Abstract
PurposeTo compare the efficacy of initial vs. delayed photodynamic therapy (PDT) in combination with intravitreal injection of conbercept (IVC) for polypoidal choroidal vasculopathy (PCV).DesignMulticenter, randomized, non-inferiority clinical trial.SubjectsNaïve PCV patients.MethodsPatients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. At baseline, patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group.Main Outcome MeasuresNon-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above −5 letters).ResultsEighty-six patients were enrolled, with 43 in each group. At month 12, the change of BCVA in initial combination group was equivalent to that in the delayed combination group, with gains of 6.42 ± 1.89 and 7.49 ± 2.14 (mean ± standard error) letters, respectively [delayed group minus initial group: 1.07 letters; 95% confidence interval (CI): −4.62 to 6.76; Pnon−inferiority = 0.0198]. The rates of complete polyp regression were 66.67 and 45.83% in the initial and delayed combination groups, respectively. The difference was not statistically significant (P = 0.386). The mean reductions of CRT were 204.77 ± 28.79 and 84.14 ± 30.62 μm in each group respectively. The difference was statistically significant (P = 0.005). In addition, the mean injection numbers were 3.47 ± 2.39 and 4.91 ± 2.65 in each group respectively. The differences were statistically significant (P = 0.010).ConclusionsThere was effective in both groups in patients with PCV. The initial combination group showed a more efficient decrease in CRT and polyp regression, along with fewer injections. However, the delayed combination group was non-inferior compared with the initial combination group in terms of the improvement of BCVA.Trial Registrationhttps://ClinicalTrials.gov, Identifier: NCT02821520.
Highlights
Age-related macular degeneration (AMD) is the leading cause of blindness worldwide and is expected to affect 170 million people by 2040, including 110 million people in Asia alone [1,2,3]
Rescue IVC treatment criteria included new or persistent subretinal/inner fluid detected by OCT; central retinal thickness (CRT) increase≥50 μm compared with the last visit; best-corrected visual acuity (BCVA) decrease ≥ 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with the last visit; or active leakage of polypoidal lesions detected by indocyanine green angiography (ICGA)
Rescue photodynamic therapy (PDT) treatment criteria included an increase of central retinal thickness (CRT) by ≥50 μm compared with that at baseline; new or enlarged polyps, or branching vascular network (BVN) detected by ICGA
Summary
Patients were randomized 1:1 into two groups: initial PDT with IVC and delayed PDT with IVC. Patients in the initial combination group were treated with PDT and IVC within 1 week, while patients in the delayed combination group were treated with IVC alone. PDT and IVC was given PRN during the follow-up in each group. Main Outcome Measures: Non-inferiority of delayed PDT with IVC to initial PDT with IVC for mean change in best-corrected visual acuity from baseline to month 12 (95% CI of the difference entirely above −5 letters)
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