Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Official Title
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Acronym
ROP1
Organization
Jaeb Center for Health ResearchOTHER
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 28, 2015Actual
Primary Completion Date
Jun 4, 2019Actual
Completion Date
May 11, 2021Actual
First Submitted Date
Feb 17, 2015
First Submission Date that Met QC Criteria
Mar 10, 2015
First Posted Date
Mar 17, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 28, 2022
Results First Submitted that Met QC Criteria
Nov 1, 2022
Results First Posted Date
Nov 3, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 1, 2022
Last Update Posted Date
Nov 3, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Jaeb Center for Health ResearchOTHER
Collaborators
Name
Class
Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed 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.
Conditions Module
Conditions
Retinopathy of Prematurity
Keywords
Retinopathy of Prematurity
Bevacizumab
ROP
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bevacizumab 0.250 mg
Experimental
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Bevacizumab 0.125 mg
Experimental
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Bevacizumab 0.063 mg
Experimental
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Bevacizumab 0.031 mg
Experimental
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Bevacizumab 0.016 mg
Experimental
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Bevacizumab 0.008 mg
Experimental
Dosage of injected Bevacizumab to be studied
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bevacizumab
Drug
Varying dosages in 10µl
Bevacizumab 0.002 mg
Bevacizumab 0.004 mg
Bevacizumab 0.008 mg
Bevacizumab 0.016 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Successful Treatment of ROP
Success is defined as improvement* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
* For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity.
A dose will be considered effective if it successfully treats at least 80% of subjects.
4 weeks post-injection
Secondary Outcomes
Measure
Description
Time Frame
Distribution of VEGF Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of vascular endothelial growth factor (VEGF) and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Wallace DK, Kraker RT, Freedman SF, Crouch ER, Hutchinson AK, Bhatt AR, Rogers DL, Yang MB, Haider KM, VanderVeen DK, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Hartnett ME, Kong L, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Assessment of Lower Doses of Intravitreous Bevacizumab for Retinopathy of Prematurity: A Phase 1 Dosing Study. JAMA Ophthalmol. 2017 Jun 1;135(6):654-656. doi: 10.1001/jamaophthalmol.2017.1055.
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Types
Not provided
Time Frame
Data will be made available after publication of each primary manuscript.
Access Criteria
Users accessing the data must enter an email address.
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Original reported enrollment was 121, however upon further review 2 patient identifiers were found to be the same patient, incorrectly enrolled twice, bringing the correct count to 120.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Bevacizumab (0.250 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 17, 2018
Apr 26, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
8 bevacizumab doses were evaluated in this dose de-escalation study in the following dosage amounts: 0.250mg, 0.125mg, 0.063mg, 0.031mg, 0.016mg, 0.008mg, 0.004mg, 0.002mg. Each dose was planned to be used in up to 14 infants to ensure at least 10 infants with 4-week outcomes
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
4 weeks post-injection
Distribution of Avastin Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
2 weeks post-injection
Distribution of Avastin Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
4 weeks post-injection
Number of Study Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
12-month corrected age
Any Adverse Events or Complications Since the 4-week Exam
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
12-month corrected age
Visual Fixation Status at 12 Months
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
12-month corrected age
Proportion of Infants for Whom at Least One Event Was Reported
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Enrollment to 12-month corrected age
Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Enrollment to 12-month corrected age
Count of Infants for Whom at Least One Serious Adverse Event Was Reported
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method.
Enrollment to 12-month corrected age
Number of Infant Deaths
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Enrollment to 12-month corrected age
Number of Infants With 24-Month Extended Follow Up Exam
A subset of infants enrolled in ROP1 will have extended follow up consisting of one additional office exam with developmental testing.
This testing will provide a cross-sectional evaluation of visual acuity, refractive error, and development at the adjusted age 24-month visit.
24-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 24 months.
24-month corrected age
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
12-month corrected age
Indianapolis
Indiana
46202
United States
Wilmer Institute
Baltimore
Maryland
21287
United States
Boston Children's Hospital
Boston
Massachusetts
02115
United States
Duke University Eye Center
Durham
North Carolina
27710
United States
Cincinnati Children's Hospital
Cincinnati
Ohio
45229
United States
Pediatric Ophthalmology Associates, Inc.
Columbus
Ohio
43205
United States
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City
Oklahoma
73104
United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston
Texas
77030
United States
University of Utah Moran Eye Center
Salt Lake City
Utah
84132
United States
Virginia Pediatric Eye Center
Norfolk
Virginia
23502
United States
Background
Kraker RT, Wallace DK, Beck RW, Saunders CT, Lorenzi E, Melia BM, Li Z; Pediatric Eye Disease Investigator Group. Choice of Dose Level for a Randomized Clinical Trial of Low-Dose Bevacizumab vs Laser for Type 1 Retinopathy of Prematurity. JAMA Ophthalmol. 2021 Oct 1;139(10):1143-1144. doi: 10.1001/jamaophthalmol.2021.3192.
Wallace DK, Dean TW, Hartnett ME, Kong L, Smith LE, Hubbard GB, McGregor ML, Jordan CO, Mantagos IS, Bell EF, Kraker RT; Pediatric Eye Disease Investigator Group. A Dosing Study of Bevacizumab for Retinopathy of Prematurity: Late Recurrences and Additional Treatments. Ophthalmology. 2018 Dec;125(12):1961-1966. doi: 10.1016/j.ophtha.2018.05.001. Epub 2018 Jun 7.
Crouch ER, Kraker RT, Wallace DK, Holmes JM, Repka MX, Collinge JE, Bremer DL, Gray ME, Smith HA, Steinkuller PG; Writing Committee for Pediatric Eye Disease Investigator Group. Secondary 12-Month Ocular Outcomes of a Phase 1 Dosing Study of Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jan 1;138(1):14-20. doi: 10.1001/jamaophthalmol.2019.4488.
Wallace DK, Kraker RT, Freedman SF, Crouch ER, Bhatt AR, Hartnett ME, Yang MB, Rogers DL, Hutchinson AK, VanderVeen DK, Haider KM, Siatkowski RM, Dean TW, Beck RW, Repka MX, Smith LE, Good WV, Kong L, Cotter SA, Holmes JM; Pediatric Eye Disease Investigator Group (PEDIG). Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jun 1;138(6):698-701. doi: 10.1001/jamaophthalmol.2020.0334.
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG002
Bevacizumab (0.063 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
FG00011 subjects
FG00116 subjects
FG00224 subjects
FG00310 subjects
FG00414 subjects
FG0059 subjects
FG00612 subjects
FG00724 subjects
COMPLETED
FG00011 subjects
FG00114 subjects
FG00224 subjects
FG0039 subjects
FG00413 subjects
FG0059 subjects
FG00610 subjects
FG00723 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
BG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
BG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
BG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
BG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
BG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
BG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
BG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab to be studied
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00116
BG00224
BG00310
BG00414
BG0059
BG00612
BG00724
BG008120
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Gestational Age in Weeks
Mean
Standard Deviation
Weeks
Title
Denominators
Categories
Gestational age at enrollment
Title
Measurements
BG00024.81± 1.49
BG00125.21± 2.22
BG00224.82± 1.42
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0007
BG00110
BG002
Birth Weight
Mean
Standard Deviation
grams
Title
Denominators
Categories
Title
Measurements
BG000726.27± 219.23
BG001801.31± 514.35
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Successful Treatment of ROP
Success is defined as improvement* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.
* For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity.
A dose will be considered effective if it successfully treats at least 80% of subjects.
Seven infants were excluded (4 infants died prior to 4-week outcome examination; 1 failed, but it was not confirmed by second examiner; 1 was injected with the wrong dose in the study eye; and 1 had the fellow eye treated in the absence of type 1 ROP within one week of the study eye).
Posted
Count of Participants
Participants
4 weeks post-injection
ID
Title
Description
OG000
Bevacizumab
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
Units
Counts
Participants
OG000113
Title
Denominators
Categories
0.250 mg Bevacizumab
ParticipantsOG00011
Title
Measurements
OG00011
0.125 mg Bevacizumab
ParticipantsOG000
Secondary
Distribution of VEGF Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of vascular endothelial growth factor (VEGF) and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
In this optional portion of the study, data is available for 66 infants.
Posted
Count of Participants
Participants
2 weeks post-injection
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.0125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Secondary
Distribution of VEGF Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
In this optional portion of the study, data is available for 61 infants.
Posted
Count of Participants
Participants
4 weeks post-injection
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.0125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Secondary
Distribution of Avastin Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
Given the optional nature of this blood draw, outcomes were only collected for 56 infants. Given small sample size, we combined all dose levels and reported for those who were enrolled in this optional portion of the study.
Posted
Median
Inter-Quartile Range
ng/mL
2 weeks post-injection
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
Secondary
Distribution of Avastin Levels
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
Given the optional nature of the blood draw and loss to follow up, 4 week data was only collected for 49 infants. Given small sample size, we combined all dose levels and reported for those who were enrolled in this optional portion of the study. Reporting the results overall matches the published MS.
Posted
Median
Inter-Quartile Range
ng/mL
4 weeks post-injection
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
Secondary
Number of Study Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Eyes, Seven enrolled study eyes and 11 enrolled fellow eyes missing from the table due to lack of 4-week follow-up, including death or deviation. Of these eyes, 5 study eyes and 4 fellow eyes were missing due to death. Eleven additional enrolled fellow eyes missing due to lack of need for initial injection.
Posted
Count of Participants
Participants
12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
Secondary
Any Adverse Events or Complications Since the 4-week Exam
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Posted
Count of Participants
Participants
12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
Secondary
Visual Fixation Status at 12 Months
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
8 Infants died before exam, exam not completed for 5 participants, and 16 patients were lost to follow up and did not complete.
Posted
Count of Participants
Participants
12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Bevacizumab (0.016 mg)
Secondary
Proportion of Infants for Whom at Least One Event Was Reported
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Posted
Count of Participants
Participants
Enrollment to 12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Secondary
Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Posted
Count of Participants
Participants
Enrollment to 12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.250 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG002
Bevacizumab (0.063 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
Secondary
Count of Infants for Whom at Least One Serious Adverse Event Was Reported
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method.
Posted
Count of Participants
Participants
Enrollment to 12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Bevacizumab (0.016 mg)
Secondary
Number of Infant Deaths
Adverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Posted
Count of Participants
Participants
Enrollment to 12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
Secondary
Number of Infants With 24-Month Extended Follow Up Exam
A subset of infants enrolled in ROP1 will have extended follow up consisting of one additional office exam with developmental testing.
This testing will provide a cross-sectional evaluation of visual acuity, refractive error, and development at the adjusted age 24-month visit.
24-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 24 months.
Posted
Count of Participants
Participants
24-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG004
Secondary
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Eyes, Seven enrolled study eyes and 11 enrolled fellow eyes missing from the table due to lack of 4-week follow-up, including death or deviation. Of these eyes, 5 study eyes and 4 fellow eyes were missing due to death. Eleven additional enrolled fellow eyes missing due to lack of need for initial injection.
Posted
Count of Participants
Participants
12-month corrected age
ID
Title
Description
OG000
Bevacizumab (0.625 mg)
Dosage of injected Bevacizumab to be studied
OG001
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
OG002
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
OG003
Bevacizumab (0.0625)
Dosage of injected Bevacizumab to be studied
Time Frame
1 Year
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Bevacizumab (0.25 mg)
Dosage of injected Bevacizumab to be studied
0
11
1
11
4
11
EG001
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
3
16
3
16
3
16
EG002
Bevacizumab (0.0625 mg)
Dosage of injected Bevacizumab to be studied
2
24
3
24
4
24
EG003
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
2
10
1
10
1
10
EG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
1
14
1
14
4
14
EG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
0
9
1
9
1
9
EG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
0
12
5
12
5
12
EG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab to be studied
1
24
4
24
9
24
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG0030 events0 affected10 at risk
EG004
Adrenal Insufficiency
Endocrine disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Apnoea Neonatal
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Blood Potassium increased
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Bronchiolitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Bronchopulmonary dysplasia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0013 events3 affected16 at risk
EG0023 events3 affected24 at risk
EG003
Cardiac Arrest
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Chronic Respiratory Disease
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Endocarditis
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Enterococcal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Feeding Intolerance
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Gastrointestinal tube insertion
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Gastrostomy
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Hepatic Failure
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 affected24 at risk
EG003
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Hypoxia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Infantile apnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Influenza
General disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Necrotising enterocolitis neonatal
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Penumonia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Penumonia Aspiration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Pulmonary Hypertension
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Pyloric stenosis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Respiratory tract infection
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Retinal Detachment
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0022 events1 affected24 at risk
EG003
Retinal neovascularisation
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Septic Shock
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Small Intestine Perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Tracheomalacia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Tricuspid valve disease
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0023 events3 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0022 events1 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Any Adverse Event
Eye disorders
Systematic Assessment
An adverse event is any untoward medical occurrence in a study participant, irrespective of whether or not the event is considered treatment-related.
EG0004 affected11 at risk
EG0013 affected16 at risk
EG0024 affected24 at risk
EG0031 affected10 at risk
EG004
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Apnoea neonatal
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Bacterameia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Bradycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Bronchopulmonary dysplasia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Candida infection
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Cataract cortical
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Cataract operation
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Cholangitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Clonus
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Congenital coronary artery malformation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Conjunctival haemorrhage
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0024 events2 affected24 at risk
EG003
Conjunctivitis
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Corneal Disorder
Eye disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Deafness
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0023 events2 affected24 at risk
EG003
Eye Discharge
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Feeding Intolerance
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Fungal Skin Infection
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Gastrointestinal tube insertion
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events2 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Haemangioma of Skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Hernia
General disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Hydrocele
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Hypocalcaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Hypoxia
General disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Infection
General disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Iris Adhesions
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Lacrimation Increased
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Laryngomalacia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Metabolic Alkalosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Penumonia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 events1 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Retinal Detachment
Eye disorders
Systematic Assessment
EG0002 events2 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Retinal Disorder
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Retinal Haemorrhage
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Retinal Vein Occlusion
Eye disorders
Systematic Assessment
EG0002 events1 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Retinopathy
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Seizure
Nervous system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Staphylococcal infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Thermal Burn
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Tracheomalacia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Urinary Tract infection
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0021 events1 affected24 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Vitreous haemorrhage
Eye disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0012 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected11 at risk
EG0011 events1 affected16 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Raymond Kraker, PEDIG Coordinating Center Director
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG004
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
OG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
Units
Counts
Participants
OG00011
OG00116
OG00224
OG00310
OG00414
OG0059
OG00612
OG00724
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
Dosage of injected Bevacizumab to be studied
OG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
OG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
OG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab to be studied
Units
Counts
Participants
OG00011
OG00116
OG00224
OG00310
OG00414
OG0059
OG00612
OG00724
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0023
OG0031
OG0041
OG0050
OG0065
OG0074
OG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
OG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
OG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab to be studied
Units
Counts
Participants
OG00011
OG00116
OG00224
OG00310
OG00414
OG0059
OG00612
OG00724
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0022
OG0032
OG0041
OG0050
OG0060
OG0071
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
OG005
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
OG006
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
OG007
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab to be studied
Units
Counts
Participants
OG00011
OG00116
OG00224
OG00310
OG00414
OG0059
OG00612
OG00724
Title
Denominators
Categories
Title
Measurements
OG0006
OG0018
OG00215
OG0037
OG00411
OG0056
OG0065
OG00712
OG004
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
OG005
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
OG006
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
OG007
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
Units
Counts
Participants
OG00010
OG00114
OG00221
OG0036
OG00410
OG0058
OG00611
OG00718
Title
Denominators
Categories
Additional Treatment Needed : Severe ROP: Initial Treatment Failure
Title
Measurements
OG0000
OG0010
OG0023
OG0030
OG0040
OG0051
OG0062
OG0071
Additional Treatment Needed : Severe ROP: Early Reactivation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Additional Treatment Needed : Severe ROP: Late Reactivation