Trial Outcomes & Findings for A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (NCT NCT06190093)
NCT ID: NCT06190093
Last Updated: 2026-07-23
Results Overview
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
ONS-5010 Bevacizumab
ONS-5010
|
Ranibizumab
ranibizumab
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
194
|
199
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
ONS-5010 Bevacizumab
n=200 Participants
ONS-5010
|
Ranibizumab
n=200 Participants
ranibizumab
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.6 years
STANDARD_DEVIATION 7.74 • n=9 Participants
|
77.8 years
STANDARD_DEVIATION 7.73 • n=27 Participants
|
78.2 years
STANDARD_DEVIATION 7.73 • n=267 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=9 Participants
|
115 Participants
n=27 Participants
|
248 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=9 Participants
|
85 Participants
n=27 Participants
|
152 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=9 Participants
|
195 Participants
n=27 Participants
|
389 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksBCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Outcome measures
| Measure |
ONS-5010 Bevacizumab
n=197 Participants
ONS-5010
|
Ranibizumab
n=198 Participants
ranibizumab
|
|---|---|---|
|
Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8
|
63.0 letters
Standard Deviation 13.5
|
66.2 letters
Standard Deviation 12.6
|
Adverse Events
ONS-5010 Bevacizumab
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ONS-5010 Bevacizumab
n=200 participants at risk
ONS-5010
|
Ranibizumab
n=200 participants at risk
ranibizumab
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Nervous system disorders
Basal ganglia stroke
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Appendicitis
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Eye disorders
Iridocyclitis
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.50%
1/200 • from enrollment until end of follow-up, up to 12 weeks
|
0.00%
0/200 • from enrollment until end of follow-up, up to 12 weeks
|
Other adverse events
| Measure |
ONS-5010 Bevacizumab
n=200 participants at risk
ONS-5010
|
Ranibizumab
n=200 participants at risk
ranibizumab
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
7.0%
14/200 • from enrollment until end of follow-up, up to 12 weeks
|
1.5%
3/200 • from enrollment until end of follow-up, up to 12 weeks
|
|
Vascular disorders
Hypertension
|
5.0%
10/200 • from enrollment until end of follow-up, up to 12 weeks
|
1.0%
2/200 • 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