drugset / Trial / NCT04527107

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

NCT04527107

Phase 2 Completed 135 enrolled Oxurion
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Timeline

Start
2020-07-31
Primary completion
2023-09-28
Completion
2023-11-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Other
Subject THR-149 Unknown 0.13 mg Other