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

the PLANET Investigators

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3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)80-89
Number of pages10
JournalAmerican journal of ophthalmology
Volume204
DOIs
Publication statusPublished - Aug 2019

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Safety
Photochemotherapy
aflibercept
Diabetic Retinopathy
Polyps
Visual Acuity
Therapeutics
Research Personnel
Injections

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

@article{cf3913eab054466191faf66069bb2c15,
title = "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.",
author = "{the PLANET Investigators} and Wong, {Tien Yin} and Yuichiro Ogura and Lee, {Won Ki} and Tomohiro Iida and Chen, {Shih Jen} and Paul Mitchell and {Gemmy Cheung}, {Chui Ming} and Zhongqi Zhang and S{\'e}rgio Leal and Tatsuro Ishibashi",
year = "2019",
month = "8",
doi = "10.1016/j.ajo.2019.02.027",
language = "English",
volume = "204",
pages = "80--89",
journal = "American Journal of Ophthalmology",
issn = "0002-9394",
publisher = "Elsevier USA",

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TY - JOUR

T1 - Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy

T2 - Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study

AU - the PLANET Investigators

AU - Wong, Tien Yin

AU - Ogura, Yuichiro

AU - Lee, Won Ki

AU - Iida, Tomohiro

AU - Chen, Shih Jen

AU - Mitchell, Paul

AU - Gemmy Cheung, Chui Ming

AU - Zhang, Zhongqi

AU - Leal, Sérgio

AU - Ishibashi, Tatsuro

PY - 2019/8

Y1 - 2019/8

N2 - 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.

AB - 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.

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