Trials / Completed
CompletedNCT04004208
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 32 Weeks
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eylea (Aflibercept, BAY86-5321) | Solution in a sterile glass vial, Dose A, IVT injection. |
| PROCEDURE | Laser photocoagulation | Transpupillary conventional laser ablative therapy |
Timeline
- Start date
- 2019-09-25
- Primary completion
- 2021-02-12
- Completion
- 2021-02-12
- First posted
- 2019-07-01
- Last updated
- 2022-05-06
- Results posted
- 2022-05-06
Locations
90 sites across 27 countries: Argentina, Austria, Belgium, Brazil, Bulgaria, Czechia, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04004208. Inclusion in this directory is not an endorsement.