Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity



Status:Recruiting
Conditions:Ocular, Ocular, Women's Studies
Therapuetic Areas:Ophthalmology, Reproductive
Healthy:No
Age Range:Any
Updated:4/5/2019
Start Date:April 28, 2015
End Date:September 2022
Contact:Raymond Kraker, MSPH
Email:rkraker@jaeb.org
Phone:813-975-8690

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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.

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.

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.
We found this trial at
11
sites
Columbus, Ohio 43205
Phone: 614-224-6222
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Atlanta, Georgia 30322
Phone: 404-778-4725
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Baltimore, Maryland 21287
Phone: 410-955-8314
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-6401
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Cincinnati, Ohio 45229
Phone: 513-636-4751
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Durham, North Carolina 27710
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Durham, NC
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Houston, Texas 77030
Phone: 832-822-3230
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Phone: 317-274-1214
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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880 Kempsville Road
Norfolk, Virginia 23502
Phone: 757-461-0050
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Norfolk, VA
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Oklahoma City, Oklahoma 73104
Phone: 405-271-1094
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Oklahoma City, OK
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Salt Lake City, Utah 84132
Phone: 801-581-2352
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Salt Lake City, UT
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