Trials / Completed
CompletedNCT03071068
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- ThromboGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anti-PlGF recombinant monoclonal antibody, 4mg dose | 3 intravitreal injections of THR-317 4mg approximately 1 month apart |
| DRUG | Anti-PlGF recombinant monoclonal antibody, 8mg dose | 3 intravitreal injections of THR-317 8mg approximately 1 month apart |
Timeline
- Start date
- 2016-12-22
- Primary completion
- 2018-04-01
- Completion
- 2018-04-01
- First posted
- 2017-03-06
- Last updated
- 2018-04-17
Locations
13 sites across 3 countries: Czechia, Hungary, Slovakia
Source: ClinicalTrials.gov record NCT03071068. Inclusion in this directory is not an endorsement.