Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

Part of paid clinical trials in Pasadena, California.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT00622726
Phase
PHASE2
Status
Unknown

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
4 Weeks - 22 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
  • Conventional Laser for ROP — PROCEDURE
    Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)

Study Details

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

Key Dates

First listed
Feb 25, 2008
Start date
Mar 31, 2008
Status verified
May 2017
Primary completion
Aug 31, 2010
Completion
Aug 31, 2020

Study Design

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

Arms

  • Experimental: Bevacizumab for ROP
    Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
  • Active Comparator: Conventional Laser for ROP
    Conventional Laser to the Peripheral Retina is the Control Arm of this Study

Primary Outcome Measure

Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment [ Time Frame: 54 weeks postmenstrual age (window of 50 to 70 weeks) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Huntington Memorial HospitalPasadenaCalifornia91109-
Presbyterian-St. Luke's HospitalDenverColorado80218-
OSF St. Francis Medical Center-Children's Hospital of IllinoisPeoriaIllinois61637-
Palmetto Health Baptist HospitalColumbiaSouth Carolina29223-
Palmetto Health Richland HospitalColumbiaSouth Carolina29203-
Driscoll Children's HospitalCorpus ChristiTexas78411-
Baylor University Medical CenterDallasTexas75346-
Del Sol Medical CenterEl PasoTexas79925-
Las Palmas Medical CenterEl PasoTexas79902-
R.E. Thomason HospitalEl PasoTexas79905-
Cook Children's Medical CenterFort WorthTexas76104-
Children's Memorial Hermann HospitalHoustonTexas77030-
Memorial Hermann Southwest HospitalHoustonTexas77074-
St. Joseph Medical CenterHoustonTexas77002-
Clear Lake Regional Medical CenterWebsterTexas77598-

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