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Bevacizumab Treatment For Posterior Zone I ROP (ROP4)

Primary Purpose

Retinopathy of Prematurity

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinopathy of Prematurity

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

  1. Birth weight < 1251 grams
  2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will be excluded from study participation.

  1. Previous treatment for ROP
  2. Stage 4 or 5 ROP in either eye
  3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
  4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
  5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
  6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

  • Visually significant ocular anomaly (e.g., cataract, coloboma)
  • Opacity that precludes an adequate view of the retina

Sites / Locations

  • Arkansas Childrens Hospital/ University of Arkansas Medical SciencesRecruiting
  • Univ of California, Irvine- Gavin Herbert Eye InstituteRecruiting
  • Jules Stein Eye Institute at the University of California, Los AngelesRecruiting
  • University of California, Davis
  • University of California San Francisco Department of OphthalmologyRecruiting
  • Denver Health and Hospital Authority
  • Connecticut Childrens Medical Center
  • The Emory Eye CenterRecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • U of Illinois at Chicago Eye and Ear InfirmaryRecruiting
  • University of ChicagoRecruiting
  • Indiana University School of MedicineRecruiting
  • Riley Hospital for Children
  • UK Ophthalmology and Visual Sciences, The Eye ClinicRecruiting
  • Greater Baltimore Medical CenterRecruiting
  • Boston Children's HospitalRecruiting
  • University of Missouri- Columbia Mason Eye Institute
  • St. Louis University Ophthalmology
  • New York Presbyterian David H Koch CenterRecruiting
  • University of North Carolina
  • Duke University Eye CenterRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Pediatric Ophthalmology Associates, Inc.Recruiting
  • Casey Eye InstituteRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • UPMC Children's Eye Center of Children's Hospital of Pittsburgh
  • Storm Eye InstituteRecruiting
  • Texas Children's Hospital - Dept. Of OphthalmologyRecruiting
  • The Woman's Hospital of Texas
  • Texas Retina Associates
  • University of Utah Moran Eye CenterRecruiting
  • Virginia Pediatric Eye CenterRecruiting
  • Surrey Memorial Hospital
  • IWK Health Centre
  • The Hospital for Sick Children
  • CHU - Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bevacizumab- 0.063 mg

Bevacizumab- 0.25 mg

Arm Description

Participants will receive a single intravitreal injection of 0.063 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Participants will receive a single intravitreal injection of 0.25 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Outcomes

Primary Outcome Measures

Treatment Success at 4 Weeks Post Injection
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: Improvement by the 4-day exam (3 to 5 days) No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
October 18, 2022
Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT04634578
Brief Title
Bevacizumab Treatment For Posterior Zone I ROP
Acronym
ROP4
Official Title
Bevacizumab Treatment For Posterior Zone I Retinopathy of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.
Detailed Description
Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab- 0.063 mg
Arm Type
Experimental
Arm Description
Participants will receive a single intravitreal injection of 0.063 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Arm Title
Bevacizumab- 0.25 mg
Arm Type
Experimental
Arm Description
Participants will receive a single intravitreal injection of 0.25 mg of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria. Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.
Primary Outcome Measure Information:
Title
Treatment Success at 4 Weeks Post Injection
Description
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: Improvement by the 4-day exam (3 to 5 days) No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
Time Frame
4 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate: Birth weight < 1251 grams Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes Exclusion Criteria: Participants meeting any of the following exclusion criteria will be excluded from study participation. Previous treatment for ROP Stage 4 or 5 ROP in either eye Treatment could not be done within 2 days of diagnosis of type 1 ROP Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits. Active ocular infection or purulent nasolacrimal duct obstruction in either eye One eye will be excluded, and other eye may be eligible, if either of the following are present: Visually significant ocular anomaly (e.g., cataract, coloboma) Opacity that precludes an adequate view of the retina
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond T Kraker, MSPH
Phone
8139758690
Email
rkraker@jaeb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke P Fimbel
Phone
8139758690
Email
bfimbel@jaeb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David K Wallace, MD, MPH
Organizational Affiliation
Indiana University
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florin Grigorian, MD
Phone
501-364-4125
Email
fgrigorian@uams.edu
Facility Name
Univ of California, Irvine- Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donny Suh, MD, MBA
Phone
949-824-9089
Email
dowsuh@gmail.com
Facility Name
Jules Stein Eye Institute at the University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy L Pineles, MD
Phone
310-825-2872
Email
pineles@jsei.ucla.edu
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcela M Estrada, MD
Phone
916-734-8755
Email
mmestrada@ucdavis.edu
Facility Name
University of California San Francisco Department of Ophthalmology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra de Alba Campomanes, MD
Phone
415-353-2560
Email
dealbaa@vision.ucsf.edu
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse M Smith, MD
Phone
303-436-6000
Email
jesse.smith@dhha.org
Facility Name
Connecticut Childrens Medical Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janine E Collinge, MD
Phone
860-837-9600
Email
jcollinge@connecticutchildrens.org
Facility Name
The Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Hutchinson, MD
Phone
404-778-4725
Email
amy.hutchinson@emory.edu
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudhi Kurup, MD
Phone
312-227-6189
Email
SKurup@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Hawke H Yoon, MD
First Name & Middle Initial & Last Name & Degree
Safa Rahmani, MD
Facility Name
U of Illinois at Chicago Eye and Ear Infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel E Maidana, MD, PhD
Email
maidana@uic.edu
Facility Name
University of Chicago
City
Hyde Park
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah H Rodriguez
Phone
773-702-3937
Email
srodriguez5@bad.uchicago.edu
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David K Wallace, MD, MPH
Phone
317-278-2651
Email
dwallac@iu.edu
First Name & Middle Initial & Last Name & Degree
David K Wallace, MD, MPH
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Haider, MD
Phone
317-274-1214
Email
khaider@iupui.edu
Facility Name
UK Ophthalmology and Visual Sciences, The Eye Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John M Franklin, MD
Phone
859-323-5868
Email
john.franklin@uky.edu
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204-5809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison A Jensen, MD
Phone
443-849-6341
Email
ajensen@gbmc.org
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Wu, MD
Email
carolyn.wu@childrens.harvard.edu
Facility Name
University of Missouri- Columbia Mason Eye Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Elkeeb, MD
Phone
573-875-9000
Email
elkeeba@health.missouri.edu
Facility Name
St. Louis University Ophthalmology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley V Davitt, MD
Phone
314-977-4931
Email
davittb@slu.edu
Facility Name
New York Presbyterian David H Koch Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Orlin, MD
Phone
646-697-6428
Email
ano9028@med.cornell.edu
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Go, MD
Phone
919-966-5296
Email
michelle_go@med.unc.edu
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon F Freedman, MD
Phone
919-684-2038
Email
Freed003@mc.duke.edu
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yang, MD
Phone
513-636-4751
Email
Michael.Yang@cchmc.org
Facility Name
Pediatric Ophthalmology Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Rogers, MD
Phone
614-224-6222
Email
david.rogers@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Amanda L Way, MD
First Name & Middle Initial & Last Name & Degree
Catherine O Jordan, MD
First Name & Middle Initial & Last Name & Degree
Hilliary E Inger, MD
First Name & Middle Initial & Last Name & Degree
Mary Lou McGregor, MD
First Name & Middle Initial & Last Name & Degree
Richard P Golden, MD
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Campbell
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne K Jensen, MD
Email
anne.kelso.jensen@gmail.com
Facility Name
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Nischal, MD
Phone
412-692-5918
Email
nischalkk@upmc.edu
Facility Name
Storm Eye Institute
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Bowsher
Facility Name
Texas Children's Hospital - Dept. Of Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Bhatt, MD
Phone
832-822-3230
Email
arbhatt@texaschildrens.org
Facility Name
The Woman's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charity H Grannis, MD
Phone
713-790-1234
Email
cgrannis@houstoneye.com
Facility Name
Texas Retina Associates
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Shami, MD
Phone
806-792-0066
Email
ysaldivar@texasretina.com
Facility Name
University of Utah Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Elizabeth Hartnett, MD
Phone
801-581-2352
Email
ME.Hartnett@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Griffin Jardine, MD
Facility Name
Virginia Pediatric Eye Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Crouch, MD
Phone
757-461-0050
Email
ercrouch@gmail.com
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Gizicki, MD
Phone
604-581-2211
Email
r.gizicki@gmail.com
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johane M Robitaille, MD
Phone
902-470-8731
Email
jrobitai@dal.ca
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masrin Najm-Tehran, MD
Phone
416-813-7654
Ext
201401
Email
nasrin.tehrani@sickkids.ca
Facility Name
CHU - Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanne Superstein, MD
Phone
514-345-4715
Email
rosanne.superstein@mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
IPD Sharing Time Frame
Data will be made available after publication of each primary manuscript.
IPD Sharing Access Criteria
Users accessing the data must enter an email address.
Links:
URL
http://www.pedig.net
Description
PEDIG Public Website

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Bevacizumab Treatment For Posterior Zone I ROP

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