Trials / Completed
CompletedNCT02134457
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity
Multicenter Randomized Double Masked Parallel Design Exploratory Study to Assess Safety and Efficacy of Two Different Doses of Intravitreal Anti-VEGF Treatment With Ranibizumab (0.12 mg vs. 0.20 mg) in Infants With Retinopathy of Prematurity (ROP)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- University Hospital Freiburg · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates. The primary objective is to assess clinical efficacy of ranibizumab in children with ROP
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ranibizumab |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2014-05-09
- Last updated
- 2017-03-09
Locations
9 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT02134457. Inclusion in this directory is not an endorsement.