Clinical trial of Conbercept ophthalmic injection for the treatment of polypoidal choroidal vasculopathy (STAR study)

Author: Xiaoxin Li (China)

Co-authors:

Purpose

This study is to comprehensively evaluate the efficacy of conbercept ophthalmic injection for polypoidal choroidal vasculopathy (PCV) using two different administration methods.

Setting/Venue

This was a parallel-group, randomized, open-label, multi-center, phase IV clinical study, lasting 50 weeks (2-week screening period and 48-week treatment period).

Methods

304 subjects were screened and randomly assigned to the fixed-dosing group of 0.5 mg conbercept (3+Q12W group) or the treat-and-extend group of 0.5 mg conbercept (3+TAE group) in a 1:1 ratio. The primary endpoint was evaluated after 48 weeks of treatment. The main endpoints were the mean changes in best corrected visual acuity (BCVA), central retinal thickness (CRT), polyp lesion area, and polyp regression.

Results

A total of 304 subjects were randomized; 152 subjects in the 3+Q12W group and 152 subjects in the 3+TAE group. Baseline visual acuity was 61.54±13.96 and 60.4±14.58 letters, respectively, and baseline CRT was 422.94±152.69 µm and 411.12±141.35 µm, respectively.After 48 weeks, visual acuity in the 3+Q12W group and 3+T&E group increased by 5.67±16.38 and 6.54±14.58 letters respectively; the proportion of patients with visual acuity improvement of ≥15 letters were 26% and 23%, respectively; CRT decreased by 96.76±157.80 µm and 108.22±167.58 µm; respectively; the rate of complete polyp regression was 38% and 37% respectively; the proportion of polyps under effective control was 82% and 85% respectively; the polyp area decreased by 42% and 44%, respectively; the recovery rate of PDT was 11.38% and 7.14%, respectively. The average number of injections in the two groups was 6.55 and 9.37, respectively. The incidence of adverse events was 28.09%, the incidence of target-eye adverse events was 14.72%, and the incidence of serious adverse events was 0.33%.

Conlusions

The STAR study confirmed that 0.5 mg conbercept 3+Q12W and 3+T&E are effective and safe in the treatment of PCV. Both treatments can significantly improve visual acuity and eliminate polyps. The 3+Q12W group needed fewer injections.

Financial Disclosure

Financial support: Chengdu Kanghong Pharmaceutical Group