Two regimens of intravitreal Conbercept improve outcomes in polypoidal choroidal vasculopathy: STAR study.
A new study found that both the fixed dosing regimen and the treat-and-extend regimen of intravitreal conbercept (IVC) resulted in improvement in visual and anatomical outcomes in polypoidal choroidal vasculopathy (PCV) patients. The study results were published in the journal Acta Ophthalmologica.
Polypoidal choroidal vasculopathy (PCV) is a subtype of neovascular age-related macular degeneration (nAMD). Out of the multiple therapeutic options, available Conbercept is a novel fusion protein used for the management of nAMD. Previous literature has shown the efficacy of conbercept in nAMD but there is meager information on the optimal treatment strategy for use in clinical practice. Hence researchers conducted a multicenter, parallel, open-label, randomized clinical trial in 32 eye centers in China to compare the efficacy and safety of two different treatment regimens of IVC for PCV.
249 patients who are treatment naïve with PCV were randomized 1:1 to two groups. They are the fixed dosing regimen group with injections given every 12 weeks (3 + Q12W) and the treat-and-extend regimen (3 + TAE) group. A loading dose of 3 monthly 0.5 mg intravitreal injections of conbercept was given to patients as a 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 the 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 the following
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) |
complete polypoidal lesion regression rate | (p = 0.814) |
- The 3 + Q12W group had more decreased retinal hemorrhage area (p = 0.014) and fewer mean numbers of injections compared with the 3 + TAE group (6.6 vs. 9.4, p < 0.001).
- The mean maximum extension interval between injections after loading injections was 9.6 ± 2.0 weeks for the 3 + TAE group. An extension interval of 12 weeks was achieved by 27.8% of patients and 61.1% of patients achieved 8 weeks or more.
Thus, in PCV patients both the fixed dosing regimen and treat-and-extend regimens of IVC resulted in improvements in visual and anatomical outcomes.
Further reading: Li X, Qu J, Su G, et al. 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 [published online ahead of print, 2022 Oct 18]. Acta Ophthalmol. 2022;10.1111/aos.15272. doi:10.1111/aos.15272
