Trials / Completed
CompletedNCT04527107
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Oxurion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | THR-149 dose level 1 | 3 intravitreal injections of THR-149 dose level 1, 1 month apart |
| DRUG | THR-149 dose level 2 | 3 intravitreal injections of THR-149 dose level 2, 1 month apart |
| DRUG | THR-149 dose level 3 | 3 intravitreal injections of THR-149 dose level 3, 1 month apart |
| DRUG | THR-149 0.13mg | 3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection |
| DRUG | THR-149 0.13mg + aflibercept 2mg | 3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg |
| DRUG | aflibercept 2mg + THR-149 0.13mg | 3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level) |
| DRUG | Aflibercept 2mg | 3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection |
Timeline
- Start date
- 2020-07-31
- Primary completion
- 2023-09-28
- Completion
- 2023-11-22
- First posted
- 2020-08-26
- Last updated
- 2023-11-27
Locations
78 sites across 8 countries: United States, Czechia, France, Germany, Italy, Slovakia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04527107. Inclusion in this directory is not an endorsement.