Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (NCT NCT00275821)
NCT ID: NCT00275821
Last Updated: 2011-03-16
Results Overview
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
353 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2011-03-16
Participant Flow
Participant milestones
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
118
|
115
|
|
Overall Study
COMPLETED
|
106
|
95
|
103
|
|
Overall Study
NOT COMPLETED
|
14
|
23
|
12
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
12
|
5
|
|
Overall Study
Administrative problems
|
3
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
5
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=120 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=118 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=115 Participants
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
50 - < 65
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Age, Customized
65 - < 75
|
37 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Age, Customized
75 - < 85
|
61 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Age, Customized
≥ 85
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Per-Protocol (PP) population includes a subset of patients from the Intent to Treat (ITT) population who completed Month 12/Visit 15, had an assessment of Best Corrected Visual Acuity in the study eye at Month 12/Visit 15 and did not have any major study protocol deviations.
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA 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.
Outcome measures
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=104 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=88 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=101 Participants
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
|
4.9 letters
Standard Deviation 13.13
|
3.8 letters
Standard Deviation 13.33
|
8.3 letters
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The intent to treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.
Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Outcome measures
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=113 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=105 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=108 Participants
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12
|
-0.21 mm^2
Standard Deviation 5.616
|
-1.51 mm^2
Standard Deviation 4.802
|
-1.28 mm^2
Standard Deviation 4.367
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.
Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.
Outcome measures
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=100 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=100 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=95 Participants
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12
|
-96.0 micrometers
Standard Deviation 96.82
|
-105.6 micrometers
Standard Deviation 128.98
|
-105.3 micrometers
Standard Deviation 128.55
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent to Treat (ITT) population, with use of Last Observation Carried Forward (LOCF), consisted of all patients randomized into the study. Patients were analyzed according to the treatment group to which they were randomized. Only patients with available data at baseline and Month 12 were included in the analysis.
Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.
Outcome measures
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=100 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=100 Participants
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=95 Participants
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12
|
-93.3 Micrometers
Standard Deviation 100.88
|
-97.5 Micrometers
Standard Deviation 117.52
|
-97.9 Micrometers
Standard Deviation 112.47
|
Adverse Events
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
Serious events: 15 serious events
Other events: 66 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
Serious events: 23 serious events
Other events: 71 other events
Deaths: 0 deaths
Ranibizumab 0.3 mg Monthly
Serious events: 20 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=120 participants at risk
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=118 participants at risk
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=115 participants at risk
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/120
|
1.7%
2/118
|
1.7%
2/115
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/120
|
1.7%
2/118
|
0.00%
0/115
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Cardiac disorders
Cardiac failure
|
2.5%
3/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Cardiac disorders
Palpitations
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Ear and labyrinth disorders
Vertigo
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Eye disorders
Blindness transient (Study eye)
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Eye disorders
Retinal artery spasm (Study eye)
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Eye disorders
Retinal detachment (Study eye)
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Eye disorders
Retinal pigment epithelial tear (Study eye)
|
0.00%
0/120
|
1.7%
2/118
|
0.00%
0/115
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.83%
1/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
General disorders
Pyrexia
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Infections and infestations
Appendicitis
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Infections and infestations
Device related infection
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Infections and infestations
Influenza
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Infections and infestations
Lung infection
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Infections and infestations
Perianal abscess
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120
|
0.00%
0/118
|
1.7%
2/115
|
|
Infections and infestations
Sepsis
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Injury, poisoning and procedural complications
Cataract traumatic (Study eye)
|
0.83%
1/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.83%
1/120
|
0.85%
1/118
|
0.87%
1/115
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma (Study eye)
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Nervous system disorders
Dementia
|
0.00%
0/120
|
0.85%
1/118
|
0.87%
1/115
|
|
Nervous system disorders
Headache
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Nervous system disorders
Syncope
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/120
|
0.85%
1/118
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.83%
1/120
|
0.00%
0/118
|
0.00%
0/115
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/120
|
0.00%
0/118
|
0.87%
1/115
|
Other adverse events
| Measure |
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly
n=120 participants at risk
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly
n=118 participants at risk
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
Ranibizumab 0.3 mg Monthly
n=115 participants at risk
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
|
|---|---|---|---|
|
Eye disorders
Blepharitis (Study eye)
|
2.5%
3/120
|
5.1%
6/118
|
2.6%
3/115
|
|
Eye disorders
Choroidal neovascularisation (Fellow eye)
|
5.8%
7/120
|
5.1%
6/118
|
2.6%
3/115
|
|
Eye disorders
Conjunctival haemorrhage (Study eye)
|
19.2%
23/120
|
16.1%
19/118
|
10.4%
12/115
|
|
Eye disorders
Eye pain (Study eye)
|
18.3%
22/120
|
11.9%
14/118
|
20.9%
24/115
|
|
Eye disorders
Eye pruritus (Study eye)
|
0.83%
1/120
|
2.5%
3/118
|
5.2%
6/115
|
|
Eye disorders
Lacrimation increased (Study eye)
|
3.3%
4/120
|
0.85%
1/118
|
5.2%
6/115
|
|
Eye disorders
Ocular hyperaemia (Study eye)
|
6.7%
8/120
|
8.5%
10/118
|
6.1%
7/115
|
|
Eye disorders
Retinal haemorrhage (Study eye)
|
3.3%
4/120
|
6.8%
8/118
|
1.7%
2/115
|
|
Eye disorders
Visual acuity reduced (Study eye)
|
12.5%
15/120
|
16.1%
19/118
|
7.8%
9/115
|
|
Eye disorders
Vitreous floaters (Study eye)
|
5.0%
6/120
|
5.1%
6/118
|
7.0%
8/115
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
11/120
|
3.4%
4/118
|
7.0%
8/115
|
|
Investigations
Intraocular pressure increased (Study eye)
|
5.0%
6/120
|
5.9%
7/118
|
14.8%
17/115
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.83%
1/120
|
2.5%
3/118
|
6.1%
7/115
|
|
Nervous system disorders
Headache
|
1.7%
2/120
|
5.1%
6/118
|
4.3%
5/115
|
|
Vascular disorders
Hypertension
|
8.3%
10/120
|
5.1%
6/118
|
7.0%
8/115
|
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