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Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

Sponsor
QLT Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00492284
Collaborator
(none)
162
Enrollment
26
Locations
4
Arms
34
Duration (Months)
6.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1/4 Fluence Triple Therapy

Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

Drug: verteporfin
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
Other Names:
  • Visudyne
  • photodynamic therapy

    • Drug: ranibizumab
    0.5 mg intravitreal injection
    Other Names:
  • Lucentis

    • Drug: dexamethasone
    0.5 mg intravitreal injection
    Experimental: 1/2 Fluence Triple Therapy

    Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

    Drug: verteporfin
    Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
    Other Names:
  • Visudyne
  • photodynamic therapy

    • Drug: ranibizumab
    0.5 mg intravitreal injection
    Other Names:
  • Lucentis

    • Drug: dexamethasone
    0.5 mg intravitreal injection
    Experimental: 1/2 Fluence Double Therapy

    Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter

    Drug: verteporfin
    Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
    Other Names:
  • Visudyne
  • photodynamic therapy

    • Drug: ranibizumab
    0.5 mg intravitreal injection
    Other Names:
  • Lucentis

    		•
    Experimental: Ranibizumab

    Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter

    Drug: ranibizumab
    0.5 mg intravitreal injection
    Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Number of Retreatments (Day 0 Excluded) [Month 1 to Month 12]

      Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.

    2. Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart) [Baseline to Month 12]

      Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

    Secondary Outcome Measures

    1. Mean Number of Retreatments (Day 0 Excluded) [Month 1 to Month 24]

      Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.

    2. Mean Change From Baseline in Study Eye Best-Corrected VA Score [Baseline to Month 24]

      Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

    3. Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline [Baseline to Month 12, Baseline to Month 24]

    4. Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline [Baseline to Month 12, Baseline to Month 24]

    5. Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline [Baseline to Month 12, Baseline to Month 24]

    6. Mean Change From Baseline in Central Retinal Thickness [Baseline to Month 12, Baseline to Month 24]

    7. Mean Change From Baseline in Lesion Size [Baseline to Month 12, Baseline to Month 24]

      Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area

    • Subfoveal CNV due to AMD

    • CNV must be = or >50 % of the entire lesion

    • All lesion composition types with a lesion greatest linear dimension (GLD) < 5400 microns (approximately = or <9 disc areas [DA])

    • Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive

    Exclusion Criteria:

    • Subfoveal geographic atrophy or subfoveal fibrosis of the study eye

    • Intraocular surgery within 3 months of enrollment

    • Inability to attend the protocol-required visits

    • Known allergies or hypersensitivity to any of the study treatments.

    • Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk

    • Uncontrolled glaucoma, defined as (1)subject is on >1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration

    • If subject has had a stroke within the last year

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mobile Alabama United States
    2 Phoenix Arizona United States
    3 Retina Centers, PC Tucson Arizona United States
    4 Beverly Hills California United States
    5 Campbell California United States
    6 Los Angeles California United States
    7 Poway California United States
    8 Sacramento California United States
    9 Torrance California United States
    10 Fort Myers Florida United States
    11 Indianapolis Indiana United States
    12 Davenport Iowa United States
    13 Missoula Montana United States
    14 Omaha Nebraska United States
    15 Portsmouth New Hampshire United States
    16 Portland Oregon United States
    17 Philadelphia Pennsylvania United States
    18 West Mifflin Pennsylvania United States
    19 Arlington Texas United States
    20 Temple Texas United States
    21 Seattle Washington United States
    22 Calgary Alberta Canada
    23 Vancouver British Columbia Canada
    24 Halifax Nova Scotia Canada
    25 London Ontario Canada
    26 Toronto Ontario Canada

    Sponsors and Collaborators

    • QLT Inc.

    Investigators

    • Principal Investigator: Henry Hudson, MD, Retina Centers, PC
    • Principal Investigator: Allen Ho, MD, Retina Diagnostic & Treatment Associates, LLC
    • Study Chair: Andrew Strong, Ph.D, QLT Inc.
    • Study Director: Oscar Cuzzani, MD, QLT Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00492284
    Other Study ID Numbers:
    • BPD OCR 022
    First Posted:
    Jun 27, 2007
    Last Update Posted:
    Jun 2, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    Macular Degeneration
    AMD
    CNV
    Choroidal neovascularization
    Photodynamic therapy
    CNV Secondary to Age Related Macular Degeneration
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic
    Dexamethasone
    Ranibizumab
    Verteporfin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Period Title: Overall Study
    STARTED 39 39 43 41
    COMPLETED 38 35 37 31
    NOT COMPLETED 1 4 6 10

    Baseline Characteristics

    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab Total
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter Total of all reporting groups
    Overall Participants 39 39 43 41 162
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    78
    (8)
    78
    (8)
    79
    (6)
    79
    (5)
    79
    (7)
    Sex: Female, Male (Count of Participants)
    Female
    20
    51.3%
    24
    61.5%
    23
    53.5%
    28
    68.3%
    95
    58.6%
    Male
    19
    48.7%
    15
    38.5%
    20
    46.5%
    13
    31.7%
    67
    41.4%
    Lesion composition (participants) [Number]
    Minimally classic
    6
    15.4%
    4
    10.3%
    9
    20.9%
    8
    19.5%
    27
    16.7%
    Occult no classic
    10
    25.6%
    16
    41%
    20
    46.5%
    18
    43.9%
    64
    39.5%
    Predominantly classic
    23
    59%
    19
    48.7%
    14
    32.6%
    15
    36.6%
    71
    43.8%
    Central retinal thickness (micron) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [micron]
    318.3
    (95.9)
    337.3
    (106.8)
    337.3
    (121.4)
    311.9
    (95.5)
    326.3
    (105.4)
    Lesion size (greatest linear dimension) (micron) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [micron]
    2778.8
    (1025.6)
    2740.1
    (846.1)
    2796.1
    (1122.8)
    3118.4
    (1155.7)
    2860.1
    (1049.4)
    Study Eye Best-corrected Visual Acuity Score (ETDRS chart) (Letters read on ETDRS chart) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Letters read on ETDRS chart]
    58.1
    (11.8)
    55.6
    (11.2)
    53.3
    (11.9)
    56.0
    (13.1)
    55.7
    (12.0)

    Outcome Measures

    1. Primary Outcome
    Title Mean Number of Retreatments (Day 0 Excluded)
    Description Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
    Time Frame Month 1 to Month 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Mean (95% Confidence Interval) [number of retreatments]
    3.97
    (3.12)
    3.00
    (2.55)
    4.05
    (2.93)
    5.39
    (2.97)
    2. Primary Outcome
    Title Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
    Description Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
    Time Frame Baseline to Month 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Mean (95% Confidence Interval) [Letters read on ETDRS chart]
    3.6
    (13.8)
    6.8
    (13.4)
    5.0
    (14.2)
    6.5
    (15.5)
    3. Secondary Outcome
    Title Mean Number of Retreatments (Day 0 Excluded)
    Description Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
    Time Frame Month 1 to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Mean (95% Confidence Interval) [number of retreatments]
    5.92
    4.34
    5.92
    8.68
    4. Secondary Outcome
    Title Mean Change From Baseline in Study Eye Best-Corrected VA Score
    Description Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
    Time Frame Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Mean (95% Confidence Interval) [Letters read on ETDRS chart]
    -0.2
    1.1
    -0.3
    4.4
    5. Secondary Outcome
    Title Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
    Description
    Time Frame Baseline to Month 12, Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Baseline to Month 12
    25.6
    65.6%
    30.8
    79%
    25.6
    59.5%
    24.4
    59.5%
    Baseline to Month 24
    20.5
    52.6%
    15.4
    39.5%
    16.3
    37.9%
    26.8
    65.4%
    6. Secondary Outcome
    Title Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
    Description
    Time Frame Baseline to Month 12, Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Baseline to Month 12
    64.1
    164.4%
    82.1
    210.5%
    69.8
    162.3%
    70.7
    172.4%
    Baseline to Month 24
    61.5
    157.7%
    66.7
    171%
    60.5
    140.7%
    70.7
    172.4%
    7. Secondary Outcome
    Title Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
    Description
    Time Frame Baseline to Month 12, Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Baseline to Month 12
    12.8
    32.8%
    7.7
    19.7%
    11.6
    27%
    7.3
    17.8%
    Baseline to Month 24
    20.5
    52.6%
    15.4
    39.5%
    20.9
    48.6%
    14.6
    35.6%
    8. Secondary Outcome
    Title Mean Change From Baseline in Central Retinal Thickness
    Description
    Time Frame Baseline to Month 12, Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Baseline to Month 12
    -115.9
    (97.4)
    -122.2
    (104.8)
    -137.8
    (122.3)
    -100.3
    (90.1)
    Baseline to Month 24
    -110.2
    (93.6)
    -123.9
    (97.1)
    -121.0
    (126.6)
    -103.1
    (99.1)
    9. Secondary Outcome
    Title Mean Change From Baseline in Lesion Size
    Description Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion
    Time Frame Baseline to Month 12, Baseline to Month 24

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat and last observation carried forward
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    Measure Participants 39 39 43 41
    Baseline to Month 12
    77.2
    (960.3)
    -20.4
    (1550.7)
    152.0
    (1415.5)
    -192.6
    (672.5)
    Baseline to Month 24
    94.8
    (865.1)
    -103.3
    (1326.1)
    -112.5
    (1209.4)
    -205.3
    (653.4)

    Adverse Events

    Time Frame Month 0 to Month 24/last visit
    Adverse Event Reporting Description
    Arm/Group Title 1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Arm/Group Description Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours] Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
    All Cause Mortality
    1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/39 (25.6%) 13/39 (33.3%) 15/43 (34.9%) 19/41 (46.3%)
    Blood and lymphatic system disorders
    Aplastic anemia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Anemia 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Blood dyscrasia 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Cardiac disorders
    AV block complete 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    AV block second degree 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Angina pectoris 0/39 (0%) 0 2/39 (5.1%) 2 1/43 (2.3%) 1 0/41 (0%) 0
    Arrhythmia 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 1/41 (2.4%) 1
    Arteriosclerosis 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Atrial fibrillation 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 2/41 (4.9%) 2
    Bundle Branch Block 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Cardiovascular disorder 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 0/41 (0%) 0
    Cerebral infarct 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Congestive Heart Failure 0/39 (0%) 0 2/39 (5.1%) 2 1/43 (2.3%) 1 3/41 (7.3%) 3
    Endocarditis 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Heart arrest 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Hypertension 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 3/41 (7.3%) 3
    Hypotension 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Postural Hypotension 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Syncope 0/39 (0%) 0 2/39 (5.1%) 2 0/43 (0%) 0 1/41 (2.4%) 1
    Tachycardia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Vascular anomaly 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Cardiomyopathy 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Coronary artery disorder 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Peripheral vascular disorder 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Pulmonary embolus 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Ventricular tachycardia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Endocrine disorders
    Adrenal disorder 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Eye disorders
    Increased intraocular pressure (study eye) 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Retinal detachment (study eye) 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Retinal tear (study eye) 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Vision decreased (study eye) 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 0/41 (0%) 0
    Visual field defect (study eye) 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Vitreous hemorrhage (study eye) 1/39 (2.6%) 1 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Gastrointestinal disorders
    Cholecystitis 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Cholelithiasis 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 2/41 (4.9%) 2
    Colitis 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Gastrointestinal carcinoma 0/39 (0%) 0 0/39 (0%) 0 2/43 (4.7%) 2 1/41 (2.4%) 1
    Gastrointestinal hemorrhage 0/39 (0%) 0 0/39 (0%) 0 2/43 (4.7%) 2 1/41 (2.4%) 1
    Gastrointestinal neoplasia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Intestinal perforation 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Pancreatitis 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Cholangitis 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Liver damage 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    General disorders
    Abdominal Pain 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Accidental Injury 0/39 (0%) 0 2/39 (5.1%) 2 1/43 (2.3%) 1 1/41 (2.4%) 1
    Anaphylactoid Reaction 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Cellulitis 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 1/41 (2.4%) 1
    Chest pain 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 1/41 (2.4%) 1
    Death 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Hernia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Infection 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 1/41 (2.4%) 1
    Infection bacterial 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Neck pain 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Pain 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Sepsis 0/39 (0%) 0 2/39 (5.1%) 2 0/43 (0%) 0 0/41 (0%) 0
    Viral infection 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Metabolism and nutrition disorders
    Dehydration 0/39 (0%) 0 1/39 (2.6%) 1 1/43 (2.3%) 1 1/41 (2.4%) 1
    Diabetes Mellitus 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Healing abnormal 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Hypoxia 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Hypomagnesemia 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Hyponatremia 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Arthritis 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Pathological Fracture 1/39 (2.6%) 1 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Pyogenic arthritis 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Bone neoplasm 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Rhabdomyolysis 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 2/41 (4.9%) 2
    Dizziness 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Psychosis 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Thinking abnormal 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Vertigo 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Confusion 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Convulsion 1/39 (2.6%) 1 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Renal and urinary disorders
    Acute kidney failure 0/39 (0%) 0 2/39 (5.1%) 3 0/43 (0%) 0 2/41 (4.9%) 2
    Kidney failure 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Reproductive system and breast disorders
    Breast carcinoma 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 2/41 (4.9%) 2
    Respiratory, thoracic and mediastinal disorders
    Aspiration pneumonia 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Asthma 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Dyspnea 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Lung edema 0/39 (0%) 0 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Pneumonia 1/39 (2.6%) 1 3/39 (7.7%) 3 0/43 (0%) 0 3/41 (7.3%) 3
    Apnea 0/39 (0%) 0 0/39 (0%) 0 0/43 (0%) 0 1/41 (2.4%) 1
    Lung disorder 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 1/41 (2.4%) 1
    Other (Not Including Serious) Adverse Events
    1/4 Fluence Triple Therapy 1/2 Fluence Triple Therapy 1/2 Fluence Double Therapy Ranibizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 36/39 (92.3%) 36/39 (92.3%) 36/43 (83.7%) 37/41 (90.2%)
    Blood and lymphatic system disorders
    Anemia 2/39 (5.1%) 2 3/39 (7.7%) 3 2/43 (4.7%) 2 2/41 (4.9%) 2
    Ecchymosis 1/39 (2.6%) 1 3/39 (7.7%) 3 2/43 (4.7%) 3 2/41 (4.9%) 5
    Cardiac disorders
    Hypertension 7/39 (17.9%) 9 2/39 (5.1%) 2 7/43 (16.3%) 7 5/41 (12.2%) 5
    Peripheral vascular disorder 0/39 (0%) 0 0/39 (0%) 0 3/43 (7%) 3 0/41 (0%) 0
    Syncope 1/39 (2.6%) 1 5/39 (12.8%) 5 2/43 (4.7%) 2 0/41 (0%) 0
    Bradycardia 2/39 (5.1%) 2 1/39 (2.6%) 1 1/43 (2.3%) 1 0/41 (0%) 0
    Cardiovascular disorder 2/39 (5.1%) 3 0/39 (0%) 0 2/43 (4.7%) 5 1/41 (2.4%) 1
    Cerebral ischemia 1/39 (2.6%) 1 3/39 (7.7%) 3 0/43 (0%) 0 1/41 (2.4%) 1
    Hemorrhage 0/39 (0%) 0 2/39 (5.1%) 2 0/43 (0%) 0 0/41 (0%) 0
    Vascular anomaly 0/39 (0%) 0 2/39 (5.1%) 2 1/43 (2.3%) 1 0/41 (0%) 0
    Eye disorders
    Age-related Macular Degeneration progression (fellow eye) 3/39 (7.7%) 3 8/39 (20.5%) 8 1/43 (2.3%) 1 2/41 (4.9%) 2
    Blepharitis (fellow eye) 0/39 (0%) 0 4/39 (10.3%) 4 0/43 (0%) 0 0/41 (0%) 0
    Blepharitis (study eye) 0/39 (0%) 0 4/39 (10.3%) 4 1/43 (2.3%) 1 1/41 (2.4%) 1
    Cataract (fellow eye) 2/39 (5.1%) 2 4/39 (10.3%) 4 2/43 (4.7%) 2 4/41 (9.8%) 4
    Cataract (study eye) 2/39 (5.1%) 2 4/39 (10.3%) 4 6/43 (14%) 6 1/41 (2.4%) 1
    Conjunctivitis (study eye) 2/39 (5.1%) 4 3/39 (7.7%) 3 2/43 (4.7%) 2 2/41 (4.9%) 2
    Corneal lesion (study eye) 0/39 (0%) 0 3/39 (7.7%) 3 0/43 (0%) 0 0/41 (0%) 0
    Eye itching (fellow eye) 1/39 (2.6%) 1 3/39 (7.7%) 3 0/43 (0%) 0 3/41 (7.3%) 3
    Eye itching (study eye) 2/39 (5.1%) 2 3/39 (7.7%) 3 1/43 (2.3%) 1 3/41 (7.3%) 4
    Eye pain (study eye) 7/39 (17.9%) 15 9/39 (23.1%) 11 9/43 (20.9%) 15 10/41 (24.4%) 23
    Increased intraocular pressure (study eye) 4/39 (10.3%) 4 4/39 (10.3%) 12 6/43 (14%) 8 6/41 (14.6%) 8
    Vision abnormal (study eye) 8/39 (20.5%) 10 1/39 (2.6%) 1 7/43 (16.3%) 10 4/41 (9.8%) 4
    Vision decreased (study eye) 5/39 (12.8%) 6 4/39 (10.3%) 4 6/43 (14%) 8 1/41 (2.4%) 1
    Visual field defect (study eye) 5/39 (12.8%) 5 0/39 (0%) 0 2/43 (4.7%) 2 4/41 (9.8%) 4
    Vitreous disorder (study eye) 4/39 (10.3%) 4 2/39 (5.1%) 2 3/43 (7%) 3 5/41 (12.2%) 5
    Conjunctivitis (fellow eye) 2/39 (5.1%) 3 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Dry eyes (fellow eye) 2/39 (5.1%) 2 0/39 (0%) 0 1/43 (2.3%) 1 1/41 (2.4%) 1
    Retinal disorder (fellow eye) 0/39 (0%) 0 2/39 (5.1%) 2 0/43 (0%) 0 1/41 (2.4%) 1
    Vitreous detachment (fellow eye) 1/39 (2.6%) 1 1/39 (2.6%) 1 0/43 (0%) 0 3/41 (7.3%) 3
    Diplopia (study eye) 0/39 (0%) 0 3/39 (7.7%) 3 1/43 (2.3%) 1 1/41 (2.4%) 1
    Dry eyes (study eye) 3/39 (7.7%) 3 1/39 (2.6%) 2 1/43 (2.3%) 1 1/41 (2.4%) 1
    Retinal disorder (study eye) 3/39 (7.7%) 3 4/39 (10.3%) 5 1/43 (2.3%) 1 1/41 (2.4%) 1
    Subconjunctival hemorrhage (study eye) 2/39 (5.1%) 2 2/39 (5.1%) 4 0/43 (0%) 0 2/41 (4.9%) 2
    Gastrointestinal disorders
    Cholelithiasis 0/39 (0%) 0 0/39 (0%) 0 1/43 (2.3%) 1 3/41 (7.3%) 3
    Nausea 0/39 (0%) 0 3/39 (7.7%) 3 4/43 (9.3%) 4 3/41 (7.3%) 3
    Constipation 3/39 (7.7%) 3 1/39 (2.6%) 1 2/43 (4.7%) 2 2/41 (4.9%) 2
    Diarrhea 2/39 (5.1%) 2 2/39 (5.1%) 2 2/43 (4.7%) 2 1/41 (2.4%) 2
    Dyspepsia 2/39 (5.1%) 3 0/39 (0%) 0 1/43 (2.3%) 2 1/41 (2.4%) 1
    Gastrointestinal disorder 1/39 (2.6%) 1 1/39 (2.6%) 1 4/43 (9.3%) 4 2/41 (4.9%) 2
    Periodontal abscess 2/39 (5.1%) 2 0/39 (0%) 0 1/43 (2.3%) 1 0/41 (0%) 0
    Vomiting 0/39 (0%) 0 2/39 (5.1%) 2 1/43 (2.3%) 1 2/41 (4.9%) 3
    Hypothyroidism 2/39 (5.1%) 2 3/39 (7.7%) 3 0/43 (0%) 0 0/41 (0%) 0
    General disorders
    Accidental Injury 6/39 (15.4%) 11 5/39 (12.8%) 9 7/43 (16.3%) 11 9/41 (22%) 15
    Asthenia 1/39 (2.6%) 1 4/39 (10.3%) 5 5/43 (11.6%) 7 3/41 (7.3%) 3
    Back pain 4/39 (10.3%) 4 2/39 (5.1%) 2 0/43 (0%) 0 1/41 (2.4%) 1
    Chest pain 2/39 (5.1%) 2 1/39 (2.6%) 1 2/43 (4.7%) 2 1/1 (100%) 1
    Flu syndrome 1/39 (2.6%) 1 2/39 (5.1%) 2 0/43 (0%) 0 4/41 (9.8%) 4
    Headache 3/39 (7.7%) 4 1/39 (2.6%) 2 4/43 (9.3%) 4 2/41 (4.9%) 2
    Infection 7/39 (17.9%) 9 7/39 (17.9%) 9 5/43 (11.6%) 8 8/41 (19.5%) 10
    Infusion-related back pain 1/39 (2.6%) 1 2/39 (5.1%) 5 4/43 (9.3%) 8 0/41 (0%) 0
    Injection site pain 1/39 (2.6%) 1 1/39 (2.6%) 1 3/43 (7%) 4 0/41 (0%) 0
    Pain 3/39 (7.7%) 3 4/39 (10.3%) 4 4/43 (9.3%) 4 5/41 (12.2%) 5
    Abdominal pain 1/39 (2.6%) 1 1/39 (2.6%) 1 2/43 (4.7%) 2 2/41 (4.9%) 2
    Allergic reaction 2/39 (5.1%) 2 2/39 (5.1%) 2 1/43 (2.3%) 1 3/41 (7.3%) 3
    Injection site extravasation 2/39 (5.1%) 2 1/39 (2.6%) 1 3/43 (7%) 3 0/41 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 2/39 (5.1%) 2 4/39 (10.3%) 4 2/43 (4.7%) 2 2/41 (4.9%) 2
    Hypercholesterolemia 1/39 (2.6%) 1 1/39 (2.6%) 1 3/43 (7%) 3 2/41 (4.9%) 2
    Hyperlipemia 0/39 (0%) 0 3/39 (7.7%) 3 1/43 (2.3%) 1 2/41 (4.9%) 2
    Peripheral edema 0/39 (0%) 0 3/39 (7.7%) 3 2/43 (4.7%) 2 2/41 (4.9%) 2
    Musculoskeletal and connective tissue disorders
    Arthritis 4/39 (10.3%) 4 4/39 (10.3%) 4 2/43 (4.7%) 2 1/41 (2.4%) 1
    Bone disorder 2/39 (5.1%) 2 1/39 (2.6%) 1 0/43 (0%) 0 1/41 (2.4%) 1
    Osteoporosis 0/39 (0%) 0 4/39 (10.3%) 4 3/43 (7%) 3 1/41 (2.4%) 1
    Pathological fracture 2/39 (5.1%) 2 0/39 (0%) 0 2/43 (4.7%) 2 0/41 (0%) 0
    Tenosynovitis 3/39 (7.7%) 3 1/39 (2.6%) 2 0/43 (0%) 0 0/41 (0%) 0
    Nervous system disorders
    Anxiety 3/39 (7.7%) 3 0/39 (0%) 0 2/43 (4.7%) 2 3/41 (7.3%) 3
    Dizziness 4/39 (10.3%) 4 5/39 (12.8%) 5 1/43 (2.3%) 1 1/41 (2.4%) 1
    Acute brain syndrome 2/39 (5.1%) 2 0/39 (0%) 0 0/43 (0%) 0 0/41 (0%) 0
    Dementia 2/39 (5.1%) 2 2/39 (5.1%) 2 1/43 (2.3%) 1 1/41 (2.4%) 1
    Depression 2/39 (5.1%) 2 1/39 (2.6%) 1 1/43 (2.3%) 1 1/41 (2.4%) 1
    Neuralgia 2/39 (5.1%) 3 1/39 (2.6%) 1 0/43 (0%) 0 0/41 (0%) 0
    Renal and urinary disorders
    Urinary tract infection 2/39 (5.1%) 8 3/39 (7.7%) 3 4/43 (9.3%) 4 6/41 (14.6%) 8
    Cystitis 0/39 (0%) 0 2/39 (5.1%) 3 0/43 (0%) 0 0/41 (0%) 0
    Kidney function abnormal 0/39 (0%) 0 2/39 (5.1%) 2 0/43 (0%) 0 2/41 (4.9%) 2
    Prostatic disorder 1/39 (2.6%) 1 2/39 (5.1%) 2 2/43 (4.7%) 3 2/41 (4.9%) 2
    Respiratory, thoracic and mediastinal disorders
    Bronchitis 3/39 (7.7%) 3 4/39 (10.3%) 4 2/43 (4.7%) 2 3/41 (7.3%) 3
    Cough increased 1/39 (2.6%) 1 2/39 (5.1%) 2 6/43 (14%) 6 2/41 (4.9%) 2
    Pneumonia 1/39 (2.6%) 2 3/39 (7.7%) 3 0/43 (0%) 0 3/41 (7.3%) 3
    Dyspnea 1/39 (2.6%) 1 2/39 (5.1%) 2 0/43 (0%) 0 2/41 (4.9%) 2
    Lung disorder 1/39 (2.6%) 1 0/39 (0%) 0 4/43 (9.3%) 4 1/41 (2.4%) 1
    Skin and subcutaneous tissue disorders
    Rash 1/39 (2.6%) 1 2/39 (5.1%) 2 1/43 (2.3%) 1 1/41 (2.4%) 1
    Skin carcinoma 2/39 (5.1%) 2 2/39 (5.1%) 2 1/43 (2.3%) 1 2/41 (4.9%) 2
    Skin disorder 0/39 (0%) 0 0/39 (0%) 0 2/43 (4.7%) 2 3/41 (7.3%) 4

    Limitations/Caveats

    Retreatment and vision analysis limitations, sample size, lack of standard monotherapy regimen used in practice, no treatment regimen approved by regulatory authorities, potential for bias in FA assessment, no central reading center, single-masked

    More Information

    Certain Agreements

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

    Publication materials will be reviewed and commented on by the Sponsor prior to submission for publication; Names of all Investigators and Sponsor representatives responsible for study design and analysis of results will be disclosed in the publication.

    Results Point of Contact

    Name/Title Medical Information Department
    Organization QLT Inc.
    Phone 1-800-663-5486
    Email medaff@qltinc.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00492284
    Other Study ID Numbers:
    • BPD OCR 022
    First Posted:
    Jun 27, 2007
    Last Update Posted:
    Jun 2, 2011
    Last Verified:
    May 1, 2011