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A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

NCT04634604 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-01

Study results available
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Summary

This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP).

The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Bevacizumab

For infants randomized to bevacizumab, the Intravitreous bevacizumab 0.063 mg injection will be given no later than 2 days after the diagnosis of type 1 ROP. The ophthalmologist may choose to give the intravitreous injection in the operating room or at the bedside, with or without anesthesia, after consultation with the attending neonatologist. A binocular indirect ophthalmoscope with an appropriate condensing lens should be available, and the pupils should be dilated.

PROCEDURE

Laser

For infants randomized to laser treatment, it will be given in conjunction with a binocular indirect ophthalmoscope and an appropriate condensing lens, by a study-certified ophthalmologist experienced in the use of this equipment. The treating investigator will be certified as having sufficient experience with laser for ROP, and adequacy of laser treatment will be confirmed by expert review of photographs. Special laser precautions, as mandated by OSHA and facility standards, will be followed.

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • David K Wallace, MD, MPH · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2023-08-14
Completion
2023-08-14
FDA Drug
Yes

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 NCT04634604 on ClinicalTrials.gov