Bevacizumab Treatment For Type 1 ROP

Retinopathy of Prematurity Clinical Trial

— ROP4  

Official title:

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634578
• Other study ID #: ROP4
• Secondary ID: UG1EY011751
• Status: Recruiting
• Phase: Phase 2
• Start date: May 18, 2022
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Jaeb Center for Health Research
• Contact: Raymond T Kraker, MSPH
• Phone: 8139758690
• Email: rkraker[@]jaeb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

1. Birth weight < 1251 grams

2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will be excluded from study participation.

1. Previous treatment for ROP

2. Stage 4 or 5 ROP in either eye

3. Treatment could not be done within 2 days of diagnosis of type 1 ROP

4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment

5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.

6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

• Visually significant ocular anomaly (e.g., cataract, coloboma)

• Opacity that precludes an adequate view of the retina

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Drug:
• Bevacizumab
All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria. Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	CHU - Sainte-Justine	Montreal	Quebec
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	The Emory Eye Center	Atlanta	Georgia
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	U of Illinois at Chicago Eye and Ear Infirmary	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University of Missouri- Columbia Mason Eye Institute	Columbia	Missouri
United States	Pediatric Ophthalmology Associates, Inc.	Columbus	Ohio
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Duke University Eye Center	Durham	North Carolina
United States	Connecticut Childrens Medical Center	Farmington	Connecticut
United States	Texas Children's Hospital - Dept. Of Ophthalmology	Houston	Texas
United States	The Woman's Hospital of Texas	Houston	Texas
United States	University of Chicago	Hyde Park	Illinois
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Univ of California, Irvine- Gavin Herbert Eye Institute	Irvine	California
United States	UK Ophthalmology and Visual Sciences, The Eye Clinic	Lexington	Kentucky
United States	Arkansas Childrens Hospital/ University of Arkansas Medical Sciences	Little Rock	Arkansas
United States	Jules Stein Eye Institute at the University of California, Los Angeles	Los Angeles	California
United States	Texas Retina Associates	Lubbock	Texas
United States	Storm Eye Institute	Mount Pleasant	South Carolina
United States	New York Presbyterian David H Koch Center	New York	New York
United States	Virginia Pediatric Eye Center	Norfolk	Virginia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Children's Eye Center of Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Casey Eye Institute	Portland	Oregon
United States	University of California, Davis	Sacramento	California
United States	St. Louis University Ophthalmology	Saint Louis	Missouri
United States	University of Utah Moran Eye Center	Salt Lake City	Utah
United States	University of California San Francisco Department of Ophthalmology	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), Pediatric Eye Disease Investigator Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success at 4 Weeks Post Injection	Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: Improvement by the 4-day exam (3 to 5 days); No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.	4 weeks

External Links

•   PEDIG Public Website