drugset / Trial / NCT04634578
Bevacizumab Treatment For Type 1 ROP
Phase 2
Active not recruiting
77 enrolled
Jaeb Center for Health Research
National Eye Institute (NEI) · collabPediatric Eye Disease Investigator Group · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2025-07-01
- Completion
- 2027-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 0.063 mg | Intravitreal |
| Subject | Bevacizumab | Monoclonal antibody | 0.25 mg | Intravitreal |