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)

简要总结

主要结局

次要结局

• Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject(up to the 30-day follow-up visit after each injection)
• 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(Up to 7-day follow-up visit after each injection)
• Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit(Up to day 150)
• Mean change from baseline in BCVA, by study visit(Up to day 150)
• 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)(Up to day 150)
• Proportion of subjects withdrawn from repeat injection and reason for withdrawal(At day 30 and at day 60)
• Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit(Up to day 150)
• Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150(From day 0 to day 150)