Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Vision Research Foundation
Study ID
NCT01232777
Phase
PHASE2
Status
Withdrawn

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
30 Weeks - 36 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.

Study Details

The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age.

Key Dates

First listed
Nov 2, 2010
Start date
Jun 30, 2012
Status verified
Oct 2013
Primary completion
Apr 30, 2015
Completion
Jul 31, 2018

Study Design

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

Arms

  • Active Comparator: Bevacizumab (Avastin) 0.75mg/0.03cc
    1/3 of study participants will be randomized to this treatment in one eye (study eye) and the other eye will receive laser (fellow eye)
  • Active Comparator: Bevacizumab (Avastin) 0.625mg/0.025cc
    1/3 of patients will be randomized to this treatment in 1 eye (study eye) and the other eye will receive laser (fellow eye).
  • Active Comparator: Laser ablation
    1/3 of study participants will be randomized to this treatment in both eyes (study eye and fellow eye)

Primary Outcome Measure

To demonstrate non-inferiority of Anti-VEGF treatment to standard-of-care laser [ Time Frame: With patient #58, 116 and 174 (within 3 months after each patient being enrolled) ]

Locations (18)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Jules Stein Eye Institute, UCLALos AngelesCalifornia90095-
Eye Insitute at StanfordPalo AltoCalifornia94303-
Bascon Palmer Eye InstituteMiamiFlorida33136-
Emory Eye CenterAtlantaGeorgia30322-
Children's Hospital, Dept. of OphthalmologyBostonMassachusetts02115-
Associated Retinal Consultants/William Beaumont HospitalRoyal OakMichigan48073-
Insitute of Ophthalmology and Medical Science, New Jersey Medical SchoolNewarkNew Jersey07103-
Department of Ophthalmology, Weill Cornell Medical CollegeNew YorkNew York10021-
Abrahamson Pediatric Eye Institute, Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Cleveland ClinicClevelandOhio44105-
Midwest RetinaDublinOhio43016-
University Hospitals Eye Insitute, Rainbow Babies & Children's HospitalMayfield HeightsOhio44134-
St. Christopher's Hospital for Children, Drexel Univ. School of MedicinePhiladelphiaPennsylvania19134-
Austin Retina AssociatesAustinTexas78705-
Texas Children's HospitalHoustonTexas77030-
University of Utah, Moran Eye CenterSalt Lake CityUtah84132-
Medical College of Wisconsin--Eye InsitituteMilwaukeeWisconsin53266-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAJules Stein Eye Institute, UCLA· Los Angeles, CAEye Insitute at Stanford· Palo Alto, CABascon Palmer Eye Institute· Miami, FLEmory Eye Center· Atlanta, GAChildren's Hospital, Dept. of Ophthalmology· Boston, MA

Related Studies