One year outcomes of treat and extend and pro re nata (PRN) treatment regimens with aflibercept for polypoidal choroidal vasculopathy

Abstract

Purpose: To compare the 1-year outcomes of treat-and-extend and pro re nata (PRN) treatment regimens with aflibercept for polypoidal choroidal vasculopathy (PCV), by the means of visual acuity (VA), frequency of recurrence of polypoidal lesions and developed fibrosis, and the number of intravitreal injections, and thus to determine which one is preferable in the maintenance phase in PCV. Methods: In our prospective study, only naive and previously untreated PCV patients were included. Initially one session of photodynamic therapy (PDT) and three monthly intravitreal injections of 2.0 mg aflibercept (IAIs) were applied in 38 eyes. After this loading phase, they were re-examined and 30 PCV eyes with no exudative phenomena were included in the study. They were divided in two groups; in the first one (16 patients) the PRN treatment modality of IAIs was applied, while in the second one (14 patients) the treat-and-extend regimen was applied. Results: Over a 12-month period, VA significantly improved in treat-and-extend group (logMAR BCVA 0.41 ± 0.15 vs 0.57 ± 0.24 at baseline, p = 0.044), while in the PRN group VA remained stable (logMAR BCVA 0.70 ± 0.36 vs 0.65 ± 0.18 at baseline, p = 0.61). During the maintenance phase, the patients of treat-and-extend group did not encounter development/progression of fibrosis or any recurrent episodes, whereas the patients of PRN group had significantly more recurrent episodes (0 vs 1.37 ± 0.5, p < 0.001) and the frequency of development/progression of fibrosis was significantly higher (0% vs 44%, p = 0.02). However, the treat-and-extend treatment regimen was accompanied by significantly more administered IAIs (6 ± 0 vs 5.13 ± 1.08, p = 0.006). Conclusion: We highlighted the superiority of treat-and-extend regime with IAIs, which seems to yield better functional outcomes by preventing recurrence and subfoveal fibrosis, although a greater number of injections is required.

Anti-Vascular Endothelial Growth Factor Therapy Regimens for Polypoidal Choroidal Vasculopathy: A Systematic Review

“…The outcomes described herein were reported across at least two included studies over a follow-up period of 1 year. The mean BCVA at 12 months was 0.39 ± 0.41 logMAR (∼20/50 Snellen, n = 43 eyes; 3 studies) across study arms administering anti-VEGF agents using a PRN regimen [10, 19, 21], 0.41 ± 0.30 logMAR (∼20/50 Snellen, n = 144 eyes, 3 studies) across arms using a T&E regimen [10, 17, 18], and 0.17 ± 0.28 logMAR (∼20/32 Snellen, n = 61 eyes, 3 studies) across arms using a fixed bimonthly regimen [17, 19, 21]. The mean improvement in BCVA from baseline was 0.08 ± 0.25 logMAR (mean follow-up = 12 months, n = 33 eyes, 2 studies) across study arms administering anti-VEGF agents using a PRN regimen [10, 19], 0.15 ± 0.26 logMAR (mean follow-up = 11.5 months, n = 270 eyes, 4 studies) across arms using a T&E regimen [10, 17, 18, 20], and 0.15 ± 0.21 logMAR (mean follow-up = 12 months, n = 38 eyes, 2 studies) across arms using a fixed bimonthly regimen [17, 19].…”

“…The mean BCVA at 12 months was 0.39 ± 0.41 logMAR (∼20/50 Snellen, n = 43 eyes; 3 studies) across study arms administering anti-VEGF agents using a PRN regimen [10, 19, 21], 0.41 ± 0.30 logMAR (∼20/50 Snellen, n = 144 eyes, 3 studies) across arms using a T&E regimen [10, 17, 18], and 0.17 ± 0.28 logMAR (∼20/32 Snellen, n = 61 eyes, 3 studies) across arms using a fixed bimonthly regimen [17, 19, 21]. The mean improvement in BCVA from baseline was 0.08 ± 0.25 logMAR (mean follow-up = 12 months, n = 33 eyes, 2 studies) across study arms administering anti-VEGF agents using a PRN regimen [10, 19], 0.15 ± 0.26 logMAR (mean follow-up = 11.5 months, n = 270 eyes, 4 studies) across arms using a T&E regimen [10, 17, 18, 20], and 0.15 ± 0.21 logMAR (mean follow-up = 12 months, n = 38 eyes, 2 studies) across arms using a fixed bimonthly regimen [17, 19]. The mean RT at 12 months was 253.93 ± 110.71 μm ( n = 27 eyes, 2 studies) across study arms administering anti-VEGF agents using a PRN regimen [19, 21], 244.05 ± 83.48 μm ( n = 130 eyes, 2 studies) across arms using a T&E regimen [17, 18], and 238.60 ± 74.89 μm ( n = 61 eyes, 3 studies) across study arms using a fixed bimonthly regimen [17, 19, 21].…”

“…The article by Rouvas et al [10] from Greece prospectively recruited 30 eyes treated with 2.0 mg aflibercept using a T&E regimen ( n = 14) or a PRN treatment regimen ( n = 16). All patients received 3 initial monthly injections of aflibercept and one PDT session.…”

“…Most included studies reported on aflibercept, one reported on ranibizumab, and one on conbercept. Two studies allowed for patients to receive PDT across both treatment arms [10, 20]. Our included studies varied in the length of last study observation, and there was a paucity of data on adverse events.…”

The comparison of two different strategies of intravitreal conbercept for polypoidal choroidal vasculopathy in Chinese patients results from a 48‐week randomized phase 4 study: STAR study

“…A number of studies have demonstrated that TAE regimens of aflibercept monotherapy are also suitable for PCV patients. Prior studies have reported that PCV patients can achieve BCVA gains of 3.7 to 8.1 letters with 47%–67% of patients extended to treatment intervals of ≥12 weeks (Chaikitmongkol et al, 2021; Hosokawa et al, 2017; Morimoto et al, 2017; Rouvas et al, 2021; Silva et al, 2022; Tamachi et al, 2020). Based on this pool of evidence that TAE regimens can reduce treatment burden and still yield beneficial visual outcomes for patients with PCV comparing with 3 + PRN regimen, the APVRS expert panel recommends the use of TAE regimens for the management of patients with PCV in the Asia‐Pacific region (Chaikitmongkol et al, 2021).…”