Retinopathy of Prematurity Clinical Trial
— ROP4Official title:
Bevacizumab Treatment For Type 1 Retinopathy of Prematurity
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Jaeb Center for Health Research | National Eye Institute (NEI), Pediatric Eye Disease Investigator Group |
United States, Canada,
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 |
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