Aflibercept in Polypoidal Choroidal Vasculopathy

• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug): Eylea is administered as an intravitreal injection
• Visudyne (Other): Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Primary outcomes

• Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) [From Baseline to Week 52]: Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.

Secondary outcomes

• Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 [At Week 52]: Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.

Other outcomes

• Percentage of Subjects Who Never Need Rescue Therapy in the First Year [Baseline to Week 52]: Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
• Number of PDT Treatments in the Study Eye Before Week 52 [Baseline to Week 52]
• Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 [Baseline to Week 52]
• Time to First Administration of PDT in the Study Eye Before Week 52 [Baseline to Week 52]
• Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye [Baseline to Week 52]: Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
• Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 [Baseline to Week 52]: Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
• Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 [Baseline to Week 52]: Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
• Percentage of Subjects With Complete Polyp Regression at Week 52 [Baseline to Week 52]: Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.
• Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52 [Baseline to Week 52]: Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.
• Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52 [Baseline to Week 52]: Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).
• Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52 [Baseline to Week 52]: The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
• Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52 [Baseline to Week 52]: Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.

Sex: All, ages: 50 Years to any

Inclusion Criteria:

* Signed informed consent
* Men and women ≥50 years of age
* Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center
* Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA.
* An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.

Exclusion Criteria:

* Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry
* Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry
* Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)
* History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green.
* History of allergy to aflibercept, verteporfin, or their excipients.

Participant flow

Outcome results

• Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) (Primary), Mean, Letters correctly read: Aflibercept + Sham Photodynamic Therapy (PDT) 10.7 +/- 11.3; Aflibercept + Active PDT 10.8 +/- 10.7 (p 0.5480)
• Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 (Secondary), Number, Percentage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 97.5; Aflibercept + Active PDT 96.9 (p 0.7402)
• Percentage of Subjects Who Never Need Rescue Therapy in the First Year (Other pre specified), Number, Percentage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 87.9; Aflibercept + Active PDT 85.7
• Number of PDT Treatments in the Study Eye Before Week 52 (Other pre specified), Mean, PDT administrations: Aflibercept + Sham Photodynamic Therapy (PDT) 0.2 +/- 0.7; Aflibercept + Active PDT 0.2 +/- 0.4 (p 0.0682)
• Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 (Other pre specified), Mean, Aflibercept injections: Aflibercept + Sham Photodynamic Therapy (PDT) 5.2 +/- 1.1; Aflibercept + Active PDT 5.1 +/- 0.8 (p 0.1640)
• Time to First Administration of PDT in the Study Eye Before Week 52 (Other pre specified), Mean, Days: Aflibercept + Sham Photodynamic Therapy (PDT) 131.2 (80 to 278); Aflibercept + Active PDT 128.2 (80 to 315)
• Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye (Other pre specified), Mean, Letters: Aflibercept + Sham Photodynamic Therapy (PDT) 10.7 +/- 11.3; Aflibercept + Active PDT 10.8 +/- 10.7
• Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 (Other pre specified), Number, Percentage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 73.9; Aflibercept + Active PDT 78.9 (p 0.2348)
• Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 (Other pre specified), Number, Percentage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 7.0; Aflibercept + Active PDT 5.6 (p 0.5372)
• Percentage of Subjects With Complete Polyp Regression at Week 52 (Other pre specified), Number, Percetage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 38.9; Aflibercept + Active PDT 44.8 (p 0.3244)
• Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52 (Other pre specified), Mean, Square millimeter: Aflibercept + Sham Photodynamic Therapy (PDT) -1.3 +/- 3.6; Aflibercept + Active PDT -1.2 +/- 3.7 (p 0.7109)
• Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52 (Other pre specified), Mean, Millimeter: Aflibercept + Sham Photodynamic Therapy (PDT) -137.7 +/- 116.0; Aflibercept + Active PDT -143.5 +/- 110.5 (p 0.8355)
• Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52 (Other pre specified), Mean, Scores on a scale: Aflibercept + Sham Photodynamic Therapy (PDT) 4.7 +/- 10.3; Aflibercept + Active PDT 7.3 +/- 12.5 (p 0.5069)
• Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52 (Other pre specified), Number, Percentage of subjects: Aflibercept + Sham Photodynamic Therapy (PDT) 12.1; Aflibercept + Active PDT 14.3 (p 0.8423)

Adverse events

Time frame: From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.

Serious adverse events by term

6 more terms not shown.

Other adverse events by term

• Results publication: Teo KYC, Yoon YH, Honda S, Park KH, Takahashi H, Ideta R, Sekiryu T, Hirata A, Obana A, Mori R, Chen SJ, Chee C, Wong JG, Lai TYY, Wong I, Fung N, Lee WK, Terasaki H, Chen SC, Miyatani T, Iida T, Obata R, Machewitz T, Leal S, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the PLANET Study. Ophthalmol Ther. 2026 Jun;15(6):1907-1924. doi: 10.1007/s40123-026-01366-5. Epub 2026 Mar 28. PMID 41903075
• Results publication: Lee WK, Iida T, Ogura Y, Chen SJ, Wong TY, Mitchell P, Cheung GCM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):786-793. doi: 10.1001/jamaophthalmol.2018.1804. PMID 29801063

• Bayer Study Director, Study director, Bayer