Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04015180 | Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090 | PHASE3 | COMPLETED | 100 | — | — | Mar 18, 2020 | Sep 19, 2025 | Oct 10, 2025 | 55 | Argentina, Belgium +22 |
| NCT04004208 | Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy | PHASE3 | COMPLETED | 113 | — | — | Sep 25, 2019 | Feb 12, 2021 | May 6, 2022 | 90 | Argentina, Austria +25 |
AE: adverse event SAE: serious adverse event
Active ROP was defined as ROP requiring treatment. Unfavorable structural outcomes included retinal detachment, macular dragging, macular fold, or retrolental opacity.
| Arm | Type | Description |
|---|---|---|
| Aflibercept arm | EXPERIMENTAL | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
| Laser photocoagulation arm | ACTIVE_COMPARATOR | No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090. |
| Name | Type | Description |
|---|---|---|
| Eylea (Aflibercept, BAY86-5321) | DRUG | Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection. |
| Laser photocoagulation | PROCEDURE | Treatment administered in 20090. Transpupillary conventional laser ablative therapy |
Inclusion Criteria: * Subject was treated in Study 20090 * Age less than 13 months of chronological age * Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in th...