Bevacizumab Treatment For Type 1 ROP

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Jaeb Center for Health Research
Study ID
NCT04634578
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Nov 18, 2020
Start date
May 1, 2022
Status verified
Feb 2026
Primary completion
Jul 1, 2025
Completion
Jul 1, 2027

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab- 0.063 mg
    Participants will receive a single intravitreal injection of 0.063 mg 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.
  • Experimental: Bevacizumab- 0.25 mg
    Participants will receive a single intravitreal injection of 0.25 mg 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.

Primary Outcome Measure

Treatment Success at 4 Weeks Post Injection [ Time Frame: 4 weeks ]

Locations (25)

FacilityCityStateZIPSite coordinators
Arkansas Childrens Hospital/ University of Arkansas Medical SciencesLittle RockArkansas72202-
Univ of California, Irvine- Gavin Herbert Eye InstituteIrvineCalifornia92697-
Jules Stein Eye Institute at the University of California, Los AngelesLos AngelesCalifornia90095-
University of California, DavisSacramentoCalifornia95817-
University of California San Francisco Department of OphthalmologySan FranciscoCalifornia94143-
The Emory Eye CenterAtlantaGeorgia30322-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
U of Illinois at Chicago Eye and Ear InfirmaryChicagoIllinois60612-
University of ChicagoHyde ParkIllinois60637-
Indiana University School of MedicineIndianapolisIndiana46202-
Riley Hospital for ChildrenIndianapolisIndiana46202-
UK Ophthalmology and Visual Sciences, The Eye ClinicLexingtonKentucky40508-
Greater Baltimore Medical CenterBaltimoreMaryland21204-5809-
Boston Children's HospitalBostonMassachusetts02215-
New York Presbyterian David H Koch CenterNew YorkNew York10065-
Duke University Eye CenterDurhamNorth Carolina27710-
Cincinnati Children's HospitalCincinnatiOhio45229-
Pediatric Ophthalmology Associates, Inc.ColumbusOhio43205-
Casey Eye InstitutePortlandOregon97239-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
UPMC Children's Eye Center of Children's Hospital of PittsburghPittsburghPennsylvania15224-
Storm Eye InstituteMt. PleasantSouth Carolina29464-
Texas Children's Hospital - Dept. Of OphthalmologyHoustonTexas77030-
University of Utah Moran Eye CenterSalt Lake CityUtah84132-
Virginia Pediatric Eye CenterNorfolkVirginia23502-

Find similar trials in Little Rock, AR

By research site
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences· Little Rock, ARUniv of California, Irvine- Gavin Herbert Eye Institute· Irvine, CAJules Stein Eye Institute at the University of California, Los Angeles· Los Angeles, CAUniversity of California, Davis· Sacramento, CAUniversity of California San Francisco Department of Ophthalmology· San Francisco, CAThe Emory Eye Center· Atlanta, GA

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