Trial · NCT02390531
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
NCT02390531, Phase 1, Completed, Jaeb Center for Health Research; results first posted 2022-11-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity. Trials, record NCT02390531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02390531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
- NCT number
- NCT02390531
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 120 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Retinopathy of Prematurity
- Interventions
- Bevacizumab
- First posted
- 2015-03-17
- Last updated
- 2022-11-03
- Results first posted
- 2022-11-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Successful Treatment of ROP | 4 weeks post-injection | 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. |
| Secondary | Distribution of VEGF Levels | 2 weeks post-injection | 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. |
| Secondary | Distribution of VEGF Levels | 4 weeks post-injection | 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. |
| Secondary | Distribution of Avastin Levels | 2 weeks post-injection | 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. |
| Secondary | Distribution of Avastin Levels | 4 weeks post-injection | 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. |
| Secondary | Number of Study Eyes Requiring Additional Treatment/s for ROP | 12-month corrected age | 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months |
| Secondary | Any Adverse Events or Complications Since the 4-week Exam | 12-month corrected age | 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months |
| Secondary | Visual Fixation Status at 12 Months | 12-month corrected age | 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months |
| Secondary | Proportion of Infants for Whom at Least One Event Was Reported | Enrollment to 12-month corrected age | 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 |
| Secondary | Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug | Enrollment to 12-month corrected age | 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Successful Treatment of ROP | 4 weeks post-injection | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distribution of VEGF Levels | 2 weeks post-injection | In this optional portion of the study, data is available for 66 infants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distribution of VEGF Levels | 4 weeks post-injection | In this optional portion of the study, data is available for 61 infants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distribution of Avastin Levels | 2 weeks post-injection | 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. | ng/mL | MEDIAN |
| SECONDARY | Distribution of Avastin Levels | 4 weeks post-injection | 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. | ng/mL | MEDIAN |
| SECONDARY | Number of Study Eyes Requiring Additional Treatment/s for ROP | 12-month corrected age | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Any Adverse Events or Complications Since the 4-week Exam | 12-month corrected age | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Visual Fixation Status at 12 Months | 12-month corrected age | 8 Infants died before exam, exam not completed for 5 participants, and 16 patients were lost to follow up and did not complete. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Infants for Whom at Least One Event Was Reported | Enrollment to 12-month corrected age | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug | Enrollment to 12-month corrected age | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.250 mg Bevacizumab | 11 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.125 mg Bevacizumab | 14 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.063 mg Bevacizumab | 21 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.031 mg Bevacizumab | 9 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.016 mg Bevacizumab | 13 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.008 mg Bevacizumab | 9 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.004 mg Bevacizumab | 9 | Participants | |
| Number of Participants With Successful Treatment of ROP | Bevacizumab | 0.002 mg Bevacizumab | 17 | Participants | |
| Distribution of VEGF Levels | Bevacizumab (0.25 mg) | Any increase in VEGF | 0 | Participants | |
| Distribution of VEGF Levels | Bevacizumab (0.0125 mg) | Any increase in VEGF | 0 | Participants |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab (0.250 mg) | 11 | |
| Overall Study | STARTED | Bevacizumab (0.125 mg) | 16 | |
| Overall Study | STARTED | Bevacizumab (0.063 mg) | 24 | |
| Overall Study | STARTED | Bevacizumab (0.031 mg) | 10 | |
| Overall Study | STARTED | Bevacizumab (0.016 mg) | 14 | |
| Overall Study | STARTED | Bevacizumab (0.008 mg) | 9 | |
| Overall Study | STARTED | Bevacizumab (0.004 mg) | 12 | |
| Overall Study | STARTED | Bevacizumab (0.002 mg) | 24 | |
| Overall Study | COMPLETED | Bevacizumab (0.250 mg) | 11 | |
| Overall Study | COMPLETED | Bevacizumab (0.125 mg) | 14 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events800
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.25 mg) | 4 | 11 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.125 mg) | 3 | 16 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.0625 mg) | 4 | 24 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.031 mg) | 1 | 10 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.016 mg) | 4 | 14 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.008 mg) | 1 | 9 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.004 mg) | 5 | 12 | |
| other | Any Adverse Event | Eye disorders | Bevacizumab (0.002 mg) | 9 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab (0.25 mg) | 0 | 11 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Bevacizumab (0.125 mg) | 1 | 16 | 1 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab (0.25 mg) | 0 | 11 |
| Total, all-cause mortality | Bevacizumab (0.125 mg) | 3 | 16 |
| Total, all-cause mortality | Bevacizumab (0.0625 mg) | 2 | 24 |
| Total, all-cause mortality | Bevacizumab (0.031 mg) | 2 | 10 |
| Total, all-cause mortality | Bevacizumab (0.016 mg) | 1 | 14 |
| Total, all-cause mortality | Bevacizumab (0.008 mg) | 0 | 9 |
| Total, all-cause mortality | Bevacizumab (0.004 mg) | 0 | 12 |
| Total, all-cause mortality | Bevacizumab (0.002 mg) | 1 | 24 |
| Total, other adverse events | Bevacizumab (0.25 mg) | 4 | 11 |
| Total, other adverse events | Bevacizumab (0.125 mg) | 3 | 16 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY011751 | Pediatric Eye Disease Investigator Group Coordinating Center | KRAKER, RAYMOND | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 1997 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02390531
GET https://conductscience.org/api/trials/v1/NCT02390531/results?page=2