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

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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

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
  • 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:

  • Nasolacrimal duct obstruction
  • Major ocular anomalies (e.g., cataract, coloboma)
  • 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

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

Trial documents
3

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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