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. 2024 Jun 10;18:1701–1716. doi: 10.2147/OPTH.S464371

Table 2.

Summary of Select Clinical Trials of vPDT for the Treatment of Polypoidal Choroidal Vasculopathy

Study and Design Patient Population Treatments Efficacy Outcomes Safety Outcomes
vPDT combination therapy
EVEREST57
R, MC, DM, ph 4
Asia (7 sites)
N=61		 Pts with symptomatic macular PCV Ranibizumab 0.5 mg + vPDT
vPDT alone
Ranibizumab 0.5 mg alone		 Ranibizumab 0.5 mg + vPDT vs vPDT alone vs ranibizumab 0.5 mg alone
% pts with complete polyp regression at 6 mo: 77.8% (P=0.002 vs ranibizumab) vs 71.4% (P=0.004 vs ranibizumab) vs 28.6%		 Ranibizumab 0.5 mg + vPDT vs vPDT alone vs ranibizumab 0.5 mg alone
Ocular AEs: 26.3% vs 33.3% vs 19.0%
EVEREST II55
R, MC, DM, ph 4
24 mo
Asia (42 sites)
N=322		 Pts with symptomatic macular PCV
Tx-naïve		 Ranibizumab 0.5 mg with vPDT (combination tx; n=168) vs ranibizumab 0.5 mg with sham PDT (monotherapy; n=154)
IV injection on day 1 (baseline) and at 1 mo and 2 mo, followed by PRN regimen with ≥28 d between ranibizumab tx		 Combination vs monotherapy
Changes in BCVA during 24 mo

  • LS mean (SE) improvement from baseline at 24 mo: 9.6 (1.0) letters vs 5.5 (1.2) letters (between-group mean difference, 4.1 letters [95% CI, 1.0–7.2 letters]; 1-sided noninferiority, P<0.001, and superiority, P=0.005)


% of pts with complete polypoidal lesion regression (assessed by ICGA) at 24 mo and those with absence of leakage (assessed by FA) at 24 mo

  • ICGA: 81/143 (56.6%) vs 23/86 (26.7%; P<0.001)

  • FA: 84/146 (57.5%) vs 41/128 (32.0%)


Changes in central subfield thickness from baseline to 24 mo

  • Mean (SD) decrease from baseline: –152.9 (129.7) μm vs –109.3 (142.2) μm


Number of vPDT treatments received in study eye before 24 mo

  • Mean (SD) number: 2.2 (1.4) vs 3.7 (2.3)

 Combination vs monotherapy
Safety and tolerability of both treatments up to 24 mo

  • Ocular AEs: 64/172 (37.2%) vs 49/135 (36.3%)

  • Most common ocular SAE, vitreous hemorrhage: 0.6% vs 2.2%

  • Nonocular AEs: 94/172 (54.7%) vs 72/135 (53.3%)

  • Nonocular SAEs: 23/172 (13.4%) vs 18/135 (13.3%)


Mortality (all unrelated to study treatment): 2/172 (1.2%) vs 1/135 (0.7%)
PLANET56
R, MC, DM, ph 3b/4
62 sites: Asia (n=57), Germany (n=1), Hungary (n=4)
N=318 pts
Age: ≥50 y		 Pts with symptomatic macular PCV IV aflibercept 2 mg every 4 wk, at wks 0, 4, and 8 (run-in phase)
At wk 12, randomization into aflibercept plus rescue PDT (combination therapy) vs aflibercept plus sham PDT (monotherapy)		 Combination vs monotherapy
Change from baseline in BCVA (ETDRS letter score) for study eye at 52 wk (primary endpoint)

  • Mean (SD) gain in BCVA from baseline to 52 wk of >2 lines: 10.8 (10.7) vs 10.7 (11.3) (95% CI, –2.9 to 1.6; noninferior)


% of pts without moderate vision loss of ≥15 ETDRS letters from baseline to 52 wk (secondary endpoint)

  • 96.9% vs 97.5% (difference, 0.6; 95% CI, –3.1 to 4.3; P=0.74)

 Combination vs monotherapy
Safety at 52 wk

  • Ocular AEs: 47/161 (29.2%) vs 49/157 (31.2%)

  • Most common ocular AEs: dry eye (5.6%; combination therapy) and conjunctival hemorrhage (5.1%; monotherapy)

  • Ocular SAEs: 3.1% vs 0%

  • Nonocular AEs: 64/161 (39.8%) vs 74/157 (47.1%)
ATLANTIC54
R, DM, Sham-C, ph 4
Europe (14 sites)
N=50 (50 eyes)		 Caucasian pts with tx-naïve PCV IV aflibercept 2 mg T&E + vPDT (n=28)
IV aflibercept 2 mg T&E + sham PDT (n=28)
Monthly IV aflibercept at wk 0, 4, 8, then pts randomized at wk 16		 IV aflibercept 2 mg T&E + vPDT vs sham PDT
Change from baseline in BCVA to 52 wk

  • Median (IQR): 5 (2–13) vs 6.5 (2–11) letters (P=0.98)


Complete polyp occlusion at 52 wk: 68% vs 77% (P=0.5)		 IV aflibercept 2 mg T&E + vPDT vs sham PDT
Ocular AEs: 14% vs 32%

  • Related to aflibercept: 7% vs 0%

  • Related to PDT: 4% vs 0%


Ocular SAEs: 0% vs 0%
AE leading to discontinuation: 4% vs 0%

Abbreviations: AE, adverse event; BCVA, best-corrected visual acuity; CI, confidence interval; DM, double-masked; ETDRS, Early Treatment Diabetic Retinopathy Study; FA, fluorescein angiography; ICGA, indocyanine green angiography; IQR, interquartile range; IV, intravitreal; LS, least-squares; MC, multicenter; PCV, polypoidal choroidal vasculopathy; PDT, photodynamic therapy; Ph, phase; PLANET, Aflibercept in Polypoidal Choroidal Vasculopathy; PRN, pro re nata; pt, patient; R, randomized; SAE, serious adverse event; SD, standard deviation; SE, standard error; Sham-C, sham-controlled; T&E, treat and extend; tx, treatment; vPDT, verteporfin PDT.