Phase 1
Completed N=120
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Source: ClinicalTrials.gov NCT02390531 ↗Enrolled (actual)
120
Serious AEs
15.8%
Results posted
Nov 2022
Primary outcomePrimary: Number of Participants With Successful Treatment of ROP — 11; 14; 21; 9 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Treatment of ROP |
11; 14; 21; 9; 13; 9 | — |
| SECONDARY Distribution of VEGF Levels |
1; 0; 2; 1; 2; 1 | — |
| SECONDARY Distribution of Avastin Levels |
281; 196; 254; 115; 67 | — |
| SECONDARY Number of Study Eyes Requiring Additional Treatment/s for ROP |
0; 0; 3; 0; 0; 0 | — |
| SECONDARY Any Adverse Events or Complications Since the 4-week Exam |
4; 3; 4; 1; 4; 1 | — |
| SECONDARY Visual Fixation Status at 12 Months |
9; 13; 16; 6; 11; 8 | — |
| SECONDARY Proportion of Infants for Whom at Least One Event Was Reported |
6; 4; 5; 1; 5; 1 | — |
| SECONDARY Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Count of Infants for Whom at Least One Serious Adverse Event Was Reported |
4; 2; 3; 1; 1; 0 | — |
| SECONDARY Number of Infant Deaths |
0; 2; 2; 2; 1; 0 | — |
| SECONDARY Number of Infants With 24-Month Extended Follow Up Exam |
6; 8; 15; 7; 11; 6 | — |
| SECONDARY Number of Fellow Eyes Requiring Additional Treatment/s for ROP |
0; 0; 3; 0; 0; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02390531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.