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

NCT01232777 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-10-17

No results posted yet for this study

Summary

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.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Bevacizumab

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

Sponsors & Collaborators

  • Vision Research Foundation

    lead OTHER

Principal Investigators

  • Michael T Trese, MD · Vision Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-04-30
Completion
2018-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01232777 on ClinicalTrials.gov