Trial · NCT04634604
A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
NCT04634604, Phase 3, Terminated, Jaeb Center for Health Research; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP. Trials, record NCT04634604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04634604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP
- NCT number
- NCT04634604
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Retinopathy of Prematurity
- Interventions
- Bevacizumab, Laser
- First posted
- 2020-11-18
- Last updated
- 2026-09-14
- Results first posted
- 2024-08-01
- Limitations and caveats
- Early termination leading to small numbers of subjects which precluded statistical analysis. Active participants were released from study at time of study termination.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Success Rate At 6 Months Adjusted Age | 6 Months Adjusted Age | The primary objective for the randomized trial is to determine if infants with type 1 ROP treated with intravitreal bevacizumab (subsequently referred to as BV) have a treatment success rate determined at 6 months adjusted age that is non-inferior compared with infants treated with laser photocoagulation (subsequently referred to as LASER). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Success Rate At 6 Months Adjusted Age | 6 Months Adjusted Age | Study terminated due to lack of feasibility of recruitment. No analyses conducted due to lack of power for analysis given small sample size. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Success Rate At 6 Months Adjusted Age | Bevacizumab | 3 | Participants | ||
| Treatment Success Rate At 6 Months Adjusted Age | Laser | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Laser | 9 | |
| Overall Study | STARTED | Bevacizumab | 7 | |
| Overall Study | COMPLETED | Laser | 9 | |
| Overall Study | COMPLETED | Bevacizumab | 7 | |
| Overall Study | NOT COMPLETED | Laser | 0 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 0 |
Source ClinicalTrials.gov
Adverse events64
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 | Corneal edema | Eye disorders | Bevacizumab | 1 | 7 | 1 |
| other | Corneal edema | Eye disorders | Laser | 0 | 9 | 0 |
| other | Esotropia | Eye disorders | Bevacizumab | 1 | 7 | 1 |
| other | Esotropia | Eye disorders | Laser | 0 | 9 | 0 |
| other | Myopia | Eye disorders | Bevacizumab | 1 | 7 | 2 |
| other | Myopia | Eye disorders | Laser | 0 | 9 | 0 |
| other | Preretinal Hemorrhage | Eye disorders | Bevacizumab | 0 | 7 | 0 |
| other | Preretinal Hemorrhage | Eye disorders | Laser | 2 | 9 | 3 |
| other | Retinal Hemorrhage | Eye disorders | Bevacizumab | 0 | 7 | 0 |
| other | Retinal Hemorrhage | Eye disorders | Laser | 1 | 9 | 1 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | 0 | 7 |
| Total, all-cause mortality | Laser | 0 | 9 |
| Total, other adverse events | Bevacizumab | 4 | 7 |
| Total, other adverse events | Laser | 6 | 9 |
| Total, serious adverse events | Bevacizumab | 1 | 7 |
| Total, serious adverse events | Laser | 4 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| UG1EY011751 | Pediatric Eye Disease Investigator Group Coordinating Center | KRAKER, RAYMOND; PINELES, STACY; WEISE, KATHERINE K | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 2019 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bevacizumab vs Laser: Treatment Success Rate At 6 Months Adjusted Age | Trial comparisons |
| Bevacizumab vs Laser: deaths from any cause | Trial comparisons |
| Bevacizumab vs Laser: serious adverse events | Trial comparisons |
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/NCT04634604
GET https://conductscience.org/api/trials/v1/NCT04634604/events?page=2