

DESIGN:

This was a prospective multicenter, double-masked, sham-controlled randomized clinical study across 62 centers.

METHODS:

In this phase 3b/4 study, patients with PCV with best-corrected visual acuity of 73-24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent) received IAI 2 mg every 4 weeks until week 12, when they were randomized 1:1 to receive IAI or IAI plus rPDT if rescue criteria were met. Patients not requiring rescue received IAI every 8 weeks; those requiring rescue received IAI every 4 weeks plus sham/active PDT. At week 52 (the primary endpoint), IAI was noninferior to IAI plus rPDT. After week 52, treatment intervals could be extended beyond 8 weeks at the investigators' discretion. Noninferiority of IAI vs IAI plus rPDT for mean best-corrected visual acuity change from baseline to week 96 was evaluated.

RESULTS:

Over 96 weeks, 54 patients (17.0%) met rescue criteria. At week 96, IAI was noninferior to IAI plus rPDT in terms of Early Treatment Diabetic Retinopathy Study letters gained (+10.7 vs +9.1, P = .48). Proportions of patients with complete polyp regression (33.1% vs 29.1%) or without active polyps (82.1% vs 85.6%) were similar. In year 2, the mean number of injections was 4.6 in both arms. No new safety signals were observed.

CONCLUSION:

IAI monotherapy was noninferior to IAI with rescue PDT up to 96 weeks, and functional and anatomical improvements achieved at 52 weeks were maintained. Few patients required rescue PDT, which provided no additional visual benefit.

• Authors: Tien Yin Wong, Yuichiro Ogura, Won Ki Lee, Tomohiro Iida, Shih-Jen Chen, Paul Mitchell, Chui Ming Gemmy Cheung, Zhongqi Zhang, Sérgio Leal, Tatsuro Ishibashi, PLANET Investigators
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 204 Pg. 80-89 (08 2019) ISSN: 1879-1891 [Electronic] United States
• PMID: 30849345 (Publication Type: Clinical Trial, Phase III, Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019. Published by Elsevier Inc.

Chemical References

• Photosensitizing Agents
• Recombinant Fusion Proteins
• aflibercept
• Receptors, Vascular Endothelial Growth Factor

Topics

• Aged
• Choroid (blood supply)
• Choroid Diseases (diagnosis, drug therapy)
• Double-Blind Method
• Female
• Fluorescein Angiography (methods)
• Follow-Up Studies
• Fundus Oculi
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Photochemotherapy (methods)
• Photosensitizing Agents (therapeutic use)
• Polyps (diagnosis, drug therapy)
• Prospective Studies
• Receptors, Vascular Endothelial Growth Factor (administration & dosage, antagonists & inhibitors)
• Recombinant Fusion Proteins (administration & dosage)
• Time Factors
• Tomography, Optical Coherence (methods)
• Treatment Outcome
• Visual Acuity