Trial Outcomes & Findings for Safety and Efficacy of Switching From Aflibercept to Ranibizumab in Patients With nAMD (NCT NCT02161575)
NCT ID: NCT02161575
Last Updated: 2019-02-15
Results Overview
Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
103 participants
Primary outcome timeframe
Baseline and Day 90
Results posted on
2019-02-15
Participant Flow
Patients were recruited from 22 sites located in the United Kingdom and 6 sites located in Germany. A total of 103 patients received at least 1 dose of study drug.
Of the 103 patients who received at least 1 dose of study drug, 3 patients did not have any post-baseline safety or CSRT assessments and were therefore excluded from the SAF and FAS, in accordance with the analysis set definitions. Therefore, 100 patients were included in the SAF and FAS.
Participant milestones
| Measure |
Ranibizumab
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
Full Analysis Set (FAS) Population
|
100
|
|
Overall Study
Safety (SAF) Population
|
100
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Ranibizumab
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Overall Study
Protocol Violation
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
FAS
Baseline characteristics by cohort
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Age, Continuous
|
77 years
STANDARD_DEVIATION 6.51 • n=93 Participants • FAS
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants • FAS
|
|
Sex: Female, Male
Male
|
45 Participants
n=93 Participants • FAS
|
|
Race/Ethnicity, Customized
Caucasian
|
99 Participants
n=93 Participants • FAS
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants • FAS
|
PRIMARY outcome
Timeframe: Baseline and Day 90Population: FAS - Missing values at Day 90 were imputed using Last Observation Carried Forward (LOCF) where possible. For the change from baseline, only patients with a value at both baseline and Day 90 were included.
Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=97 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.
Baseline
|
384.00 micrometer
Interval 154.0 to 975.0
|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.
Day 90
|
318.00 micrometer
Interval 170.0 to 832.0
|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.
Change from Baseline to Day 90
|
-30.75 micrometer
Interval -386.0 to 78.0
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Measurement of change in SRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180
SRT at Baseline
|
346.00 micrometer
Interval 69.0 to 944.5
|
|
Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180
SRT at Day 180
|
302.00 micrometer
Interval 41.5 to 876.5
|
|
Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180
SRT change from Baseline to Day 180
|
-23.50 micrometer
Interval -464.0 to 306.5
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Measurement of change in CSRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180
CSRT at Baseline
|
384.00 micrometer
Interval 154.0 to 975.0
|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180
CSRT at Day 180
|
343.00 micrometer
Interval 194.0 to 842.0
|
|
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180
CSRT change from Baseline to Day 180
|
-28.00 micrometer
Interval -271.0 to 171.0
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Measurement of change in CSRV from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180
CSRV at Baseline
|
0.3050 cubic micrometer
Interval 0.12 to 11.6
|
|
Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180
CSRV at Day 180
|
0.2750 cubic micrometer
Interval 0.115 to 11.4
|
|
Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180
CSRV change from Baseline to Day 180
|
-0.0200 cubic micrometer
Interval -1.6 to 0.135
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Presence or absence of qualitative OCT parameter Intraretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Baseline · Yes, Definitive
|
32 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Baseline · Yes, Subtle
|
11 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Baseline · No
|
56 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Baseline · Questionable
|
1 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Definitive
|
24 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Subtle
|
15 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Day 180 · No
|
55 Participants
|
|
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Day 180 · Questionable
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 180Population: FAS
Presence or absence of qualitative OCT parameter Subretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Baseline · Yes, Definitive
|
83 Participants
|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Baseline · Yes, Subtle
|
5 Participants
|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Baseline · No
|
12 Participants
|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Definitive
|
49 Participants
|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Subtle
|
15 Participants
|
|
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Day 180 · No
|
30 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Presence or absence of qualitative OCT parameter Intraretinal/Subretinal Fluid Within the Central Subfield. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Baseline · Yes, Definitive
|
38 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Baseline · Yes, Subtle
|
6 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Baseline · No
|
5 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Baseline · Questionable
|
1 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Baseline · NA
|
50 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Definitive
|
26 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Day 180 · Yes, Subtle
|
12 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Day 180 · No
|
15 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Day 180 · Questionable
|
1 Participants
|
|
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Day 180 · NA
|
40 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Presence or absence of qualitative OCT parameter Pigment Epithelial Detachments. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Baseline · Yes, Definitive
|
86 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Baseline · Yes, Subtle
|
2 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Baseline · No
|
12 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Baseline · Not gradable
|
0 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Day 180 · Yes, Definitive
|
80 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Day 180 · Yes, Subtle
|
4 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Day 180 · No
|
8 Participants
|
|
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Day 180 · Not gradable
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Presence or absence of qualitative OCT parameter Dry Retina. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Baseline · Yes, Definitive
|
0 Participants
|
|
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Baseline · No
|
100 Participants
|
|
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Day 180 · Yes, Definitive
|
0 Participants
|
|
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Day 180 · No
|
94 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Height. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Maximum PED Height From Baseline to Day 180
Baseline
|
236.00 micrometer
Interval 66.5 to 674.0
|
|
Change in Maximum PED Height From Baseline to Day 180
Day 180
|
203.50 micrometer
Interval 63.5 to 705.0
|
|
Change in Maximum PED Height From Baseline to Day 180
Change from Baseline to Day 180
|
-2.50 micrometer
Interval -336.5 to 131.0
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Diameter. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Maximum PED Diameter From Baseline to Day 180
Baseline
|
2205.00 micrometer
Interval 0.0 to 4877.0
|
|
Change in Maximum PED Diameter From Baseline to Day 180
Day 180
|
2428.00 micrometer
Interval 471.0 to 4683.0
|
|
Change in Maximum PED Diameter From Baseline to Day 180
Change from Baseline to Day 180
|
59.50 micrometer
Interval -1007.0 to 2756.0
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Change from Baseline to Day 180 in Maximum Intraretinal Cyst (IRC) Height. Data collected on the study eye were used for the evaluation of efficacy.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Maximum IRC Height From Baseline to Day 180
Baseline
|
121.50 micrometer
Interval 21.0 to 280.5
|
|
Change in Maximum IRC Height From Baseline to Day 180
Day 180
|
105.50 micrometer
Interval 25.5 to 485.0
|
|
Change in Maximum IRC Height From Baseline to Day 180
Change from Baseline to Day 180
|
0.00 micrometer
Interval -223.5 to 235.0
|
SECONDARY outcome
Timeframe: Baseline, Day 90 and Day 180Population: FAS
BCVA was assessed as letters read and measured in a sitting position using subjective refraction and Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline
|
71.5 letters
Interval 36.0 to 90.0
|
|
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Day 90
|
74.0 letters
Interval 32.0 to 87.0
|
|
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Day 180
|
75.0 letters
Interval 32.0 to 90.0
|
|
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Baseline to Day 180
|
1.0 letters
Interval -31.0 to 35.0
|
|
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Change from Day 90 to Day 180
|
0.0 letters
Interval -25.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: FAS
Number of patients gaining at least 15 letters from Baseline to Day 180
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
>=15 (Gain of at least 15 letters)
|
11 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
10 to <15
|
6 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
5 to <10
|
17 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
0 to <5
|
25 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
>-15 to <0
|
31 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
<=-15 (Loss of at least 15 letters)
|
7 Participants
|
|
Change in ETDRS Letters for Study Eye From Baseline to Day 180
NA
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 180Population: SAF
Incidence of ocular Treatment Emergent Adverse Events (TEAEs) in the study eye reported by ≥2% patients by preferred term.
Outcome measures
| Measure |
Ranibizumab
n=100 Participants
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Eye pain
|
3 Participants
|
|
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Visual impairment
|
3 Participants
|
|
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Blepharitis
|
2 Participants
|
|
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Posterior capsule opacification
|
2 Participants
|
|
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Intraocular pressure increased
|
3 Participants
|
Adverse Events
Ranibizumab
Serious events: 10 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab
n=100 participants at risk
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Gastrointestinal disorders
VOMITING
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Infections and infestations
PNEUMONIA
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Injury, poisoning and procedural complications
FALL
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
CATHETERISATION CARDIAC
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Surgical and medical procedures
UMBILICAL HERNIA REPAIR
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Surgical and medical procedures
VAGINAL PROLAPSE REPAIR
|
1.0%
1/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
Other adverse events
| Measure |
Ranibizumab
n=100 participants at risk
All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
BLEPHARITIS
|
6.0%
6/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
DRY EYE
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
EYE PAIN
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
POSTERIOR CAPSULE OPACIFICATION
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
General disorders
FATIGUE
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Infections and infestations
CYSTITIS
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
7.0%
7/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.0%
9/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
4.0%
4/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
HEART RATE DECREASED
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Investigations
WEIGHT DECREASED
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Nervous system disorders
DIZZINESS
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Nervous system disorders
HEADACHE
|
3.0%
3/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.0%
7/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
|
Vascular disorders
HYPERTENSION
|
2.0%
2/100 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 6 months.
Ocular AEs are reported for the study eye and non-study eye combined.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER