A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

Anti-PlGF recombinant monoclonal antibody, 4mg dose

Anti-PlGF recombinant monoclonal antibody, 8mg dose

Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject

Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject

Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150

Proportion of subjects withdrawn from repeat injection and reason for withdrawal

Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit

Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection

Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit

Mean change from baseline in BCVA, by study visit

Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)