Trials / Completed
CompletedNCT04015180
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090
An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 13 Months
- Healthy volunteers
- Not accepted
Summary
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eylea (Aflibercept, BAY86-5321) | Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection. |
| PROCEDURE | Laser photocoagulation | Treatment administered in 20090. Transpupillary conventional laser ablative therapy |
Timeline
- Start date
- 2020-03-18
- Primary completion
- 2025-09-19
- Completion
- 2025-09-19
- First posted
- 2019-07-10
- Last updated
- 2025-10-10
Locations
55 sites across 24 countries: Argentina, Belgium, Brazil, Bulgaria, Czechia, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Portugal, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT04015180. Inclusion in this directory is not an endorsement.