Trials / Completed
CompletedNCT03499223
A Study to Evaluate THR-317 and Ranibizumab Combination Treatment for Diabetic Macular Oedema (DME)
A Phase 2, Randomised, Single-masked, Active-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Intravitreal THR-317 Administered in Combination With Ranibizumab, for the Treatment of Diabetic Macular Oedema (DME)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Oxurion · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is conducted to evaluate the safety of intravitreal THR-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST), in subjects with central-involved diabetic macular oedema (CI-DME).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ranibizumab 0.5mg | 3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart |
| DRUG | THR-317 8mg | 3 intravitreal injections of THR-317 8mg, approximately 1 month apart |
| DRUG | Sham injection | 3 sham injections, approximately 1 month apart. No actual injections. No medication is used. |
Timeline
- Start date
- 2018-04-20
- Primary completion
- 2019-07-18
- Completion
- 2019-07-18
- First posted
- 2018-04-17
- Last updated
- 2019-08-02
Locations
37 sites across 7 countries: Belgium, France, Germany, Slovakia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03499223. Inclusion in this directory is not an endorsement.