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Introduction <p>The PLANET study demonstrated that intravitreal aflibercept 2&#xa0;mg injection (IAI) monotherapy was non-inferior to IAI with rescue photodynamic therapy (PDT) for polypoidal choroidal vasculopathy (PCV) at 2&#xa0;years. This follow-up study assessed the long-term outcomes 6&#xa0;years after initiation of IAI therapy in the PLANET cohort.</p> Methods <p>This was a non-interventional cohort study of 72 patients with PCV from six international sites who originally completed the PLANET study. Outcomes were assessed during a recall visit at ~6&#xa0;years from PLANET enrollment. Data collected included best-corrected visual acuity (BCVA), optical coherence tomography, treatment exposure, and adverse events. Patients were treated according to standard of care after exiting from the PLANET study.</p> Results <p>Of 72 participants, 32 were randomized to IAI monotherapy and 40 to IAI with rescue PDT. Of those randomized to IAI with rescue PDT, 11 (15.2%) received rescue PDT during the entire study period over 6&#xa0;years. Mean ± standard deviation (SD) BCVA improved by 14.6 ± 10.3 letters at 2&#xa0;years but declined to baseline by 6&#xa0;years (−0.3 ± 21.8 letters). At year 6, 45.8% of eyes had BCVA ≥ 69 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, while 23.6% had &lt; 36 ETDRS letters. Polypoidal lesions were present in 69.4% at year 2 versus 29.2% at year 6. Patients received a mean ± SD of 10.2 ± 2.9 anti-vascular endothelial growth factor (anti-VEGF) injections between years 2–6. Outcomes were better in reimbursed versus non-reimbursed regions. Multivariable analysis showed that younger age and better mean BCVA at year 2 predicted more favorable long-term vision. PDT received at any time was not associated with overall mean BCVA at year 6, although it was associated with a lower risk of ≥ 15-letter loss.</p> Conclusion <p>At 6&#xa0;years, initial visual gains from aflibercept therapy were not maintained; however, nearly half of the eyes had BCVA ≥ 69 letters, and a large proportion achieved polypoidal lesion regression.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT002120950.</p>

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Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the PLANET Study

  • 期刊论文

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  • 发表日期：

    2026年3月28日

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  • Kelvin Yi Chong Teo,
  • Young Hee Yoon,
  • Shigeru Honda,
  • Kyu Hyung Park,
  • Hidenori Takahashi,
  • Ryuichi Ideta,
  • Tetsuju Sekiryu,
  • Akira Hirata,
  • Akira Obana,
  • Ryusaburo Mori,
  • Shih-Jen Chen,
  • Caroline Chee,
  • James G. Wong,
  • Timothy Y. Y. Lai,
  • Ian Wong,
  • Nick Fung,
  • Won Ki Lee,
  • Hiroko Terasaki,
  • Shih-Chou Chen,
  • Takafumi Miyatani,
  • Tomohiro Iida,
  • Ryo Obata,
  • Tobias Machewitz,
  • Sergio Leal,
  • Chui ming Gemmy Cheung

摘要

Introduction

The PLANET study demonstrated that intravitreal aflibercept 2 mg injection (IAI) monotherapy was non-inferior to IAI with rescue photodynamic therapy (PDT) for polypoidal choroidal vasculopathy (PCV) at 2 years. This follow-up study assessed the long-term outcomes 6 years after initiation of IAI therapy in the PLANET cohort.

Methods

This was a non-interventional cohort study of 72 patients with PCV from six international sites who originally completed the PLANET study. Outcomes were assessed during a recall visit at ~6 years from PLANET enrollment. Data collected included best-corrected visual acuity (BCVA), optical coherence tomography, treatment exposure, and adverse events. Patients were treated according to standard of care after exiting from the PLANET study.

Results

Of 72 participants, 32 were randomized to IAI monotherapy and 40 to IAI with rescue PDT. Of those randomized to IAI with rescue PDT, 11 (15.2%) received rescue PDT during the entire study period over 6 years. Mean ± standard deviation (SD) BCVA improved by 14.6 ± 10.3 letters at 2 years but declined to baseline by 6 years (−0.3 ± 21.8 letters). At year 6, 45.8% of eyes had BCVA ≥ 69 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, while 23.6% had < 36 ETDRS letters. Polypoidal lesions were present in 69.4% at year 2 versus 29.2% at year 6. Patients received a mean ± SD of 10.2 ± 2.9 anti-vascular endothelial growth factor (anti-VEGF) injections between years 2–6. Outcomes were better in reimbursed versus non-reimbursed regions. Multivariable analysis showed that younger age and better mean BCVA at year 2 predicted more favorable long-term vision. PDT received at any time was not associated with overall mean BCVA at year 6, although it was associated with a lower risk of ≥ 15-letter loss.

Conclusion

At 6 years, initial visual gains from aflibercept therapy were not maintained; however, nearly half of the eyes had BCVA ≥ 69 letters, and a large proportion achieved polypoidal lesion regression.

Trial Registration

ClinicalTrials.gov identifier, NCT002120950.