Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634578
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2020-11-16
Brief Title:
Bevacizumab Treatment For Type 1 ROP
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
Bevacizumab Treatment For Type 1 Retinopathy of Prematurity
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROP4
Brief 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 0063 mg and 025mg are effective as treatment for type 1 ROP with ROP and retinal vessels all in zone I
Detailed Description:
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned 11 to treatment with either intravitreous bevacizumab 0063 mg or either intravitreous bevacizumab 025 mg Study exams will be at 1 day 4 days if no improvement on day 1 1 2 3 and 4 weeks and at 2 and 4-months post-treatment and re-treatment when indicated Additional study exams will occur at adjusted age 6 and 12 months Non-study examinations will be at clinician discretion and are likely to occur more often The primary outcome will be treatment success within each dose group defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection Important secondary outcomes include safety and efficacy refractive outcomes and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1EY011751 | NIH | None | httpsreporternihgovquickSearchUG1EY011751 |