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Association between pachychoroid and long-term treatment outcomes of photodynamic therapy with intravitreal ranibizumab for polypoidal choroidal vasculopathy.

ABSTRACT: We investigated long-term treatment responses in patients with treatment-naïve polypoidal choroidal vasculopathy (PCV) undergoing photodynamic therapy (PDT) with intravitreal ranibizumab (IVR). The medical charts of 14 patients with treatment-naïve PCV who underwent PDT with IVR were retrospectively reviewed. Patients were followed up and treated with additional IVR for ≥3 years. Best-corrected visual acuity (BCVA), central foveal thickness (CFT), greatest linear dimension (GLD) on angiography, polyp regression and central choroidal thickness (CCT) were assessed. Associations between these functional or anatomic outcomes with age, baseline CCT, baseline GLD or choroidal vascular hyperpermeability (CVH) were investigated using univariate and multivariate analysis. Mean logMAR BCVA improved significantly at 3 years (0.34 ± 0.24 to 0.12 ± 0.29, p = 0.003). Greater BCVA improvement and longer time to first recurrence was significantly associated with CVH. Fewer number of IVR retreatment within 3 years was associated with thicker baseline CCT. Mean CCT significantly decreased at 3 years (217 ± 33 µm to 197 ± 48 µm, p = 0.003). Greater decrease of CCT was significantly associated both with greater number of IVR retreatment within 3 years and absence of CVH. These results showed that pachychoroid characteristics at baseline was associated long-term functional and anatomic outcomes in patients with treatment-naïve PCV who had undergone combination PDT and IVR.

SUBMITTER: Azuma K

PROVIDER: S-EPMC7239911 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceThe EVEREST II trial showed that for patients with polypoidal choroidal vasculopathy (PCV), intravitreal ranibizumab in combination with verteporfin photodynamic therapy improves visual acuity relative to ranibizumab monotherapy. However, whether combination therapy is incrementally cost-effective relative to monotherapy during a lifetime is unclear.ObjectiveTo assess the incremental cost-effectiveness of combination therapy compared with ranibizumab monotherapy in patients with PCV.Design, setting, and participantsThis model-based, economic evaluation used 2018 unit cost data from a tertiary eye hospital in Singapore, first- and second-year outcomes and resource use data from a multicenter trial across various Asian countries (EVEREST II) to model a hypothetical cohort of patients with symptomatic PCV. Scenario analyses and deterministic and probabilistic sensitivity analyses were performed to examine uncertainty. Data were collected from October 2018 through April 2019 and analyzed from March through October 2019.InterventionsThis model used data from the EVEREST II trial, in which all participants were given 0.5 mg of intravitreal ranibizumab once every 4 weeks for the first 3 months. Subsequent administration occurred as needed. For participants receiving combination therapy, standard fluence (50 J/cm3) photodynamic therapy with 6-mg/m2 verteporfin was administered once during the first 3 months and thereafter as needed.Main outcomes and measuresIncremental cost per quality-adjusted life-year (QALY) gained for combination therapy relative to monotherapy for patients with PCV.ResultsIn this model based on a cohort of 1000 patients aged 68 years, a patient with PCV incurred a total cost in Singapore dollars (SGD) of 92 327 (US $67 399) with combination therapy and SGD 92 371 (US $67 431) with monotherapy during a lifetime horizon, generating a modest cost savings of SGD 44 (US $32) per patient undergoing combination therapy. Lifetime QALYs were estimated to be 7.87 for combination therapy and 7.85 for monotherapy, for an incremental gain of 0.02 QALYs. Combination therapy remained cost-saving or cost-effective in all lifetime scenarios modeled, but during shorter time horizons and at lower monotherapy costs, it may not be cost-effective.Conclusions and relevanceThis study found combination therapy to be a dominant (more effective and less costly) strategy, being similar in costs and slightly more effective than ranibizumab monotherapy during a lifetime horizon. However, decreasing the time horizon to less than 10 years and/or reductions in the cost of monotherapy may result in combination therapy no longer being cost-effective.

Project description:The optimal treatment for polypoidal choroidal vasculopathy (PCV) is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study was to compare the outcomes of photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1?+?PRN" treatment regimen for PCV.Fifty-seven eyes of 57 patients completed the 12 months' follow-up in this prospective study. The patients in the PDT arm(n?=?23), ranibizumab arm(n?=?18), or combination arm(n?=?16) underwent a session of PDT, IVR or combination of both at baseline followed by additional IVR as needed. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT) and the regression rate of polyps were evaluated. Cost-benefit analysis was also performed.At Month 12, the mean logMAR VA improved from 0.90?±?0.52 to 0.75?±?0.57 in the PDT group (P?<?0.05), from 0.96?±?0.58 to 0.77?±?0.41 in the IVR group (P?<?0.05), and from 0.94?±?0.55 to 0.72?±?0.44 in the combination group (P?<?0.05), respectively. The CFT decreased from 478.04?±?156.70 ?m, 527.5?±?195.90 ?m, and 522.63?±?288.40 ?m at the baseline to 366.43?±?148.28 ?m, 373.17?±?134.88 ?m and 328.44?±?103.25 in the PDT group (P?<?0.05), IVR group (P?<?0.01), and the combination group (P?<?0.05), respectively. However, no statistical difference was found between groups (P?>?0.05). PDT treatment (60.87%) was superior to the IVR therapy (22.22%) in achieving complete regression of polyps (P?<?0.05). Cost-benefit analysis showed that IVR treatment cost the least money for improving per 0.1logMAR units and the combination therapy demanded the least money for reducing per 100 ?m of CFT.PDT, IVR and the combination therapy have similar efficacy in the VA improvement as well as the reduction of CFT under the "1?+?PRN" treatment regimen.Current Controlled Trials NCT03459144 . Registered retrospectively on March 2, 2018.

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Association between pachychoroid and long-term treatment outcomes of photodynamic therapy with intravitreal ranibizumab for polypoidal choroidal vasculopathy.

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