ArticleBMJ open ophthalmology2026
Phase 1 dose-escalation study of IBI324, a VEGF-A/Ang-2 bispecific antibody, for the treatment of diabetic macular oedema.
Article in BMJ open ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05489718 (A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema), which is not on this map. Not yet cited in PubMed.
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A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema(DME)
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Abstract
objectiveTo evaluate the safety, tolerability and preliminary efficacy of IBI324, a vascular endothelial growth factor-A/angiopoietin-2 bispecific antibody, in participants with diabetic macular oedema (DME). METHODS AND ANALYSIS: This multicentre, open-label, phase 1 dose-escalation clinical trial consisted of a single ascending dose (SAD) stage and a multiple ascending dose (MAD) stage. 24 participants with fovea-involving DME were enrolled. SAD participants received a single intravitreal injection (IVT) of 0.5 mg, 2 mg or 4 mg IBI324 and were followed up until Day 42 post injection. In the MAD stage, six participants each received 3 monthly IVTs of 2 mg or 4 mg IBI324 and were followed up until determined as 'treatment needed' per prespecified criteria or until 24 weeks after first dose. The primary endpoints were incidence of dose-limiting toxicities (DLTs), adverse events (AEs) and changes in vital signs and laboratory test findings.
resultsNo DLT, treatment-related AE, AE of special interest or ocular serious AE was reported. Treatment-emergent adverse events (TEAEs), all mild or moderate in severity, were observed in 4 (33.3%) SAD participants and 11 (91.7%) MAD participants. TEAEs of the study eye included intraocular pressure increased, conjunctival haemorrhage, allergic conjunctivitis, posterior capsular opacification and visual acuity decreased. Mean best-corrected visual acuity increase and mean central subfield thickness decrease from baseline in the study eye were observed in all dose groups, accompanied by intraretinal fluid/subretinal fluid improvements. 16 weeks after the last dose, 7 (58.3%) MAD 2 mg and 6 (50.0%) MAD 4 mg participants remained free of 'treatment needed'.
conclusionIBI324 was well tolerated with evidence of functional and anatomical improvement in patients with DME. TRIAL REGISTRATION NUMBER: NCT05489718.
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