Trial Outcomes & Findings for A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (NCT NCT03834753)
NCT ID: NCT03834753
Last Updated: 2026-08-03
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
228 participants
Primary outcome timeframe
11 months
Results posted on
2026-08-03
Participant Flow
Participant milestones
| Measure |
Bevacizumab
ONS-5010
|
Ranibizumab
ranibizumab
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
115
|
|
Overall Study
COMPLETED
|
103
|
95
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=113 Participants
ONS-5010
|
Ranibizumab
n=115 Participants
ranibizumab
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
78.8 years
STANDARD_DEVIATION 8.30 • n=20 Participants
|
79.1 years
STANDARD_DEVIATION 8.49 • n=20 Participants
|
78.9 years
STANDARD_DEVIATION 8.38 • n=40 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=20 Participants
|
69 Participants
n=20 Participants
|
136 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
92 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=20 Participants
|
113 Participants
n=20 Participants
|
223 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 11 monthsBCVA 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 |
Bevacizumab
n=108 Participants
ONS-5010
|
Ranibizumab
n=104 Participants
ranibizumab
|
|---|---|---|
|
Proportion of Subjects Who Gain 15 or More Letters in Best Corrected Visual Acuity (BCVA)
|
45 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 11 monthsBCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Outcome measures
| Measure |
Bevacizumab
n=104 Participants
ONS-5010
|
Ranibizumab
n=96 Participants
ranibizumab
|
|---|---|---|
|
Mean Change in the Best Corrected Visual Acuity
|
11.2 letters
Standard Deviation 12.19
|
5.8 letters
Standard Deviation 14.80
|
SECONDARY outcome
Timeframe: 11 monthsBCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Outcome measures
| Measure |
Bevacizumab
n=108 Participants
ONS-5010
|
Ranibizumab
n=104 Participants
ranibizumab
|
|---|---|---|
|
Proportion of Participants Who Gain at Least 10 Letters in the Best Corrected Visual Acuity
|
61 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 11 monthsBCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity.
Outcome measures
| Measure |
Bevacizumab
n=108 Participants
ONS-5010
|
Ranibizumab
n=104 Participants
ranibizumab
|
|---|---|---|
|
Proportion of Participants Who Gain at Least 5 Letters in the Best Corrected Visual Acuity
|
74 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 11 monthsBCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity.
Outcome measures
| Measure |
Bevacizumab
n=108 Participants
ONS-5010
|
Ranibizumab
n=104 Participants
ranibizumab
|
|---|---|---|
|
Proportion of Participants Who Lose Fewer Than 15 Letters in the Best Corrected Visual Acuity
|
101 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 11 monthsOutcome measures
| Measure |
Bevacizumab
n=108 Participants
ONS-5010
|
Ranibizumab
n=104 Participants
ranibizumab
|
|---|---|---|
|
Proportion of Participants With Visual-acuity Snellen Equivalent of 20/200 or Worse
|
14 Participants
|
25 Participants
|
Adverse Events
Bevacizumab
Serious events: 14 serious events
Other events: 31 other events
Deaths: 3 deaths
Ranibizumab
Serious events: 16 serious events
Other events: 34 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bevacizumab
n=113 participants at risk
ONS-5010
|
Ranibizumab
n=115 participants at risk
ranibizumab
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Cardiac disorders
Aortic valve stenosis
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Cardiac disorders
Bundle branch block
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
General disorders
Cardiac death
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
General disorders
Death
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Infections and infestations
COVID-19
|
0.88%
1/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Infections and infestations
Clostridium difficile infection
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Investigations
Intraocular pressure increased
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Nervous system disorders
Confusional state
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
|
Vascular disorders
Epistaxis
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
|
Vascular disorders
Transient ischaemic attack
|
0.88%
1/113 • from enrollment to 12 months
|
0.00%
0/115 • from enrollment to 12 months
|
Other adverse events
| Measure |
Bevacizumab
n=113 participants at risk
ONS-5010
|
Ranibizumab
n=115 participants at risk
ranibizumab
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
8.8%
10/113 • from enrollment to 12 months
|
2.6%
3/115 • from enrollment to 12 months
|
|
Eye disorders
Retinal haemorrhage
|
2.7%
3/113 • from enrollment to 12 months
|
7.0%
8/115 • from enrollment to 12 months
|
|
Eye disorders
Visual acuity reduced
|
2.7%
3/113 • from enrollment to 12 months
|
14.8%
17/115 • from enrollment to 12 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
8/113 • from enrollment to 12 months
|
4.3%
5/115 • from enrollment to 12 months
|
|
Investigations
Intraocular pressure increased
|
6.2%
7/113 • from enrollment to 12 months
|
0.87%
1/115 • from enrollment to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60