Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity (ROP1)

Jaeb Center for Health Research

Status and phase: Completed; Phase 1

Conditions: Retinopathy of Prematurity

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT02390531

ROP1

2U10EY011751 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe ROP, little is known about lower doses of bevacizumab for ROP. An increasing number of ophthalmologists are treating premature infants with severe ROP using bevacizumab. Given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. The proposed study will test progressively lower doses to find a dose to take forward to a future larger study.

Enrollment: 120 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 1 ROP; defined as:

   • Zone I, any stage ROP with plus disease, or
   • Zone I, stage 3 ROP without plus disease, or
   • Zone II, stage 2 or 3 ROP with plus disease

2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

Exclusion criteria

The following exclusions apply to the study eye:

1. Nasolacrimal duct obstruction
2. Major ocular anomalies (e.g., cataract, coloboma)
3. Any opacity that precludes an adequate view of the retina

If purulent ocular discharge is present in either eye, then the infant is ineligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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120 participants in 8 patient groups

Bevacizumab 0.250 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.125 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.063 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.031 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.016 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.008 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.004 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab

Bevacizumab 0.002 mg

Experimental group

Description:

Dosage of injected Bevacizumab to be studied

Treatment:

Drug: Bevacizumab