Trials / Completed
CompletedNCT04101721
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aflibercept | Administered IVT |
| PROCEDURE | laser photocoagulation | Transpupillary conventional laser will be administered according to standard local procedures. |
Timeline
- Start date
- 2019-10-30
- Primary completion
- 2022-08-18
- Completion
- 2022-08-18
- First posted
- 2019-09-24
- Last updated
- 2023-07-20
- Results posted
- 2023-07-20
Locations
52 sites across 13 countries: United States, Bulgaria, Colombia, Czechia, Hungary, Romania, Russia, Slovakia, South Korea, Taiwan, Thailand, Turkey (Türkiye), Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04101721. Inclusion in this directory is not an endorsement.