Trial Outcomes & Findings for Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD (NCT NCT04690556)
NCT ID: NCT04690556
Last Updated: 2026-01-29
Results Overview
Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
Baseline and 12 Months
Results posted on
2026-01-29
Participant Flow
\[Not Specified\]
\[Not Specified\]
Participant milestones
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Overall Study
STARTED
|
299
|
301
|
|
Overall Study
COMPLETED
|
256
|
269
|
|
Overall Study
NOT COMPLETED
|
43
|
32
|
Reasons for withdrawal
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
25
|
17
|
|
Overall Study
Prohibited medications and other reasons
|
3
|
1
|
Baseline Characteristics
Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD
Baseline characteristics by cohort
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=299 Participants
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=301 Participants
0.5 mg via intravitreal injection once monthly
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 8.75 • n=35 Participants
|
73.5 years
STANDARD_DEVIATION 7.90 • n=4328 Participants
|
73.3 years
STANDARD_DEVIATION 8.33 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=35 Participants
|
146 Participants
n=4328 Participants
|
297 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=35 Participants
|
155 Participants
n=4328 Participants
|
303 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Asian
|
158 Participants
n=35 Participants
|
147 Participants
n=4328 Participants
|
305 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=35 Participants
|
153 Participants
n=4328 Participants
|
294 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 MonthsPopulation: Full Analysis Set
Early treatment diabetic retinopathy study (ETDRS) charts were used for visual acuity measurement
Outcome measures
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=295 Participants
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=296 Participants
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months
|
11.17 Letters
Standard Error 0.689
|
11.14 Letters
Standard Error 0.680
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Full Analysis Set
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Outcome measures
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=295 Participants
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=296 Participants
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months
|
7.3 Letters
Standard Deviation 8.38
|
6.6 Letters
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Full Analysis Set
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Outcome measures
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=295 Participants
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=296 Participants
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months
|
9.5 Letters
Standard Deviation 9.67
|
8.7 Letters
Standard Deviation 10.35
|
SECONDARY outcome
Timeframe: Baseline and 9 MonthsPopulation: Full Analysis Set
ETDRS charts were used for visual acuity measurement summarized descriptively by treatment arm and time point
Outcome measures
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=295 Participants
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=296 Participants
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months
|
10.6 Letters
Standard Deviation 11.36
|
10.4 Letters
Standard Deviation 10.62
|
Adverse Events
LUBT010 (Proposed Ranibizumab Biosimilar)
Serious events: 26 serious events
Other events: 21 other events
Deaths: 3 deaths
Lucentis (Ranibizumab)
Serious events: 23 serious events
Other events: 26 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=299 participants at risk
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=301 participants at risk
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
2/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Cardiac failure acute
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Eye disorders
Macular hole
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
General disorders
Chest pain
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
Endophthalmitis
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
COVID-19
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
Sepsis
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Investigations
Tuberculin test positive
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Nervous system disorders
Syncope
|
0.67%
2/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Nervous system disorders
Ischaemic stroke
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Vascular disorders
Hypertension
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Vascular disorders
Orthostatic hypotension
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Vascular disorders
Varicose vein
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.33%
1/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.00%
0/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
0.33%
1/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
Other adverse events
| Measure |
LUBT010 (Proposed Ranibizumab Biosimilar)
n=299 participants at risk
0.5 mg via intravitreal injection once monthly
|
Lucentis (Ranibizumab)
n=301 participants at risk
0.5 mg via intravitreal injection once monthly
|
|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
7.0%
21/299 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
8.6%
26/301 • AE reporting extended from date of informed consent until Month 12 (EOS visit)
All AEs (ocular or non-ocular) were recorded. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity after at least 1 dose of study drug was administered.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place