Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
Summary
This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
Timeline
- Start
- 2013-08-07
- Primary completion
- 2016-03-11
- Completion
- 2017-03-02
Outcome
Met primary endpoint
registry analysis (non-inferiority test); Ranibizumab 0.5 mg + vPDT vs Ranibizumab 0.5 mg; p <0.001; Least Squares Mean 3.2; ANCOVA NCT01846273 ↗
registry analysis (superiority test); Ranibizumab 0.5 mg + vPDT vs Ranibizumab 0.5 mg; p <0.0001; Fisher Exact NCT01846273 ↗
paper At 12 months, mean improvement from baseline was 8.3 letters with combination therapy vs 5.1 letters with monotherapy PMID 28983556 ↗
paper Combination therapy was also superior to monotherapy in achieving complete polyp regression at month 12 (69.3% vs 34.7%; P < .001). PMID 28983556 ↗
Publications
- Yanagi Y, Mori R, Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Lai TYY, Cheung G, Honda S. Six-year findings of polypoidal choroidal vasculopathy in the EVEREST II study: Japanese subgroup analysis. Jpn J Ophthalmol. 2025 Nov;69(6):894-901. doi: 10.1007/s10384-025-01228-w. Epub 2025 Jun 12.
- Teo KYC, Park KH, Ngah NF, Chen SJ, Ruamviboonsuk P, Mori R, Kondo N, Lee WK, Rajagopalan R, Obata R, Wong IYH, Chee C, Terasaki H, Sekiryu T, Chen SC, Yanagi Y, Honda S, Lai TYY, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the EVEREST II Study. Ophthalmol Ther. 2024 Apr;13(4):935-954. doi: 10.1007/s40123-024-00888-0. Epub 2024 Feb 3.
- Lim TH, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Lee WK, Cheung CMG, Ngah NF, Patalauskaite R, Margaron P, Koh A; EVEREST II Study Group. Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):935-942. doi: 10.1001/jamaophthalmol.2020.2443.
- Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |
| Subject | Verteporfin | Other / unclassified | 30 ml | — |