Phase 4
Completed N=333
Aflibercept in Polypoidal Choroidal Vasculopathy
Neovascular Macular Degeneration
Source: ClinicalTrials.gov NCT02120950 ↗
Enrolled (actual)
333
Serious AEs
16.8%
Results posted
Jan 2019
Primary outcomePrimary: 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) — 10.7; 10.8 Letters correctly read — p=0.5480
◆ Published Evidence
Highly cited
267citations · ~33 / year
Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study: A Randomized Clinical Trial.
Summary
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration
Linked Publications (2)
-
Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study: A Randomized Clinical Trial.
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Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the PLANET Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
10.7; 10.8 | 0.5480 |
| SECONDARY Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 |
97.5; 96.9 | 0.7402 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02120950) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.