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Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

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ClinicalTrials.gov Identifier: NCT01580020
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : May 17, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Retinal Vein Occlusion
Interventions Biological: RFB002
Drug: Dexamethasone
Enrollment 175
Recruitment Details A total of 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled
Pre-assignment Details The Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. LOCF=last observation carried forward
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required. Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Period Title: Overall Study
Started 52 40 61 22
Completed 51 33 57 20
Not Completed 1 7 4 2
Reason Not Completed
Lack of Efficacy             0             5             0             1
Withdrawal by Subject             0             1             1             0
Adverse Event             1             1             1             1
Administrative Problems             0             0             1             0
Lost to Follow-up             0             0             1             0
Arm/Group Title Ranibizumab Dexamethasone Total
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required. Total of all reporting groups
Overall Number of Baseline Participants 113 62 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 62 participants 175 participants
65.6  (9.9) 63.3  (10.3) 64.8  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 62 participants 175 participants
Female
64
  56.6%
26
  41.9%
90
  51.4%
Male
49
  43.4%
36
  58.1%
85
  48.6%
1.Primary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description The number of participants who experienced Adverse events, serious AE and death
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 61 22
Measure Type: Number
Unit of Measure: Participants
Adverse event 35 28 45 16
Serious adverse event 2 3 6 1
Death 0 0 0 0
2.Secondary Outcome
Title Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group
Hide Description Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement
Time Frame Baseline, 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 60 22
Mean (Standard Deviation)
Unit of Measure: Letters read correctly
Baseline 56.8  (10.0) 58.3  (10.8) 53.8  (15.7) 53.2  (16.1)
Month 6 77.9  (10.6) 69.2  (11.9) 72.6  (13.5) 64.1  (24.0)
Month 12 79.0  (10.1) 70.6  (13.9) 72.6  (15.8) 66.6  (22.3)
3.Secondary Outcome
Title Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline
Hide Description BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 60 22
Measure Type: Number
Unit of Measure: Percentage of participants
Gain≥15 letters 80.8 50.0 58.3 45.5
Gain ≥10 letters 88.5 65.0 75.0 68.2
Gain ≥5 letters 100.0 80.0 86.7 77.3
Loss of ≥15 letters 0.0 7.5 0.0 4.5
Loss of ≥10 letters 0.0 10.0 0.0 4.5
Loss of ≥5 letters 0.0 10.0 3.3 4.5
4.Secondary Outcome
Title Change in Central Subfield Thickness (CSRT) From Baseline to Month 12
Hide Description High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.
Time Frame Baseline , Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 59 22
Mean (Standard Deviation)
Unit of Measure: um
-288.1  (180.6) -211.5  (199.3) -374.6  (239.8) -360.3  (260.2)
5.Secondary Outcome
Title Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12
Hide Description FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 51 39 58 21
Mean (Standard Deviation)
Unit of Measure: um
-341.8  (226.2) -252.6  (197.9) -439.4  (279.8) -432.3  (245.8)
6.Secondary Outcome
Title Change in Mean Visual Function Questionnaire (VFQ-25)
Hide Description The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.
Time Frame Baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 60 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Overall Composite 8.1  (10.6) 5.5  (11.3) 9.1  (15.5) 10.0  (15.9)
General Health -1.4  (15.2) 6.3  (18.6) 1.7  (18.9) 5.7  (20.3)
General Vision 15.0  (16.7) 9.5  (16.3) 20.0  (17.7) 13.6  (23.4)
Ocular Pain 5.3  (15.7) 5.3  (13.8) 4.2  (20.8) 3.4  (15.0)
Near Activities 13.3  (18.9) 10.8  (20.6) 12.3  (20.5) 12.3  (23.2)
Distance Activities 8.9  (17.5) 5.6  (15.3) 7.8  (18.3) 8.3  (23.4)
Social Functioning 3.4  (16.8) 2.2  (12.0) 3.3  (16.7) 2.8  (21.1)
Mental Health 10.2  (14.9) 2.9  (20.4) 10.7  (21.7) 15.1  (18.3)
Role Difficulties 4.8  (26.8) 10.6  (20.5) 14.6  (29.9) 24.4  (27.8)
Dependency 3.2  (9.2) 0.4  (16.6) 5.1  (16.7) 4.4  (12.8)
Driving (BRVO n=44,31) (CRVO n=42,16) 11.7  (23.9) 4.8  (21.3) 14.2  (24.6) 17.7  (25.1)
Color Vision(BRVO n=52,39) 0.5  (10.5) 1.9  (10.6) 0.4  (17.5) -1.1  (14.4)
Peripheral Vision(BRVO n=51,40) 10.3  (24.1) 6.9  (23.3) 11.7  (25.0) 14.8  (22.7)
7.Secondary Outcome
Title Change in SF-36 Summary Scores
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.
Time Frame Baseline, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 60 22
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Physical Component(BRVO n=50,39) (CRVO n=58,20) 1.6  (5.0) 0.2  (7.0) -1.1  (8.2) 1.3  (7.2)
Mental Component (BRVO n=50,39) (CRVO n=58,20) 3.3  (9.7) 2.1  (13.2) 2.1  (9.3) 2.4  (12.4)
8.Secondary Outcome
Title Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores
Hide Description The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled "Best imaginable health state" (100) and "worst imaginable health state" (0).
Time Frame Baseline, month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 58 21
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.3  (15.2) 2.6  (16.9) 1.5  (16.4) 0.2  (20.4)
9.Secondary Outcome
Title Time to the First Retreatment of Both Treatment Arms
Hide Description Time to the first retreatment
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
Overall Number of Participants Analyzed 52 40 61 22
Median (95% Confidence Interval)
Unit of Measure: Days
37
(3 to 56)
NA [1] 
(328 to NA)
62
(5 to 67)
NA [1] 
(309 to NA)
[1]
Not calculable because <50% of patients received re-treatment
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.
 
Arm/Group Title Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
All-Cause Mortality
Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/52 (3.85%)   3/40 (7.50%)   6/61 (9.84%)   1/22 (4.55%) 
Eye disorders         
GLAUCOMA (Fellow eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
GLAUCOMA (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
IRIS NEOVASCULARISATION (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
MACULAR OEDEMA (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
OCULAR ISCHAEMIC SYNDROME (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
RETINAL DETACHMENT (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
VISUAL ACUITY REDUCED (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
VITREOUS HAEMORRHAGE (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders         
INTERVERTEBRAL DISC PROTRUSION  1  1/52 (1.92%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
ROTATOR CUFF SYNDROME  1  0/52 (0.00%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
SQUAMOUS CELL CARCINOMA OF SKIN  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
Nervous system disorders         
LUMBAR RADICULOPATHY  1  0/52 (0.00%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
Psychiatric disorders         
SUBSTANCE ABUSE  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
PULMONARY EMBOLISM  1  1/52 (1.92%)  0/40 (0.00%)  0/61 (0.00%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders         
PSORIASIS  1  0/52 (0.00%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Ranibizumab (BRVO) Dexamethasone (BRVO) Ranibizumab (CRVO) Dexamethasone (CRVO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/52 (67.31%)   28/40 (70.00%)   45/61 (73.77%)   16/22 (72.73%) 
Congenital, familial and genetic disorders         
FACTOR V LEIDEN MUTATION  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
Eye disorders         
CATARACT (Study eye)  1  0/52 (0.00%)  3/40 (7.50%)  2/61 (3.28%)  1/22 (4.55%) 
CONJUNCTIVAL HAEMORRHAGE (Study eye)  1  2/52 (3.85%)  7/40 (17.50%)  3/61 (4.92%)  3/22 (13.64%) 
CONJUNCTIVAL HYPERAEMIA (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
CONJUNCTIVAL IRRITATION (Study eye)  1  1/52 (1.92%)  2/40 (5.00%)  0/61 (0.00%)  0/22 (0.00%) 
CONJUNCTIVITIS ALLERGIC (Study eye)  1  0/52 (0.00%)  1/40 (2.50%)  0/61 (0.00%)  1/22 (4.55%) 
DRY EYE (Fellow eye)  1  2/52 (3.85%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
DRY EYE (Study eye)  1  3/52 (5.77%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
EYE PAIN (Study eye)  1  4/52 (7.69%)  0/40 (0.00%)  7/61 (11.48%)  4/22 (18.18%) 
FOREIGN BODY SENSATION IN EYES (Study eye)  1  0/52 (0.00%)  1/40 (2.50%)  4/61 (6.56%)  0/22 (0.00%) 
GLAUCOMA (Study eye)  1  0/52 (0.00%)  1/40 (2.50%)  1/61 (1.64%)  1/22 (4.55%) 
LACRIMATION INCREASED (Study eye)  1  6/52 (11.54%)  2/40 (5.00%)  2/61 (3.28%)  2/22 (9.09%) 
MACULAR FIBROSIS (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  2/61 (3.28%)  0/22 (0.00%) 
MACULAR OEDEMA (Study eye)  1  9/52 (17.31%)  3/40 (7.50%)  14/61 (22.95%)  3/22 (13.64%) 
OCULAR DISCOMFORT (Study eye)  1  2/52 (3.85%)  4/40 (10.00%)  1/61 (1.64%)  0/22 (0.00%) 
OCULAR HYPERAEMIA (Study eye)  1  7/52 (13.46%)  3/40 (7.50%)  4/61 (6.56%)  3/22 (13.64%) 
PHOTOPSIA (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  2/61 (3.28%)  0/22 (0.00%) 
RETINAL EXUDATES (Study eye)  1  2/52 (3.85%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
RETINAL ISCHAEMIA (Study eye)  1  5/52 (9.62%)  4/40 (10.00%)  2/61 (3.28%)  0/22 (0.00%) 
RETINAL OEDEMA (Study eye)  1  2/52 (3.85%)  1/40 (2.50%)  0/61 (0.00%)  0/22 (0.00%) 
VISION BLURRED (Study eye)  1  1/52 (1.92%)  0/40 (0.00%)  4/61 (6.56%)  1/22 (4.55%) 
VISUAL ACUITY REDUCED (Study eye)  1  4/52 (7.69%)  4/40 (10.00%)  8/61 (13.11%)  1/22 (4.55%) 
VISUAL IMPAIRMENT (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
VITREOUS DETACHMENT (Fellow eye)  1  0/52 (0.00%)  2/40 (5.00%)  1/61 (1.64%)  0/22 (0.00%) 
VITREOUS DETACHMENT (Study eye)  1  2/52 (3.85%)  2/40 (5.00%)  1/61 (1.64%)  0/22 (0.00%) 
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  1/52 (1.92%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
GASTRITIS  1  0/52 (0.00%)  0/40 (0.00%)  2/61 (3.28%)  1/22 (4.55%) 
General disorders         
CHEST DISCOMFORT  1  1/52 (1.92%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
PYREXIA  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
Infections and infestations         
BRONCHITIS  1  1/52 (1.92%)  2/40 (5.00%)  2/61 (3.28%)  0/22 (0.00%) 
CONJUNCTIVITIS (Study eye)  1  0/52 (0.00%)  1/40 (2.50%)  2/61 (3.28%)  0/22 (0.00%) 
CYSTITIS  1  2/52 (3.85%)  0/40 (0.00%)  0/61 (0.00%)  0/22 (0.00%) 
GASTROENTERITIS  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
GASTROINTESTINAL INFECTION  1  0/52 (0.00%)  0/40 (0.00%)  2/61 (3.28%)  0/22 (0.00%) 
HERPES ZOSTER  1  1/52 (1.92%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
INFLUENZA  1  1/52 (1.92%)  1/40 (2.50%)  0/61 (0.00%)  1/22 (4.55%) 
NASOPHARYNGITIS  1  9/52 (17.31%)  3/40 (7.50%)  12/61 (19.67%)  3/22 (13.64%) 
PERIODONTITIS  1  1/52 (1.92%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
RESPIRATORY TRACT INFECTION  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
RHINITIS  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
SINUSITIS  1  2/52 (3.85%)  0/40 (0.00%)  1/61 (1.64%)  0/22 (0.00%) 
URINARY TRACT INFECTION  1  2/52 (3.85%)  0/40 (0.00%)  0/61 (0.00%)  0/22 (0.00%) 
Injury, poisoning and procedural complications         
FALL  1  1/52 (1.92%)  2/40 (5.00%)  0/61 (0.00%)  0/22 (0.00%) 
MUSCLE STRAIN  1  1/52 (1.92%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
POST PROCEDURAL SWELLING (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
INTRAOCULAR PRESSURE DECREASED (Study eye)  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
INTRAOCULAR PRESSURE INCREASED (Study eye)  1  3/52 (5.77%)  10/40 (25.00%)  3/61 (4.92%)  4/22 (18.18%) 
Metabolism and nutrition disorders         
VITAMIN D DEFICIENCY  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders         
BACK PAIN  1  3/52 (5.77%)  2/40 (5.00%)  6/61 (9.84%)  1/22 (4.55%) 
OSTEOARTHRITIS  1  2/52 (3.85%)  0/40 (0.00%)  0/61 (0.00%)  0/22 (0.00%) 
SJOGREN'S SYNDROME  1  0/52 (0.00%)  0/40 (0.00%)  2/61 (3.28%)  0/22 (0.00%) 
Nervous system disorders         
HEADACHE  1  0/52 (0.00%)  2/40 (5.00%)  1/61 (1.64%)  1/22 (4.55%) 
SCIATICA  1  1/52 (1.92%)  0/40 (0.00%)  2/61 (3.28%)  0/22 (0.00%) 
TRIGEMINAL NEURALGIA  1  0/52 (0.00%)  0/40 (0.00%)  0/61 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  3/52 (5.77%)  1/40 (2.50%)  1/61 (1.64%)  0/22 (0.00%) 
OROPHARYNGEAL PAIN  1  2/52 (3.85%)  1/40 (2.50%)  1/61 (1.64%)  0/22 (0.00%) 
Vascular disorders         
HYPERTENSION  1  0/52 (0.00%)  0/40 (0.00%)  1/61 (1.64%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 or disclosure of trial results in their entirety
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01580020     History of Changes
Other Study ID Numbers: CRFB002EDE20
2011-005045-13 ( EudraCT Number )
First Submitted: April 16, 2012
First Posted: April 18, 2012
Results First Submitted: September 28, 2015
Results First Posted: May 17, 2016
Last Update Posted: May 17, 2016