A Phase 1 interventional study of Bevacizumab in Retinopathy of Prematurity, sponsored by Jaeb Center for Health Research. Completed at 11 sites in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Jaeb Center for Health Research · Phase 1, Interventional, and Treatment
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.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Type 1 ROP; defined as:
Exclusion Criteria:
The following exclusions apply to the study eye:
If purulent ocular discharge is present in either eye, then the infant is ineligible.
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Dosage of injected Bevacizumab to be studied
Drug: Bevacizumab
Varying dosages in 10µl
Also known as: Avastin
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.
Time frame: 4 weeks post-injection
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.
Time frame: 2 weeks post-injection
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 12-month corrected age
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.
| Milestone | Bevacizumab (0.250 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.063 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Started | 11 | 16 | 24 | 10 | 14 | 9 | 12 | 24 |
| Completed | 11 | 14 | 24 | 9 | 13 | 9 | 10 | 23 |
| Not completed | 0 | 2 | 0 | 1 | 1 | 0 | 2 | 1 |
| Withdrew: Death | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 |
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.
| Participants | Bevacizumab |
|---|---|
| 0.250 mg Bevacizumab | 11 |
| 0.125 mg Bevacizumab | 14 |
| 0.063 mg Bevacizumab | 21 |
| 0.031 mg Bevacizumab | 9 |
| 0.016 mg Bevacizumab | 13 |
| 0.008 mg Bevacizumab | 9 |
| 0.004 mg Bevacizumab | 9 |
| 0.002 mg Bevacizumab | 17 |
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.
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.0125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Any increase in VEGF | 0 | 0 | 4 | 0 | 2 | 0 | 4 | 1 |
| Decrease in VEGF by 1% to <25% | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Decrease in VEGF by 25% to <50% | 4 | 2 | 2 | 1 | 1 | 0 | 0 | 1 |
| Decrease in VEGF by greater than or equal to 50% | 3 | 8 | 9 | 6 | 6 | 5 | 0 | 3 |
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.
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.0125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Any increase in VEGF | 1 | 0 | 2 | 1 | 2 | 1 | 4 | 3 |
| Decrease in VEGF by 1% to <25% | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Decrease in VEGF by 25% to <50% | 3 | 2 | 3 | 1 | 1 | 1 | 0 | 0 |
| Decrease in VEGF by greater than or equal to 50% | 3 | 7 | 7 | 4 | 4 | 4 | 0 | 2 |
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.
| ng/mL | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Distribution of Avastin Levels | 364 (264 to 424) | 231 (167 to 324) | 292 (111 to 379) | 167 (98 to 274) | 79 (66 to 95) | — | — | — |
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.
| ng/mL | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Distribution of Avastin Levels | 281 (242 to 401) | 196 (118 to 258) | 254 (254 to 427) | 115 (81 to 275) | 67 (54 to 99) | — | — | — |
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Additional Treatment Needed : Severe ROP: Initial Treatment Failure | 0 | 0 | 3 | 0 | 0 | 0 | 1 | 2 |
| Additional Treatment Needed : Severe ROP: Early Reactivation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| Additional Treatment Needed : Severe ROP: Late Reactivation | 2 | 4 | 5 | 0 | 4 | 3 | 3 | 0 |
| Additional Treatment Needed : Persistent Avascular Retina | 3 | 2 | 3 | 3 | 8 | 2 | 1 | 9 |
| No Additional Treatment | 6 | 8 | 13 | 6 | 1 | 4 | 5 | 8 |
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Any Adverse Events or Complications Since the 4-week Exam | 4 | 3 | 4 | 1 | 4 | 1 | 5 | 9 |
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Central Fixation in Both Eyes | 9 | 13 | 16 | 6 | 11 | 8 | 10 | 12 |
| Central Fixation in One Eye | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| No Central Fixation in either eye | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 2 |
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
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Proportion of Infants for Whom at Least One Event Was Reported | 6 | 4 | 5 | 1 | 5 | 1 | 5 | 11 |
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
| Participants | Bevacizumab (0.250 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.063 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
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.
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Count of Infants for Whom at Least One Serious Adverse Event Was Reported | 4 | 2 | 3 | 1 | 1 | 0 | 5 | 4 |
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
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Number of Infant Deaths | 0 | 2 | 2 | 2 | 1 | 0 | 0 | 1 |
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.
| Participants | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Number of Infants With 24-Month Extended Follow Up Exam | 6 | 8 | 15 | 7 | 11 | 6 | 5 | 12 |
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
| Participants | Bevacizumab (0.625 mg) | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) |
|---|---|---|---|---|---|---|---|---|
| Additional Treatment Needed : Severe ROP: Initial Treatment Failure | 0 | 0 | 3 | 0 | 0 | 1 | 2 | 1 |
| Additional Treatment Needed : Severe ROP: Early Reactivation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Additional Treatment Needed : Severe ROP: Late Reactivation | 2 | 3 | 5 | 0 | 2 | 2 | 2 | 2 |
| Additional Treatment Needed : Persistent Avascular Retina | 3 | 3 | 2 | 2 | 7 | 2 | 2 | 8 |
| No Additional Treatment | 5 | 8 | 11 | 4 | 1 | 3 | 5 | 6 |
Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab (0.25 mg) | 0/11 (0%) | 1/11 (9.1%) | 4/11 (36.4%) |
| Bevacizumab (0.125 mg) | 3/16 (18.8%) | 3/16 (18.8%) | 3/16 (18.8%) |
| Bevacizumab (0.0625 mg) | 2/24 (8.3%) | 3/24 (12.5%) | 4/24 (16.7%) |
| Bevacizumab (0.031 mg) | 2/10 (20%) | 1/10 (10%) | 1/10 (10%) |
| Bevacizumab (0.016 mg) | 1/14 (7.1%) | 1/14 (7.1%) | 4/14 (28.6%) |
| Bevacizumab (0.008 mg) | 0/9 (0%) | 1/9 (11.1%) | 1/9 (11.1%) |
| Bevacizumab (0.004 mg) | 0/12 (0%) | 5/12 (41.7%) | 5/12 (41.7%) |
| Bevacizumab (0.002 mg) | 1/24 (4.2%) | 4/24 (16.7%) | 9/24 (37.5%) |
| Event | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 0/11 | 0/16 | 0/24 | 0/10 | 0/14 | 0/9 | 4/12 | 2/24 |
| Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders | 0/11 | 3/16 | 3/24 | 1/10 | 0/14 | 0/9 | 0/12 | 1/24 |
| Infantile apnoeaRespiratory, thoracic and mediastinal disorders | 0/11 | 2/16 | 0/24 | 0/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Upper respiratory tract infectionInfections and infestations | 0/11 | 0/16 | 3/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Enterococcal infectionInfections and infestations | 0/11 | 0/16 | 0/24 | 0/10 | 0/14 | 1/9 | 0/12 | 1/24 |
| Small Intestine PerforationGastrointestinal disorders | 0/11 | 0/16 | 0/24 | 0/10 | 0/14 | 1/9 | 0/12 | 0/24 |
| BronchiolitisInfections and infestations | 0/11 | 0/16 | 0/24 | 1/10 | 0/14 | 0/9 | 1/12 | 1/24 |
| DysphagiaGastrointestinal disorders | 0/11 | 0/16 | 0/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Hepatic FailureGastrointestinal disorders | 0/11 | 0/16 | 0/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Pyloric stenosisGastrointestinal disorders | 0/11 | 0/16 | 0/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Event | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) |
|---|---|---|---|---|---|---|---|---|
| Any Adverse EventEye disorders | 4/11 | 3/16 | 4/24 | 1/10 | 4/14 | 1/9 | 5/12 | 9/24 |
| Feeding IntoleranceGastrointestinal disorders | 2/11 | 0/16 | 1/24 | 0/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Retinal DetachmentEye disorders | 2/11 | 0/16 | 0/24 | 0/10 | 1/14 | 0/9 | 0/12 | 1/24 |
| Retinal HaemorrhageEye disorders | 0/11 | 0/16 | 0/24 | 0/10 | 2/14 | 1/9 | 0/12 | 1/24 |
| Gastroesophageal reflux diseaseGastrointestinal disorders | 0/11 | 2/16 | 1/24 | 0/10 | 0/14 | 0/9 | 1/12 | 0/24 |
| Supraventricular extrasystolesCardiac disorders | 0/11 | 0/16 | 0/24 | 0/10 | 0/14 | 1/9 | 0/12 | 0/24 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/11 | 0/16 | 0/24 | 0/10 | 0/14 | 1/9 | 0/12 | 0/24 |
| Congenital coronary artery malformationCardiac disorders | 0/11 | 0/16 | 0/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Conjunctival haemorrhageEye disorders | 0/11 | 1/16 | 2/24 | 1/10 | 0/14 | 0/9 | 1/12 | 1/24 |
| ConjunctivitisEye disorders | 0/11 | 1/16 | 0/24 | 1/10 | 0/14 | 0/9 | 0/12 | 0/24 |
| Age, Continuous(Weeks) | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gestational age at enrollment | 24.81 ± 1.49 | 25.21 ± 2.22 | 24.82 ± 1.42 | 24.73 ± 1.12 | 24.48 ± 1.14 | 24.63 ± 1.48 | 24.45 ± 1.23 | 25.14 ± 2.02 | 24.84 ± 1.61 |
| Sex: Female, Male(Participants) | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 6 | 4 | 12 | 4 | 3 | 7 | 3 | 10 | 49 |
| Male | 5 | 12 | 12 | 6 | 11 | 2 | 9 | 14 | 71 |
| Race/Ethnicity, Customized(Participants) | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| White | 7 | 10 | 12 | 2 | 9 | 3 | 7 | 15 | 65 |
| Black/African American | 2 | 2 | 3 | 4 | 2 | 2 | 2 | 2 | 19 |
| Hispanic or Latino | 2 | 3 | 3 | 2 | 2 | 1 | 2 | 2 | 17 |
| Asian | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 0 | 5 |
| Native Hawaiian/Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| American Indian/Alaskan Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 |
| More than 1 race | 0 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 4 |
| Unknown/Not Reported | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 3 | 7 |
| Birth Weight(grams) | Bevacizumab (0.25 mg) | Bevacizumab (0.125 mg) | Bevacizumab (0.0625 mg) | Bevacizumab (0.031 mg) | Bevacizumab (0.016 mg) | Bevacizumab (0.008 mg) | Bevacizumab (0.004 mg) | Bevacizumab (0.002 mg) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 726.27 ± 219.23 | 801.31 ± 514.35 | 652.08 ± 156.88 | 680.60 ± 167.17 | 677.93 ± 147.02 | 539.44 ± 133.19 | 624.67 ± 155.14 | 722.00 ± 357.65 | 686.97 ± 281.43 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jaeb Center for Health Research