Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Jaeb Center for Health Research
Study ID
NCT02390531
Phase
PHASE1
Status
Completed

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.

Key Dates

First listed
Mar 17, 2015
Start date
Apr 28, 2015
Status verified
Nov 2022
Primary completion
Jun 4, 2019
Completion
May 11, 2021

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab 0.250 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.125 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.063 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.031 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.016 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.008 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.004 mg
    Dosage of injected Bevacizumab to be studied
  • Experimental: Bevacizumab 0.002 mg
    Dosage of injected Bevacizumab to be studied

Primary Outcome Measure

Number of Participants With Successful Treatment of ROP [ Time Frame: 4 weeks post-injection ]

Locations (11)

FacilityCityStateZIPSite coordinators
The Emory Eye CenterAtlantaGeorgia30322-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Wilmer InstituteBaltimoreMaryland21287-
Boston Children's HospitalBostonMassachusetts02115-
Duke University Eye CenterDurhamNorth Carolina27710-
Cincinnati Children's HospitalCincinnatiOhio45229-
Pediatric Ophthalmology Associates, Inc.ColumbusOhio43205-
Dean A. McGee Eye Institute, University of OklahomaOklahoma CityOklahoma73104-
Texas Children's Hospital - Dept. Of OphthalmologyHoustonTexas77030-
University of Utah Moran Eye CenterSalt Lake CityUtah84132-
Virginia Pediatric Eye CenterNorfolkVirginia23502-

Find similar trials in Atlanta, GA

By research site
The Emory Eye Center· Atlanta, GARiley Hospital for Children· Indianapolis, INWilmer Institute· Baltimore, MDBoston Children's Hospital· Boston, MADuke University Eye Center· Durham, NCCincinnati Children's Hospital· Cincinnati, OH

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