Trial Outcomes & Findings for Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion (NCT NCT01427751)
NCT ID: NCT01427751
Last Updated: 2019-04-18
Results Overview
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
307 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2019-04-18
Participant Flow
Participant milestones
| Measure |
Ozurdex®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
153
|
|
Overall Study
COMPLETED
|
112
|
139
|
|
Overall Study
NOT COMPLETED
|
42
|
14
|
Reasons for withdrawal
| Measure |
Ozurdex®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
2
|
|
Overall Study
No further treatment benefit expected
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal of consent
|
2
|
2
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Other miscellaneous reasons
|
6
|
4
|
Baseline Characteristics
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.58 • n=93 Participants
|
65.5 years
STANDARD_DEVIATION 12.04 • n=4 Participants
|
67.0 years
STANDARD_DEVIATION 11.41 • n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
128 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Change from Baseline at Month 12 (n=153,151)
|
7.9 letters
Standard Deviation 14.42
|
16.9 letters
Standard Deviation 12.08
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Baseline (n=153,153)
|
56.6 letters
Standard Deviation 10.89
|
59.2 letters
Standard Deviation 10.92
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
Baseline (n=149, 149)
|
553.2 microns
Standard Deviation 170.15
|
561.0 microns
Standard Deviation 188.93
|
|
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
Change from Baseline at Month 12 (n=140,144)
|
-219.2 microns
Standard Deviation 180.51
|
-253.5 microns
Standard Deviation 197.08
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Percentage of Patients With 15-or-More Letter Improvement in BCVA
|
33.8 percentage of participants
|
59.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
|
9.1 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Time to BCVA Improvement of 15-or-More Letters
|
73.7 days
Standard Deviation 79.68
|
82.0 days
Standard Deviation 93.78
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Baseline (n=143,139)
|
78.1 score on a scale
Standard Deviation 16.58
|
80.7 score on a scale
Standard Deviation 14.34
|
|
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Change from Baseline at Month 12 (n=143, 139)
|
3.5 score on a scale
Standard Deviation 12.21
|
6.6 score on a scale
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Intent-to-treat population included all randomized participants.
Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Outcome measures
| Measure |
Ozurdex®
n=154 Participants
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=153 Participants
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
|
4.5 percentage of participants
|
0.7 percentage of participants
|
Adverse Events
Ozurdex®
Serious events: 12 serious events
Other events: 127 other events
Deaths: 0 deaths
Lucentis®
Serious events: 16 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ozurdex®
n=153 participants at risk
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=150 participants at risk
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Agitated depression
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Confusional state
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Chest pain
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Ocular hypertension
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.65%
1/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Ozurdex®
n=153 participants at risk
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
|
Lucentis®
n=150 participants at risk
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
18.3%
28/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
11.3%
17/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Macular oedema
|
13.1%
20/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.7%
4/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Visual acuity reduced
|
11.8%
18/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.0%
3/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Cataract
|
8.5%
13/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
1.3%
2/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Lenticular opacities
|
6.5%
10/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Ocular hypertension
|
5.9%
9/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.67%
1/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Blepharitis
|
5.9%
9/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
2.0%
3/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Dry eye
|
5.9%
9/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
4.7%
7/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Vitreous floaters
|
5.9%
9/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.0%
9/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Eye pain
|
3.9%
6/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.0%
9/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Eye disorders
Conjunctivitis
|
3.9%
6/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.0%
9/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Investigations
Intraocular pressure increased
|
32.7%
50/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
10.7%
16/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
8/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
5/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Headache
|
2.6%
4/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.0%
9/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Vascular disorders
Hypertension
|
3.3%
5/153 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.7%
10/150 • Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER