Trial Outcomes & Findings for A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders (NCT NCT04516278)
NCT ID: NCT04516278
Last Updated: 2026-07-17
Results Overview
Number of participants with adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
197 participants
Primary outcome timeframe
3 months
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
Biological: Bevacizumab
ONS-5010
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
COMPLETED
|
192
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Baseline characteristics by cohort
| Measure |
Biological: Bevacizumab
n=197 Participants
ONS-5010
|
|---|---|
|
Age, Customized
Age at Screening
|
66.2 years
STANDARD_DEVIATION 13.47 • n=20 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants with adverse events
Outcome measures
| Measure |
Biological: Bevacizumab
n=197 Participants
ONS-5010
|
|---|---|
|
Number of Participants With Adverse Events
|
62 Participants
|
Adverse Events
Biological: Bevacizumab
Serious events: 11 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Biological: Bevacizumab
n=197 participants at risk
ONS-5010
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Eye disorders
Retinal hemorrhage
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Cellulitis
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Sepsis
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.51%
1/197 • from enrollment until end of follow-up, up to 12 weeks
|
Other adverse events
| Measure |
Biological: Bevacizumab
n=197 participants at risk
ONS-5010
|
|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
2.0%
4/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
COVID-19
|
3.6%
7/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.1%
8/197 • from enrollment until end of follow-up, up to 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
4/197 • from enrollment until end of follow-up, up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60