Trial Outcomes & Findings for SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (NCT NCT00331864)
NCT ID: NCT00331864
Last Updated: 2011-02-18
Results Overview
Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
531 participants
Primary outcome timeframe
Baseline through end of study (12 month treatment period)
Results posted on
2011-02-18
Participant Flow
The study population consisted of two groups, one group being naïve to ranibizumab ("Non-ANCHOR" patients) and the other group were those patients who previously were treated with ranibizumab in the ANCHOR study (NCT00061594; "ANCHOR" patients).
Participant milestones
| Measure |
Ranibizumab Non-ANCHOR
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
513
|
18
|
|
Overall Study
COMPLETED
|
455
|
14
|
|
Overall Study
NOT COMPLETED
|
58
|
4
|
Reasons for withdrawal
| Measure |
Ranibizumab Non-ANCHOR
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
30
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Administrative Problems
|
1
|
0
|
|
Overall Study
Death
|
6
|
0
|
Baseline Characteristics
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Ranibizumab Non-ANCHOR
n=513 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Total
n=531 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 50 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
50 to < 65 years
|
49 participants
n=5 Participants
|
0 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Age, Customized
65 to < 75 years
|
173 participants
n=5 Participants
|
5 participants
n=7 Participants
|
178 participants
n=5 Participants
|
|
Age, Customized
75 to < 85 years
|
230 participants
n=5 Participants
|
12 participants
n=7 Participants
|
242 participants
n=5 Participants
|
|
Age, Customized
≥ 85 years
|
60 participants
n=5 Participants
|
1 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
294 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study (12 month treatment period)Population: For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=513 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye
|
48.5 Percentage of Participants
|
38.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study (12 month treatment period)Population: For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Grade 3 targeted AEs included: * 4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days * ≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection * sustained (\>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a \>20 mm Hg change in IOP persisting longer than 14 days * new retinal tear or detachment involving the macula * new vitreous hemorrhage \>2+ severity not resolving within 14 days * new or increase of previous retinal hemorrhage \>1 disc area in size and involving the fovea
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=513 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye
|
2.9 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters. BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=509 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=15 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
Baseline
|
56.2 Letters on the ETDRS-like testing charts
Standard Deviation 12.11
|
47.2 Letters on the ETDRS-like testing charts
Standard Deviation 22.10
|
|
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3
Change to Month 3
|
5.8 Letters on the ETDRS-like testing charts
Standard Deviation 11.12
|
1.9 Letters on the ETDRS-like testing charts
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters. BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=509 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=17 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
Baseline
|
56.2 Letters on the ETDRS-like testing charts
Standard Deviation 12.11
|
47.2 Letters on the ETDRS-like testing charts
Standard Deviation 22.10
|
|
Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12
Change to Month 12
|
3.6 Letters on the ETDRS-like testing charts
Standard Deviation 13.89
|
1.6 Letters on the ETDRS-like testing charts
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=507 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=15 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
Baseline
|
339.6 Micrometers
Standard Deviation 109.38
|
214.1 Micrometers
Standard Deviation 64.92
|
|
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3
Change to Month 3
|
-101.1 Micrometers
Standard Deviation 115.69
|
36.3 Micrometers
Standard Deviation 72.96
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF.
Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=507 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=17 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
Baseline
|
339.6 Micrometers
Standard Deviation 109.38
|
214.1 Micrometers
Standard Deviation 64.92
|
|
Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12
Change to Month 12
|
-91.5 Micrometers
Standard Deviation 115.47
|
39.3 Micrometers
Standard Deviation 84.61
|
SECONDARY outcome
Timeframe: Month 2 to Month 11Population: Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis.
Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment. Criteria for re-treatment: * a \>5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3) * a \>100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=500 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Time to the First Retreatment After Month 2
|
2 Months
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0) to Month 11Population: For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients.
Total number of treatments administered during the entire treatment period (Month 0 to 11).
Outcome measures
| Measure |
Ranibizumab Non-ANCHOR
n=513 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 Participants
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Total Number of Treatments
|
5.6 Treatments
Standard Deviation 2.37
|
1.1 Treatments
Standard Deviation 2.29
|
Adverse Events
Ranibizumab Non-ANCHOR
Serious events: 80 serious events
Other events: 199 other events
Deaths: 0 deaths
Ranibizumab ANCHOR
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab Non-ANCHOR
n=513 participants at risk
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 participants at risk
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/513
|
5.6%
1/18
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/513
|
0.00%
0/18
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/513
|
5.6%
1/18
|
|
Cardiac disorders
Angina pectoris
|
0.58%
3/513
|
0.00%
0/18
|
|
Cardiac disorders
Arrhythmia
|
0.58%
3/513
|
0.00%
0/18
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
2/513
|
5.6%
1/18
|
|
Cardiac disorders
Cardiac failure
|
1.2%
6/513
|
0.00%
0/18
|
|
Cardiac disorders
Cardiogenic shock
|
0.19%
1/513
|
0.00%
0/18
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/513
|
0.00%
0/18
|
|
Cardiac disorders
Intracardiac thrombus
|
0.19%
1/513
|
0.00%
0/18
|
|
Cardiac disorders
Myocardial infarction
|
0.97%
5/513
|
0.00%
0/18
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
1/513
|
0.00%
0/18
|
|
Cardiac disorders
Silent myocardial infarction
|
0.19%
1/513
|
0.00%
0/18
|
|
Ear and labyrinth disorders
Vertigo
|
0.19%
1/513
|
0.00%
0/18
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.19%
1/513
|
0.00%
0/18
|
|
Eye disorders
Cataract (Fellow eye)
|
0.58%
3/513
|
0.00%
0/18
|
|
Eye disorders
Cataract (Study eye)
|
0.19%
1/513
|
0.00%
0/18
|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
0.19%
1/513
|
0.00%
0/18
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.39%
2/513
|
0.00%
0/18
|
|
Eye disorders
Retinal pigment epithelial tear (Study eye)
|
0.19%
1/513
|
0.00%
0/18
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
0.19%
1/513
|
0.00%
0/18
|
|
Eye disorders
Vitreous haemorrhage (Study eye)
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Haematemesis
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.19%
1/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.39%
2/513
|
0.00%
0/18
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/513
|
0.00%
0/18
|
|
General disorders
Asthenia
|
0.39%
2/513
|
0.00%
0/18
|
|
General disorders
Chest pain
|
0.19%
1/513
|
0.00%
0/18
|
|
General disorders
Death
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Bronchitis
|
0.39%
2/513
|
0.00%
0/18
|
|
Infections and infestations
Bronchopneumonia
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Clostridium difficile colitis
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Gangrene
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Infected skin ulcer
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Pneumonia
|
0.39%
2/513
|
0.00%
0/18
|
|
Infections and infestations
Respiratory tract infection
|
0.19%
1/513
|
0.00%
0/18
|
|
Infections and infestations
Sepsis
|
0.39%
2/513
|
0.00%
0/18
|
|
Infections and infestations
Urinary tract infection
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/513
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/513
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/513
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.19%
1/513
|
0.00%
0/18
|
|
Investigations
Blood urine present
|
0.19%
1/513
|
0.00%
0/18
|
|
Investigations
Cardioactive drug level increased
|
0.19%
1/513
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
1/513
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.19%
1/513
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
4/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.19%
1/513
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.39%
2/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.58%
3/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.58%
3/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/513
|
5.6%
1/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.39%
2/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.39%
2/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.19%
1/513
|
0.00%
0/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Cerebral infarction
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/513
|
5.6%
1/18
|
|
Nervous system disorders
Diabetic coma
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/513
|
5.6%
1/18
|
|
Nervous system disorders
Presyncope
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Sciatica
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Syncope
|
0.19%
1/513
|
0.00%
0/18
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
2/513
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/513
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal failure acute
|
0.19%
1/513
|
0.00%
0/18
|
|
Renal and urinary disorders
Renal failure chronic
|
0.19%
1/513
|
0.00%
0/18
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/513
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.19%
1/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
2/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.19%
1/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
2/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.19%
1/513
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/513
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Arteriosclerosis
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Circulatory collapse
|
0.39%
2/513
|
0.00%
0/18
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Hypertension
|
0.39%
2/513
|
0.00%
0/18
|
|
Vascular disorders
Hypotension
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Peripheral embolism
|
0.19%
1/513
|
0.00%
0/18
|
|
Vascular disorders
Poor peripheral circulation
|
0.19%
1/513
|
0.00%
0/18
|
Other adverse events
| Measure |
Ranibizumab Non-ANCHOR
n=513 participants at risk
Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
Ranibizumab ANCHOR
n=18 participants at risk
Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
|
|---|---|---|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
3.1%
16/513
|
11.1%
2/18
|
|
Eye disorders
Choroidal neovascularisation (Study eye)
|
1.6%
8/513
|
11.1%
2/18
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
5.5%
28/513
|
0.00%
0/18
|
|
Eye disorders
Retinal haemorrhage (Fellow eye)
|
2.3%
12/513
|
11.1%
2/18
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
6.8%
35/513
|
27.8%
5/18
|
|
Eye disorders
Retinal oedema (Study eye)
|
1.6%
8/513
|
11.1%
2/18
|
|
Eye disorders
Visual acuity reduced (Fellow eye)
|
4.5%
23/513
|
5.6%
1/18
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
18.3%
94/513
|
5.6%
1/18
|
|
Investigations
Intraocular pressure increased (Study eye)
|
7.0%
36/513
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
2.5%
13/513
|
5.6%
1/18
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER