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

Abstract

To compare a treat-and-extend (TAE) strategy with a fixed dosing regimen of intravitreal conbercept (IVC) for the management of treatment-naïve polypoidal choroidal vasculopathy (PCV) patients.Methods: 249 patients with treatment-naïve PCV were randomized 1:1 to fixed dosing regimen with injections every 12 weeks (3 + Q12W) group or treat-and-extend regimen(3 + TAE) group. Patients received 3 monthly intravitreal injections of 0.5 mg conbercept as loading dose in both groups. The 3 + Q12W patients were monitored monthly and received mandated injections every 12 weeks; the 3 + TAE patients were monitored and treated monthly until the resolution of exudative disease activity; the interval between visits was then individualized according to study protocol. Visual and anatomical outcomes were compared between the two groups.Results: At 48 weeks, there was no significant difference between the 3 + Q12W group and 3 + TAE group in mean BCVA improvement (p = 0.421), mean changes in central retinal thickness (CRT) (p = 0.818), maximum retinal thickness (MRT) (p = 0.448), pigment epithelial detachment (PED) height (p = 0.221), PED volume (p = 0.076), branching vascular network (BVN) area (p = 0.615), polypoidal lesion number (p = 0.701), polypoidal lesion area (p = 0.424), rates of patients who avoided vision loss of ≥15 ETDRS letters (p = 0.397) or complete polypoidal lesion regression rate (43.8% vs. 41.8%, p = 0.814). The 3 + Q12W group had more decreased retinal haemorrhage area (p = 0.014) and fewer mean numbers of injections comparing with 3 + TAE group (6.6 vs. 9.4, p < 0.001). Mean maximum extension interval between injections after loading injections was 9.6 ± 2.0 weeks for 3 + TAE group, with 27.8% of patients achieving an extension interval of 12 weeks and 61.1% patients 8 weeks or more.Conclusions: Both 3 + Q12W and 3 + TAE regimens of IVC could result in improvement in visual and anatomical outcomes in PCV patients.

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

“…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 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 mean improvement in RT from baseline was 137.35 ± 158.81 μm (mean follow-up = 11.5 months, n = 256 eyes, 3 studies) across study arms administering anti-VEGF agents using a T&E regimen [17, 18, 20]. Overall, the complete polyp closure rate was 44.6% ( n = 112/251 eyes, 3 studies) across study arms administering anti-VEGF agents using a T&E regimen [17, 18, 20] and 45.9% ( n = 17/37 eyes, 2 studies) across arms using a fixed bimonthly dosing regimen [17, 19].…”

“…The mean improvement in RT from baseline was 137.35 ± 158.81 μm (mean follow-up = 11.5 months, n = 256 eyes, 3 studies) across study arms administering anti-VEGF agents using a T&E regimen [17, 18, 20]. Overall, the complete polyp closure rate was 44.6% ( n = 112/251 eyes, 3 studies) across study arms administering anti-VEGF agents using a T&E regimen [17, 18, 20] and 45.9% ( n = 17/37 eyes, 2 studies) across arms using a fixed bimonthly dosing regimen [17, 19].…”

“…The STAR study by Li et al [20] was a phase 4 randomized controlled trial in China of 249 eyes with PCV treated with 0.5 mg conbercept using a fixed-dosing regimen every 12 weeks ( n = 123) or a T&E treatment regimen ( n = 126). All patients received 3 initial monthly injections of conbercept.…”

“…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.…”