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Camellia: Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01976312
Collaborator
(none)
252
Enrollment
34
Locations
2
Arms
28
Actual Duration (Months)
7.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Condition or Disease Intervention/Treatment Phase
  • Other: Sham injection
  • Drug: Ranibizumab 0.5 mg
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
252 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central Retinal Vein Occlusion (CRVO) [Camellia]
Actual Study Start Date :
Nov 12, 2013
Actual Primary Completion Date :
Mar 14, 2016
Actual Study Completion Date :
Mar 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ranibizumab 0.5 mg

PRN intravitreal injection

Drug: Ranibizumab 0.5 mg
Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
Other Names:
  • Lucentis

    		•
    Sham Comparator: Sham injection

    As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

    Other: Sham injection
    Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

    Outcome Measures

    Primary Outcome Measures

    1. Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 [Baseline, 3 Months]

      Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.

    Secondary Outcome Measures

    1. Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 [Baseline, 12 months]

      Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

    2. Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time [Month 1 to 12 months]

      Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline

    3. Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time [Month 1 to month 12]

      OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.

    4. Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time [Month 1 to month 12]

      Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.

    5. Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time [Month 1 to 12 months]

      Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

    6. The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline [Month 3,6 and 12]

      The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria for study and fellow eye:

    • Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.

    Exclusion Criteria:

    • Pregnant or nursing women or women of child bearing potential unless using an effective contraception

    • Stroke or myocard infarction within 3 months prior to study

    • History of malignancy within the past 5 years

    • Uncontrolled hypertension

    • Active infection or inflammation in any eye

    • use of corticosteroids for at least 30 days in the last 6 months

    • treatment with anti-angiogenic drugs in any eye within last 3 months

    • Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months respectively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Beijing Beijing China 100191
    2 Novartis Investigative Site Beijing Beijing China 100730
    3 Novartis Investigative Site Chongqing Chongqing China 400042
    4 Novartis Investigative Site Guangzhou Guangdong China 510060
    5 Novartis Investigative Site Shantou Guangdong China 515041
    6 Novartis Investigative Site Harbin Heilongjiang China 150001
    7 Novartis Investigative Site Wuhan Hubei China 430070
    8 Novartis Investigative Site Changsha Hunan China 410011
    9 Novartis Investigative Site Nanjing Jiangsu China 210006
    10 Novartis Investigative Site Nanjing Jiangsu China 210029
    11 Novartis Investigative Site Nantong Jiangsu China 226000
    12 Novartis Investigative Site Nanchang Jiangxi China 330006
    13 Novartis Investigative Site Qingdao Shandong China 266011
    14 Novartis Investigative Site Chengdu Sichuan China 610041
    15 Novartis Investigative Site Tianjin Tianjin China 300020
    16 Novartis Investigative Site Tianjin Tianjin China 300070
    17 Novartis Investigative Site Wenzhou Zhejiang China 325027
    18 Novartis Investigative Site Beijing China 100034
    19 Novartis Investigative Site Beijing China 100176
    20 Novartis Investigative Site Beijing China 100730
    21 Novartis Investigative Site Chongqing China 400038
    22 Novartis Investigative Site Shanghai China 200080
    23 Novartis Investigative Site Shanghai China 200092
    24 Novartis Investigative Site Hongkong Hong Kong
    25 Novartis Investigative Site Ahmedabad Gujarat India 380 016
    26 Novartis Investigative Site Bhubaneswar Orissa India 751 024
    27 Novartis Investigative Site Bandung Jawa Barat Indonesia 40117
    28 Novartis Investigative Site Jakarta Indonesia 10430
    29 Novartis Investigative Site Manila Metro Manila Philippines 1000
    30 Novartis Investigative Site San Juan City Philippines 1500
    31 Novartis Investigative Site Lin-Kou Taiwan 33305
    32 Novartis Investigative Site Taipei Taiwan
    33 Novartis Investigative Site Hanoi Vietnam 10000
    34 Novartis Investigative Site Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01976312
    Other Study ID Numbers:
    • CRFB002E2302
    First Posted:
    Nov 5, 2013
    Last Update Posted:
    May 30, 2017
    Last Verified:
    Apr 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab
    Additional relevant MeSH terms:
    Retinal Vein Occlusion
    Ranibizumab

    Study Results

    Participant Flow

    Recruitment Details A total of 253 patients were randomized to this study, 191 patients to the ranibizumab group and 62 patients to the sham group. One patient randomized to the ranibizumab group was excluded from all analyses as informed consent was obtained after first study procedures were performed. Therefore, this patient not included in randomized set.
    Pre-assignment Detail This study consisted of the 3 periods (Screening period: Day -14 to Day -1; treatment period: Day 1 to Month 11; post-treatment period: Month 11 to Month 12). At Baseline (Visit 2, Day 1), eligible patients were randomized in a 3:1 ratio to one of the treatment arms
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Period Title: Overall Study
    STARTED 190 62
    Completed 3 Months 186 60
    Discontinued Study Prior to 3 Months 4 2
    COMPLETED 173 53
    NOT COMPLETED 17 9

    Baseline Characteristics

    Arm/Group Title Ranibizumab 0.5 mg Sham Injection Total
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections Total of all reporting groups
    Overall Participants 190 62 252
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    54.1
    (12.64)
    54.1
    (13.29)
    54.1
    (12.77)
    Sex: Female, Male (Count of Participants)
    Female
    88
    46.3%
    29
    46.8%
    117
    46.4%
    Male
    102
    53.7%
    33
    53.2%
    135
    53.6%

    Outcome Measures

    1. Primary Outcome
    Title Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
    Description Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.
    Time Frame Baseline, 3 Months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Mean (Standard Deviation) [Letters]
    11.3
    (10.77)
    -2.7
    (13.92)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Ranibizumab 0.5 mg, Sham Injection
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    2. Secondary Outcome
    Title Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
    Description Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
    Time Frame Baseline, 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Mean (Standard Deviation) [Letters]
    12.4
    (11.43)
    3.2
    (14.62)
    3. Secondary Outcome
    Title Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time
    Description Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
    Time Frame Month 1 to 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Month 1
    9.6
    (10.2)
    -0.9
    (12.17)
    Month 2
    11.6
    (12.39)
    -3.4
    (16.04)
    Month 3
    12.6
    (12.01)
    -3.8
    (17.02)
    Month 4
    10.7
    (12.56)
    2.8
    (15.26)
    Month 5
    11.7
    (12.62)
    3.9
    (15.26)
    Month 6
    12.3
    (13.10)
    3.8
    (17.20)
    Month 7
    12.9
    (13.36)
    5.0
    (16.71)
    Month 8
    12.4
    (14.01)
    6.0
    (16.01)
    Month 9
    13.1
    (15.10)
    5.6
    (16.95)
    Month 10
    13.5
    (14.13)
    5.9
    (16.77)
    Month 11
    14.2
    (13.15)
    6.8
    (16.30)
    Month 12
    14.5
    (14.25)
    6.5
    (17.10)
    4. Secondary Outcome
    Title Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
    Description OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.
    Time Frame Month 1 to month 12

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Month 1
    -393.7
    (275.13)
    -13.3
    (207.55)
    Month 2
    -412.6
    (297.50)
    -7.9
    (196.65)
    Month 3
    -433.3
    (290.84)
    -84.4
    (274.98)
    Month 4
    -367.8
    (305.26)
    -364.8
    (250.48)
    Month 5
    -407.0
    (309.58)
    -369.6
    (273.92)
    Month 6
    -426.6
    (294.63)
    -372.3
    (301.24)
    Month 7
    -421.5
    (316.14)
    -392.7
    (288.74)
    Month 8
    -398.9
    (299.67)
    -405.2
    (289.49)
    Month 9
    -422.1
    (311.57)
    -393.5
    (323.50)
    Month 10
    -431.7
    (300.95)
    -395.2
    (309.67)
    Month 11
    -438.1
    (295.53)
    -417.4
    (288.08)
    Month 12
    -441.7
    (306.53)
    -416.4
    (294.08)
    5. Secondary Outcome
    Title Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
    Description Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
    Time Frame Month 1 to month 12

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Month 1 Gain of >=5 letters
    141
    74.2%
    17
    27.4%
    Month 1 Gain of >=10 letters
    94
    49.5%
    6
    9.7%
    Month 1 Gain of >=15 letters
    56
    29.5%
    2
    3.2%
    Month 1 Gain of >=30 letters
    3
    1.6%
    0
    0%
    Month 2 Gain of >=5 letters
    150
    78.9%
    18
    29%
    Month 2 Gain of >=10 letters
    119
    62.6%
    11
    17.7%
    Month 2 Gain of >=15 letters
    74
    38.9%
    3
    4.8%
    Month 2 Gain of >=30 letters
    9
    4.7%
    0
    0%
    Month 3 Gain of >=5 letters
    153
    80.5%
    19
    30.6%
    Month 3 Gain of >=10 letters
    117
    61.6%
    11
    17.7%
    Month 3 Gain of >=15 letters
    76
    40%
    4
    6.5%
    Month 3 Gain of >=30 letters
    12
    6.3%
    0
    0%
    Month 4 Gain of >=5 letters
    138
    72.6%
    31
    50%
    Month 4 Gain of >=10 letters
    107
    56.3%
    21
    33.9%
    Month 4 Gain of >=15 letters
    68
    35.8%
    11
    17.7%
    Month 4 Gain of >=30 letters
    14
    7.4%
    2
    3.2%
    Month 5 Gain of >=5 letters
    143
    75.3%
    34
    54.8%
    Month 5 Gain of >=10 letters
    116
    61.1%
    23
    37.1%
    Month 5 Gain of >=15 letters
    80
    42.1%
    13
    21%
    Month 5 Gain of >=30 letters
    13
    6.8%
    1
    1.6%
    Month 6 Gain of >=5 letters
    147
    77.4%
    39
    62.9%
    Month 6 Gain of >=10 letters
    121
    63.7%
    28
    45.2%
    Month 6 Gain of >=15 letters
    87
    45.8%
    12
    19.4%
    Month 6 Gain of >=30 letters
    14
    7.4%
    13
    21%
    Month 7 Gain of >=5 letters
    152
    80%
    37
    59.7%
    Month 7 Gain of >=10 letters
    121
    63.7%
    29
    46.8%
    Month 7 Gain of >=15 letters
    91
    47.9%
    14
    22.6%
    Month 7 Gain of >=30 letters
    14
    7.4%
    3
    4.8%
    Month 8 Gain of >=5 letters
    143
    75.3%
    39
    62.9%
    Month 8 Gain of >=10 letters
    127
    66.8%
    28
    45.2%
    Month 8 Gain of >=15 letters
    95
    50%
    19
    30.6%
    Month 8 Gain of >=30 letters
    16
    8.4%
    3
    4.8%
    Month 9 Gain of >=5 letters
    147
    77.4%
    40
    64.5%
    Month 9 Gain of >=10 letters
    126
    66.3%
    26
    41.9%
    Month 9 Gain of >=15 letters
    94
    49.5%
    17
    27.4%
    Month 9 Gain of >=30 letters
    17
    8.9%
    3
    4.8%
    Month 10 Gain of >=5 letters
    152
    80%
    39
    62.9%
    Month 10 Gain of >=10 letters
    128
    67.4%
    29
    46.8%
    Month 10 Gain of >=15 letters
    95
    50%
    16
    25.8%
    Month 10 Gain of >=30 letters
    18
    9.5%
    4
    6.5%
    Month 11 Gain of >=5 letters
    153
    80.5%
    40
    64.5%
    Month 11 Gain of >=10 letters
    134
    70.5%
    29
    46.8%
    Month 11 Gain of >=15 letters
    101
    53.2%
    19
    30.6%
    Month 11 Gain of >=30 letters
    18
    9.5%
    4
    6.5%
    Month 12 Gain of >=5 letters
    151
    79.5%
    39
    62.9%
    Month 12 Gain of >=10 letters
    131
    68.9%
    30
    48.4%
    Month 12 Gain of >=15 letters
    99
    52.1%
    21
    33.9%
    Month 12 Gain of >=30 letters
    24
    12.6%
    3
    4.8%
    6. Secondary Outcome
    Title Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time
    Description Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
    Time Frame Month 1 to 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 188 62
    Month 1, Loss of < 15 letters
    185
    97.4%
    57
    91.9%
    Month 2, Loss of < 15 letters
    182
    95.8%
    53
    85.5%
    Month 3, Loss of < 15 letters
    182
    95.8%
    51
    82.3%
    Month 4, Loss of < 15 letters
    179
    94.2%
    55
    88.7%
    Month 5, Loss of < 15 letters
    182
    95.8%
    56
    90.3%
    Month 6, Loss of < 15 letters
    180
    94.7%
    53
    85.5%
    Month 7, Loss of < 15 letters
    181
    95.3%
    55
    88.7%
    Month 8, Loss of < 15 letters
    177
    93.2%
    55
    88.7%
    Month 9, Loss of < 15 letters
    177
    93.2%
    56
    90.3%
    Month 10, Loss of < 15 letters
    180
    94.7%
    56
    90.3%
    Month 11, Loss of < 15 letters
    183
    96.3%
    56
    90.3%
    Month 12, Loss of < 15 letters
    182
    95.8%
    55
    88.7%
    7. Secondary Outcome
    Title The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
    Description The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
    Time Frame Month 3,6 and 12

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.
    Arm/Group Title Ranibizumab 0.5 mg Sham Injection
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
    Measure Participants 190 62
    Month 3
    4.4
    (12.54)
    0.1
    (13.78)
    Month 6
    6.7
    (15.02)
    2.9
    (13.33)
    Month 12
    8.2
    (13.70)
    3.2
    (15.34)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The Safety Set consisted of all patients who received at least one application of study treatment and had at least one post-Baseline safety assessment. Patients were analyzed according to the treatment received. The statement that a patient had no AEs also constituted a safety assessment.
    Arm/Group Title Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
    Arm/Group Description PRN intravitreal injection As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
    All Cause Mortality
    Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/190 (5.8%) 5/56 (8.9%) 1/5 (20%)
    Cardiac disorders
    Acute myocardial infarction 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Left ventricular dysfunction 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Eye disorders
    Angle closure glaucoma 2/190 (1.1%) 1/56 (1.8%) 0/5 (0%)
    Keratitis 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Macular fibrosis 0/190 (0%) 0/56 (0%) 1/5 (20%)
    Gastrointestinal disorders
    Gastric ulcer 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Infections and infestations
    Endophthalmitis 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Herpes zoster 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Urinary tract infection 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Injury, poisoning and procedural complications
    Wrist fracture 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Inflammatory pseudotumour 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Schwannoma 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Nervous system disorders
    Haemorrhage intracranial 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Transient ischaemic attack 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    Mediastinal cyst 1/190 (0.5%) 0/56 (0%) 0/5 (0%)
    Pulmonary arterial hypertension 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Other (Not Including Serious) Adverse Events
    Ranibizumab 0.5 mg Sham With Ranibizumab 0.5 mg Sham Without Ranibizumab 0.5 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 96/190 (50.5%) 32/56 (57.1%) 3/5 (60%)
    Cardiac disorders
    Cardiovascular insufficiency 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Eye disorders
    Asthenopia 2/190 (1.1%) 0/56 (0%) 1/5 (20%)
    Cataract 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Conjunctival haemorrhage 17/190 (8.9%) 3/56 (5.4%) 0/5 (0%)
    Conjunctival hyperaemia 3/190 (1.6%) 1/56 (1.8%) 0/5 (0%)
    Conjunctival oedema 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Cystoid macular oedema 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Dry eye 7/190 (3.7%) 1/56 (1.8%) 1/5 (20%)
    Eye discharge 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Eye irritation 4/190 (2.1%) 0/56 (0%) 0/5 (0%)
    Eye pain 4/190 (2.1%) 2/56 (3.6%) 1/5 (20%)
    Eye pruritus 2/190 (1.1%) 1/56 (1.8%) 0/5 (0%)
    Eye swelling 4/190 (2.1%) 0/56 (0%) 0/5 (0%)
    Foreign body sensation in eyes 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Glaucoma 2/190 (1.1%) 0/56 (0%) 1/5 (20%)
    Iris neovascularisation 0/190 (0%) 2/56 (3.6%) 1/5 (20%)
    Lacrimation increased 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Macular fibrosis 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Macular oedema 1/190 (0.5%) 3/56 (5.4%) 0/5 (0%)
    Ocular discomfort 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Ocular hyperaemia 9/190 (4.7%) 2/56 (3.6%) 0/5 (0%)
    Ocular hypertension 2/190 (1.1%) 4/56 (7.1%) 0/5 (0%)
    Retinal haemorrhage 1/190 (0.5%) 5/56 (8.9%) 0/5 (0%)
    Retinal ischaemia 2/190 (1.1%) 1/56 (1.8%) 0/5 (0%)
    Retinal neovascularisation 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Retinal vein occlusion 2/190 (1.1%) 2/56 (3.6%) 0/5 (0%)
    Vision blurred 9/190 (4.7%) 1/56 (1.8%) 0/5 (0%)
    Visual acuity reduced 9/190 (4.7%) 3/56 (5.4%) 1/5 (20%)
    Vitreal cells 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Vitreous detachment 1/190 (0.5%) 0/56 (0%) 1/5 (20%)
    Vitreous floaters 3/190 (1.6%) 0/56 (0%) 0/5 (0%)
    Vitreous haemorrhage 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Gastrointestinal disorders
    Abdominal distension 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Abdominal pain upper 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Constipation 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Diarrhoea 4/190 (2.1%) 1/56 (1.8%) 0/5 (0%)
    Gastritis 3/190 (1.6%) 0/56 (0%) 0/5 (0%)
    General disorders
    Malaise 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Infections and infestations
    Conjunctivitis 9/190 (4.7%) 4/56 (7.1%) 0/5 (0%)
    Dacryocystitis 0/190 (0%) 0/56 (0%) 1/5 (20%)
    Hordeolum 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Nasopharyngitis 19/190 (10%) 5/56 (8.9%) 0/5 (0%)
    Pharyngitis 5/190 (2.6%) 1/56 (1.8%) 0/5 (0%)
    Upper respiratory tract infection 13/190 (6.8%) 2/56 (3.6%) 0/5 (0%)
    Urinary tract infection 4/190 (2.1%) 0/56 (0%) 0/5 (0%)
    Injury, poisoning and procedural complications
    Fall 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Ligament sprain 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Spinal compression fracture 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Wrist fracture 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Investigations
    Activated partial thromboplastin time prolonged 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Intraocular pressure increased 10/190 (5.3%) 1/56 (1.8%) 0/5 (0%)
    Platelet count decreased 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus 3/190 (1.6%) 1/56 (1.8%) 0/5 (0%)
    Type 2 diabetes mellitus 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    Arthritis 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Back pain 2/190 (1.1%) 1/56 (1.8%) 0/5 (0%)
    Neck pain 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Osteoporosis 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Nervous system disorders
    Dizziness 1/190 (0.5%) 1/56 (1.8%) 0/5 (0%)
    Headache 2/190 (1.1%) 0/56 (0%) 0/5 (0%)
    Paraesthesia 0/190 (0%) 0/56 (0%) 1/5 (20%)
    Psychiatric disorders
    Insomnia 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 6/190 (3.2%) 3/56 (5.4%) 0/5 (0%)
    Oropharyngeal pain 2/190 (1.1%) 2/56 (3.6%) 1/5 (20%)
    Throat irritation 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 0/190 (0%) 1/56 (1.8%) 0/5 (0%)
    Vascular disorders
    Hypertension 11/190 (5.8%) 4/56 (7.1%) 0/5 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Study Director
    Organization Novartis
    Phone 862-778-8300
    Email
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01976312
    Other Study ID Numbers:
    • CRFB002E2302
    First Posted:
    Nov 5, 2013
    Last Update Posted:
    May 30, 2017
    Last Verified:
    Apr 1, 2017