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Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)

Sponsor
The Emmes Company, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01969708
Collaborator
National Eye Institute (NEI) (NIH), Milton S. Hershey Medical Center (Other), University of Wisconsin, Madison (Other)
362
Enrollment
72
Locations
2
Arms
78
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which all participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as a non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25 mg) every 4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine if bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated with central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured at Month 6.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The primary objective of SCORE2 is to test for non-inferiority based on mean change from baseline in visual acuity letter score at Month 6 for eyes randomized to intravitreal bevacizumab every 4 weeks compared with eyes randomized to intravitreal aflibercept every 4 weeks using a non-inferiority margin of 5 letters.

Secondary objectives of SCORE2 are to:

  • compare the bevacizumab and the aflibercept groups with regards to central retinal thickness, as measured with spectral domain optical coherence tomography (SD-OCT), at Month 6 and change between baseline and Month 6;

  • assess Month 12 visual acuity and SD-OCT outcomes associated with different dosing strategies after Month 6 in participants who respond well to treatment;

  • assess Month 12 visual acuity and SD-OCT outcomes associated with alternative treatment strategies after Month 6 in participants who respond poorly to treatment;

  • compare area of retinal ischemia and rates of neovascular complications of CRVO in the bevacizumab vs. aflibercept groups;

  • add to our knowledge of the safety profile of these anti-vascular endothelial growth factor (VEGF) medications in the setting of eyes with macular edema secondary to CRVO;

  • conduct a cost effectiveness analysis comparing intravitreal bevacizumab to intravitreal aflibercept to assess the economic implications from a payor perspective using decision analytic methods.

Other exploratory aims of SCORE2 are to:

  • investigate the correlation of features identified through SD-OCT segmentation analysis, such as the inner segment-outer segment (IS-OS) junction (also known as the ellipsoid zone), with such characteristics as visual acuity and central retinal thickness;

  • investigate the correlation of area of peripheral retinal nonperfusion from widefield fluorescein angiography with visual acuity and central retinal thickness, and the prognostic value of baseline peripheral and central retina perfusion status in predicting disease course and treatment responsiveness;

  • investigate the correlation of features on adaptive optics imaging with such characteristics as visual acuity and central retinal thickness.

Study Design

Study Type:
Interventional
Actual Enrollment :
362 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Study of COmparative Treatments for REtinal Vein Occlusion 2 [SCORE2]: a Multicenter, Prospective, Randomized Non-inferiority Trial of Eyes With Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks With Intravitreal Aflibercept Every 4 Weeks.
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: aflibercept

2.0 mg aflibercept every 4 weeks

Drug: aflibercept
Other Names:
  • EYLEA

    		•
    Active Comparator: bevacizumab

    1.25 mg bevacizumab every 4 weeks

    Drug: bevacizumab
    Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 [Month 0 to 6]

      The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.

    Secondary Outcome Measures

    1. Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6 [Month 0 to 6]

      The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6

    2. Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6 [Month 0 to 6]

      The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6

    3. Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness [Month 0 to 6]

      The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography

    4. Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6 [Month 0 to 6]

      The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness

    5. Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces [Month 0 to 6]

      The measure is the number of study eyes with central subfield thickness <300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6

    Eligibility Criteria

    Criteria

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

    • Participants must have center-involved macular edema secondary to CRVO. Eyes may be enrolled as early as the time of diagnosis of the macular edema. The definition of CRVO used in SCORE will also be used for the purposes of SCORE2: a CRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g., telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in all 4 quadrants.

    • Due to the similarities of a hemiretinal vein occlusion (HRVO) to CRVO,HRVO will be classified as CRVO for the purposes of this clinical trial. Eyes classified as having a HRVO will be limited to no more than 25% of the planned sample size. A HRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in 5 or more clock hours but less than all 4 quadrants. Typically, a HRVO is a retinal vein occlusion that involves 2 altitudinal quadrants.

    • E-Early Treatment Diabetic Retinopathy Study (ETDRS)visual acuity score of greater than or equal to 19 letters (approximately 20/400) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol. The investigator must believe that a study eye with visual acuity between 19 and 33 letters is perfused.

    • Retinal thickness on SD-OCT measurement, defined as central subfield thickness of 300 µm or greater. If the SD-OCT measurement is taken from a Heidelberg Spectralis Machine, the central subfield thickness should be 320 µm or greater.

    • Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.

    Exclusion Criteria:

    • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers indicating difficulty in long term follow-up, likelihood of survival of less than 12 months).

    • Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at time of study entry.

    • History of allergy to any anti-VEGF agent, corticosteroid, or component of the delivery vehicle.

    • The participant will be moving out of the area of the clinical site to an area not covered by another clinical site during the 12 months of the study.

    • Positive urine pregnancy test: all women of childbearing potential (those who are pre-menopausal and not surgically sterilized) may participate only if they have a negative urine pregnancy test, and if they do not intend to become pregnant during the timeframe of the study. Women who are sexually active with a male partner must agree to use at least one of the following birth control methods: hormonal therapy such as oral, implantable or injectable chemical contraceptives; mechanical therapy such as spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner.

    • Women who are breast-feeding.

    • Examination evidence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT thought to be contributing to macular edema.

    • An eye that, in the investigator's opinion, would not benefit from resolution of macular edema such as eyes with foveal atrophy, dense pigmentary changes or dense subfoveal hard exudates.

    • Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, iris neovascularization, Irvine-Gass Syndrome, prior macula-off rhegmatogenous retinal detachment).

    • Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract).

    • History of laser photocoagulation for macular edema within 3 months prior to randomization.

    • History of intravitreal corticosteroid within 4 months of randomization.

    • Intravitreal anti-VEGF injection within 2 months of randomization. Note: Enrollment will be limited to no more than 25% of the planned sample size with any history of anti-VEGF treatment. Once this number of eyes has been enrolled, any history of anti-VEGF treatment will be an exclusion criterion. For enrollment of study eyes with prior intravitreal anti-VEGF agents, in the opinion of the investigator, the treatment response to prior anti-VEGF treatment must be either incomplete or the study eye had developed recurrent CRVO-associated macular edema, such that the study eye would benefit from additional anti-VEGF treatment.

    • History of peribulbar or retrobulbar corticosteroid use for any reason within 2 months prior to randomization.

    • History of panretinal scatter photocoagulation (PRP) or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 3 months following randomization.

    • History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to randomization or anticipated within the next 6 months following randomization.

    • History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization.

    • Aphakia.

    • Presence of an anterior chamber intraocular lens

    • Examination evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis.

    • History of macular detachment.

    • Examination evidence of any diabetic retinopathy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of AZ Phoenix Arizona United States 85014
    2 Retina Centers, P.C. Tucson Arizona United States 85704
    3 Northern California Retina Vitreous Associates Mountain View California United States 94040
    4 East Bay Retina Consultants, Inc. Oakland California United States 94609
    5 Southern California Desert Retina Consultants Palm Desert California United States 92211
    6 University of California Davis, Medical Center Sacramento California United States 95817
    7 Retinal Consultants Medical Group, Inc. Sacramento California United States 95819
    8 University of California, San Francisco San Francisco California United States 94143
    9 New England Retina Associates New London Connecticut United States 06320
    10 Retina Group of Florida Fort Lauderdale Florida United States 33308
    11 National Ophthalmic Research Institute Fort Myers Florida United States 33912
    12 University of Florida, Dept of Ophthalmology Jacksonville Florida United States 32209
    13 Florida Retina Consultants Lakeland Florida United States 33805
    14 Sarasota Retina Institute Sarasota Florida United States 34239
    15 Center for Retina and Macular Disease Winter Haven Florida United States 33880
    16 Florida Retina Consultants Winter Haven Florida United States 33880
    17 Emory University Eye Center Atlanta Georgia United States 30322
    18 Southeast Retina Center Augusta Georgia United States 30909
    19 Georgia Retina, P.C. Marietta Georgia United States 30060
    20 Illinois Eye and Ear Infirmary UIC Dept. of Ophthalmology Chicago Illinois United States 60612
    21 Thomas A. Ciulla, MD, PC Indianapolis Indiana United States 46290
    22 Sabates Eye Centers Leawood Kansas United States 66211
    23 Retina Associates, PA Shawnee Mission Kansas United States 66204
    24 Retina Associates of Kentucky Lexington Kentucky United States 40509
    25 University of Kentucky Lexington Kentucky United States 40536
    26 Paducah Retinal Center Paducah Kentucky United States 42001
    27 Elman Retina Group, PA Baltimore Maryland United States 21237
    28 The Retina Group of Washington Chevy Chase Maryland United States 20815
    29 Elman Retina Group, P.A. Glen Burnie Maryland United States 21061
    30 Cumberland Valley Retina Consultants Hagerstown Maryland United States 21740
    31 Elman Retina Group, P.A. Pikesville Maryland United States 21208
    32 Henry Ford Health System Detroit Michigan United States 48202
    33 TLC Eyecare & Laser Centers Jackson Michigan United States 49202
    34 VitreoRetinal Surgery Minneapolis Minnesota United States 55435
    35 Mayo Clinic Rochester Minnesota United States 55905
    36 The Retina Institute Saint Louis Missouri United States 63128
    37 UNMC Truhlsen Eye Institute Omaha Nebraska United States 68198
    38 Retina Consultants of Nevada Las Vegas Nevada United States 89144
    39 Delaware Valley Retina Associates Lawrenceville New Jersey United States 08648
    40 NJ Retina New Brunswick New Jersey United States 08901
    41 New York Eye and Ear Infirmary New York New York United States 10003
    42 Retina Associates of Western New York Rochester New York United States 14620
    43 University of Rochester Flaum Eye Institute Rochester New York United States 14642
    44 Retina Vitreous Surgeon of CNY, PC Syracuse New York United States 13224
    45 Charlotte Eye Ear Nose & Throat Associates, P.A. Charlotte North Carolina United States 28210
    46 Charlotte Eye Ear Nose & Throat Associates, P.A. Statesville North Carolina United States 28677
    47 Retina Associates of Cleveland, Inc. Cleveland Ohio United States 44122
    48 The Ohio State University Columbus Ohio United States 43212
    49 Dean McGee Eye Institute Oklahoma City Oklahoma United States 73104
    50 Retina Northwest, PC Portland Oregon United States 97210
    51 Casey Eye Institute / OHSU Portland Oregon United States 97239
    52 Retina Vitreous Consultants Monroeville Pennsylvania United States 15146
    53 Scheie Eye Institute Philadelphia Pennsylvania United States 19104
    54 Carolinas Centers for Sight, PC Florence South Carolina United States 29501
    55 Palmetto Retina Center West Columbia South Carolina United States 29169
    56 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
    57 Southeastern Retina Associates, PC Knoxville Tennessee United States 37909
    58 Tennessee Retina, PC Nashville Tennessee United States 37203
    59 Vanderbilt Eye Institute Nashville Tennessee United States 37232-8808
    60 Retina Research Institute of Texas Abilene Texas United States 79606
    61 Texas Retina Associates Arlington Texas United States 76012
    62 The Retina Research Center Austin Texas United States 78705
    63 Texas Retina Associates Dallas Texas United States 75231
    64 Charlotte Eye Ear Nose & Throat Associates, P.A. Houston Texas United States 77025
    65 Retina & Vitreous of Texas Houston Texas United States 77025
    66 Retina Consultants of Houston, PA Houston Texas United States 77030
    67 Valley Retina Institute, PA McAllen Texas United States 78503
    68 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
    69 Retinal Consultants of San Antonio San Antonio Texas United States 78240
    70 The Retina Group of Washington Fairfax Virginia United States 22031
    71 University of Wisconsin Madison Wisconsin United States 53705
    72 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • The Emmes Company, LLC
    • National Eye Institute (NEI)
    • Milton S. Hershey Medical Center
    • University of Wisconsin, Madison

    Investigators

    • Study Chair: Ingrid U Scott, M.D., M.P.H., Penn State College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The Emmes Company, LLC
    ClinicalTrials.gov Identifier:
    NCT01969708
    Other Study ID Numbers:
    • SCORE2
    • U10EY023529
    • U10EY023533
    • U10EY023521
    First Posted:
    Oct 25, 2013
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Retinal Vein Occlusion
    Bevacizumab
    Aflibercept

    Study Results

    Participant Flow

    Recruitment Details The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab.
    Pre-assignment Detail Participants were assigned to a treatment arm at enrollment.
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Period Title: Overall Study
    STARTED 180 182
    COMPLETED 175 173
    NOT COMPLETED 5 9

    Baseline Characteristics

    Arm/Group Title Aflibercept Bevacizumab Total
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab Total of all reporting groups
    Overall Participants 180 182 362
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    67
    37.2%
    67
    36.8%
    134
    37%
    >=65 years
    113
    62.8%
    115
    63.2%
    228
    63%
    Sex: Female, Male (Count of Participants)
    Female
    82
    45.6%
    75
    41.2%
    157
    43.4%
    Male
    98
    54.4%
    107
    58.8%
    205
    56.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    16
    8.9%
    22
    12.1%
    38
    10.5%
    Not Hispanic or Latino
    164
    91.1%
    160
    87.9%
    324
    89.5%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    8
    4.4%
    2
    1.1%
    10
    2.8%
    Asian
    4
    2.2%
    2
    1.1%
    6
    1.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    28
    15.6%
    26
    14.3%
    54
    14.9%
    White
    132
    73.3%
    146
    80.2%
    278
    76.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    8
    4.4%
    6
    3.3%
    14
    3.9%
    Region of Enrollment (participants) [Number]
    United States
    180
    100%
    182
    100%
    362
    100%
    Visual Acuity Letter Score (VALS) of Study Eye (letters read) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [letters read]
    50.3
    (15.2)
    50.4
    (15.3)
    50.3
    (15.2)
    Time between diagnosis of macular edema and randomization (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    8
    (17)
    5
    (10)
    7
    (14)
    Spectral Domain-Optical Coherence Tomography (SD-OCT) central subfield thickness (um) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [um]
    652.4
    (214.6)
    678.2
    (233.3)
    665.5
    (224.4)
    Prior anti-vascular endothelial growth factor (VEGF) treatment (Count of Participants)
    Count of Participants [Participants]
    65
    36.1%
    56
    30.8%
    121
    33.4%
    Prior intravitreal steroid use (Count of Participants)
    Count of Participants [Participants]
    16
    8.9%
    12
    6.6%
    28
    7.7%
    Hemiretinal vein occlusion (Count of Participants)
    Count of Participants [Participants]
    26
    14.4%
    31
    17%
    57
    15.7%
    Cataract extraction (Count of Participants)
    Count of Participants [Participants]
    43
    23.9%
    55
    30.2%
    98
    27.1%
    History of cataract (Count of Participants)
    Count of Participants [Participants]
    108
    60%
    95
    52.2%
    203
    56.1%
    Diabetes mellitus type 1 (Count of Participants)
    Count of Participants [Participants]
    1
    0.6%
    0
    0%
    1
    0.3%
    Diabetes mellitus type 2 (Count of Participants)
    Count of Participants [Participants]
    54
    30%
    59
    32.4%
    113
    31.2%
    Hypertensive (Count of Participants)
    Count of Participants [Participants]
    140
    77.8%
    138
    75.8%
    278
    76.8%
    Coronary artery disease (Count of Participants)
    Count of Participants [Participants]
    26
    14.4%
    30
    16.5%
    56
    15.5%
    National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 overall score (total score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [total score]
    77
    (15)
    77
    (17)
    77
    (16)

    Outcome Measures

    1. Primary Outcome
    Title Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6
    Description The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with visual acuity letter score recorded at Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 175 173
    Mean (95% Confidence Interval) [letters read]
    18.9
    18.6
    2. Secondary Outcome
    Title Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6
    Description The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with visual acuity letter score recorded at Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 175 173
    Number [study eyes]
    114
    106
    3. Secondary Outcome
    Title Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6
    Description The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with visual acuity letter score recorded at Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 175 173
    Number [study eyes]
    101
    99
    4. Secondary Outcome
    Title Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness
    Description The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with central subfield thickness recorded at baseline and Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 164 171
    Mean (95% Confidence Interval) [um]
    231.3
    287.9
    5. Secondary Outcome
    Title Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6
    Description The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with central subfield thickness recorded at baseline and Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 164 171
    Mean (95% Confidence Interval) [um]
    -425
    -387
    6. Secondary Outcome
    Title Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces
    Description The measure is the number of study eyes with central subfield thickness <300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6
    Time Frame Month 0 to 6

    Outcome Measure Data

    Analysis Population Description
    All participants with central subfield thickness recorded at Month 6
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    Measure Participants 169 172
    Number [study eyes]
    92
    49

    Adverse Events

    Time Frame Month 0 to 6
    Adverse Event Reporting Description
    Arm/Group Title Aflibercept Bevacizumab
    Arm/Group Description 2.0 mg aflibercept every 4 weeks aflibercept 1.25 mg bevacizumab every 4 weeks bevacizumab
    All Cause Mortality
    Aflibercept Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/180 (0.6%) 1/182 (0.5%)
    Serious Adverse Events
    Aflibercept Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/180 (7.8%) 14/182 (7.7%)
    Blood and lymphatic system disorders
    Hypercoagulation 0/180 (0%) 0 1/182 (0.5%) 1
    Cardiac disorders
    Acute myocardial infarction 0/180 (0%) 0 1/182 (0.5%) 1
    Atrial fibrillation 0/180 (0%) 0 1/182 (0.5%) 2
    Cardiac failure congestive 1/180 (0.6%) 1 0/182 (0%) 0
    Myocardial infarction 1/180 (0.6%) 1 1/182 (0.5%) 1
    Ear and labyrinth disorders
    Vertigo 0/180 (0%) 0 1/182 (0.5%) 1
    Eye disorders
    Non-infectious endophthalmitis 0/180 (0%) 0 1/182 (0.5%) 1
    Gastrointestinal disorders
    Gastrointestinal haemorrhage 0/180 (0%) 0 1/182 (0.5%) 1
    Immune system disorders
    Hypersensitivity 0/180 (0%) 0 1/182 (0.5%) 1
    Infections and infestations
    Bronchitis 1/180 (0.6%) 1 0/182 (0%) 0
    Clostridium difficile colitis 0/180 (0%) 0 1/182 (0.5%) 1
    Diabetic foot infection 1/180 (0.6%) 1 0/182 (0%) 0
    Escherichia infection 1/180 (0.6%) 1 0/182 (0%) 0
    Meningitis streptococcal 0/180 (0%) 0 1/182 (0.5%) 1
    Pneumonia 0/180 (0%) 0 2/182 (1.1%) 2
    Sepsis 0/180 (0%) 0 1/182 (0.5%) 1
    Injury, poisoning and procedural complications
    Ankle fracture 1/180 (0.6%) 1 0/182 (0%) 0
    Investigations
    Blood sodium decreased 0/180 (0%) 0 1/182 (0.5%) 1
    Metabolism and nutrition disorders
    Dehydration 0/180 (0%) 0 1/182 (0.5%) 1
    Hypoglycaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis 1/180 (0.6%) 1 0/182 (0%) 0
    Osteoarthritis 1/180 (0.6%) 1 0/182 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoplasmacytoid lymphoma/immunocytoma 0/180 (0%) 0 1/182 (0.5%) 1
    Neoplasm malignant 0/180 (0%) 0 1/182 (0.5%) 1
    Oesophageal adenocarcinoma 1/180 (0.6%) 1 0/182 (0%) 0
    Renal cancer 1/180 (0.6%) 1 0/182 (0%) 0
    Waldenstrom's macroglobulinaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Nervous system disorders
    Cerebrovascular accident 1/180 (0.6%) 1 0/182 (0%) 0
    Cerebrovascular stenosis 0/180 (0%) 0 1/182 (0.5%) 1
    Psychiatric disorders
    Alcohol abuse 0/180 (0%) 0 1/182 (0.5%) 1
    Mental status changes 1/180 (0.6%) 1 0/182 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 1/180 (0.6%) 1 0/182 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/180 (0.6%) 1 0/182 (0%) 0
    Chronic obstructive pulmonary disease 0/180 (0%) 0 1/182 (0.5%) 1
    Pulmonary embolism 1/180 (0.6%) 1 0/182 (0%) 0
    Surgical and medical procedures
    Hernia repair 0/180 (0%) 0 1/182 (0.5%) 1
    Vascular disorders
    Hypertension 1/180 (0.6%) 1 0/182 (0%) 0
    Hypertensive crisis 1/180 (0.6%) 1 0/182 (0%) 0
    Peripheral vascular disorder 1/180 (0.6%) 1 0/182 (0%) 0
    Other (Not Including Serious) Adverse Events
    Aflibercept Bevacizumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 82/180 (45.6%) 98/182 (53.8%)
    Blood and lymphatic system disorders
    Anaemia 1/180 (0.6%) 1 0/182 (0%) 0
    Cardiac disorders
    Bradycardia 0/180 (0%) 0 1/182 (0.5%) 1
    Cardiac failure congestive 1/180 (0.6%) 1 0/182 (0%) 0
    Myocardial infarction 1/180 (0.6%) 1 0/182 (0%) 0
    Ear and labyrinth disorders
    Vertigo 1/180 (0.6%) 1 0/182 (0%) 0
    Vertigo positional 1/180 (0.6%) 1 0/182 (0%) 0
    Endocrine disorders
    Hypothyroidism 1/180 (0.6%) 1 0/182 (0%) 0
    Eye disorders
    Angle closure glaucoma 0/180 (0%) 0 2/182 (1.1%) 2
    Blepharitis 0/180 (0%) 0 1/182 (0.5%) 1
    Cataract 4/180 (2.2%) 4 2/182 (1.1%) 3
    Cataract nuclear 0/180 (0%) 0 1/182 (0.5%) 1
    Charles Bonnet syndrome 1/180 (0.6%) 1 0/182 (0%) 0
    Conjunctival haemorrhage 4/180 (2.2%) 4 14/182 (7.7%) 16
    Conjunctival hyperaemia 1/180 (0.6%) 4 1/182 (0.5%) 1
    Conjunctival oedema 0/180 (0%) 0 1/182 (0.5%) 1
    Diabetic retinopathy 0/180 (0%) 0 1/182 (0.5%) 1
    Dry eye 1/180 (0.6%) 2 2/182 (1.1%) 3
    Eye irritation 3/180 (1.7%) 3 2/182 (1.1%) 3
    Eye pain 6/180 (3.3%) 8 3/182 (1.6%) 3
    Eye pruritus 1/180 (0.6%) 1 1/182 (0.5%) 1
    Eye swelling 0/180 (0%) 0 2/182 (1.1%) 2
    Eyelid disorder 0/180 (0%) 0 1/182 (0.5%) 1
    Eyelid pain 1/180 (0.6%) 1 0/182 (0%) 0
    Foreign body sensation in eyes 1/180 (0.6%) 3 1/182 (0.5%) 1
    Glaucoma 0/180 (0%) 0 1/182 (0.5%) 1
    Keratopathy 1/180 (0.6%) 1 0/182 (0%) 0
    Lacrimation increased 1/180 (0.6%) 1 1/182 (0.5%) 2
    Macular hole 1/180 (0.6%) 1 0/182 (0%) 0
    Macular ischaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Macular oedema 0/180 (0%) 0 1/182 (0.5%) 1
    Maculopathy 1/180 (0.6%) 1 0/182 (0%) 0
    Metamorphopsia 0/180 (0%) 0 1/182 (0.5%) 1
    Ocular discomfort 0/180 (0%) 0 1/182 (0.5%) 1
    Ocular hyperaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Ocular hypertension 1/180 (0.6%) 2 1/182 (0.5%) 1
    Ophthalmoplegia 0/180 (0%) 0 1/182 (0.5%) 1
    Optic disc hyperaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Papilloedema 0/180 (0%) 0 1/182 (0.5%) 1
    Photophobia 1/180 (0.6%) 1 1/182 (0.5%) 2
    Photopsia 0/180 (0%) 0 1/182 (0.5%) 1
    Posterior capsule opacification 0/180 (0%) 0 1/182 (0.5%) 1
    Retinal collateral vessels 0/180 (0%) 0 1/182 (0.5%) 1
    Retinal exudates 2/180 (1.1%) 2 3/182 (1.6%) 3
    Retinal haemorrhage 0/180 (0%) 0 3/182 (1.6%) 3
    Retinal vascular disorder 0/180 (0%) 0 1/182 (0.5%) 1
    Retinal vein occlusion 2/180 (1.1%) 2 2/182 (1.1%) 2
    Subretinal fluid 1/180 (0.6%) 1 0/182 (0%) 0
    Vision blurred 1/180 (0.6%) 1 5/182 (2.7%) 8
    Visual acuity reduced 3/180 (1.7%) 4 7/182 (3.8%) 7
    Visual impairment 1/180 (0.6%) 1 0/182 (0%) 0
    Vitreous adhesions 1/180 (0.6%) 1 0/182 (0%) 0
    Vitreous detachment 6/180 (3.3%) 6 3/182 (1.6%) 3
    Vitreous floaters 6/180 (3.3%) 6 8/182 (4.4%) 8
    Vitreous opacities 0/180 (0%) 0 1/182 (0.5%) 1
    Gastrointestinal disorders
    Abdominal pain 0/180 (0%) 0 1/182 (0.5%) 1
    Constipation 1/180 (0.6%) 1 1/182 (0.5%) 1
    Haematochezia 1/180 (0.6%) 1 0/182 (0%) 0
    Large intestine polyp 1/180 (0.6%) 1 0/182 (0%) 0
    Nausea 2/180 (1.1%) 2 1/182 (0.5%) 1
    Stomatitis 1/180 (0.6%) 1 0/182 (0%) 0
    Vomiting 0/180 (0%) 0 1/182 (0.5%) 1
    General disorders
    Asthenia 0/180 (0%) 0 2/182 (1.1%) 2
    Catheter site haemorrhage 0/180 (0%) 0 1/182 (0.5%) 1
    Chest pain 3/180 (1.7%) 3 0/182 (0%) 0
    Cyst 0/180 (0%) 0 1/182 (0.5%) 1
    Facial pain 1/180 (0.6%) 1 0/182 (0%) 0
    Pyrexia 0/180 (0%) 0 2/182 (1.1%) 2
    Immune system disorders
    Drug hypersensitivity 0/180 (0%) 0 1/182 (0.5%) 1
    Hypersensitivity 0/180 (0%) 0 1/182 (0.5%) 1
    Sarcoidosis 0/180 (0%) 0 1/182 (0.5%) 1
    Seasonal allergy 3/180 (1.7%) 3 0/182 (0%) 0
    Infections and infestations
    Acarodermatitis 0/180 (0%) 0 1/182 (0.5%) 1
    Atypical pneumonia 0/180 (0%) 0 1/182 (0.5%) 1
    Bacterial infection 0/180 (0%) 0 1/182 (0.5%) 1
    Bronchitis 4/180 (2.2%) 4 2/182 (1.1%) 2
    Bronchitis viral 1/180 (0.6%) 1 0/182 (0%) 0
    Cellulitis 1/180 (0.6%) 1 0/182 (0%) 0
    Clostridium difficile colitis 1/180 (0.6%) 1 0/182 (0%) 0
    Clostridium difficile infection 0/180 (0%) 0 1/182 (0.5%) 1
    Diverticulitis 1/180 (0.6%) 1 1/182 (0.5%) 1
    Gastroenteritis viral 2/180 (1.1%) 2 0/182 (0%) 0
    Gingivitis 1/180 (0.6%) 1 0/182 (0%) 0
    Haematoma infection 1/180 (0.6%) 1 0/182 (0%) 0
    Herpes zoster 1/180 (0.6%) 1 0/182 (0%) 0
    Influenza 1/180 (0.6%) 1 1/182 (0.5%) 1
    Localised infection 1/180 (0.6%) 1 0/182 (0%) 0
    Nasopharyngitis 3/180 (1.7%) 3 6/182 (3.3%) 6
    Pharyngitis streptococcal 0/180 (0%) 0 1/182 (0.5%) 1
    Pneumonia 1/180 (0.6%) 1 0/182 (0%) 0
    Respiratory tract congestion 1/180 (0.6%) 1 0/182 (0%) 0
    Respiratory tract infection 0/180 (0%) 0 2/182 (1.1%) 2
    Sinusitis 2/180 (1.1%) 2 5/182 (2.7%) 5
    Tinea pedis 0/180 (0%) 0 1/182 (0.5%) 1
    Tooth infection 1/180 (0.6%) 1 0/182 (0%) 0
    Upper respiratory tract infection 2/180 (1.1%) 2 2/182 (1.1%) 2
    Urinary tract infection 3/180 (1.7%) 3 6/182 (3.3%) 6
    Injury, poisoning and procedural complications
    Ankle fracture 0/180 (0%) 0 1/182 (0.5%) 1
    Arteriovenous fistula aneurysm 1/180 (0.6%) 1 0/182 (0%) 0
    Cataract traumatic 1/180 (0.6%) 1 0/182 (0%) 0
    Contusion 2/180 (1.1%) 2 0/182 (0%) 0
    Corneal abrasion 0/180 (0%) 0 1/182 (0.5%) 1
    Fall 2/180 (1.1%) 2 5/182 (2.7%) 5
    Joint injury 0/180 (0%) 0 1/182 (0.5%) 1
    Ligament sprain 0/180 (0%) 0 1/182 (0.5%) 1
    Periorbital haemorrhage 0/180 (0%) 0 1/182 (0.5%) 1
    Procedural pain 1/180 (0.6%) 1 1/182 (0.5%) 1
    Tendon injury 1/180 (0.6%) 1 0/182 (0%) 0
    Tooth fracture 0/180 (0%) 0 1/182 (0.5%) 1
    Wound 1/180 (0.6%) 1 1/182 (0.5%) 1
    Wrist fracture 0/180 (0%) 0 1/182 (0.5%) 1
    Investigations
    Blood cholesterol increased 0/180 (0%) 0 1/182 (0.5%) 1
    Blood glucose increased 0/180 (0%) 0 1/182 (0.5%) 1
    Blood pressure increased 1/180 (0.6%) 1 3/182 (1.6%) 3
    Blood sodium decreased 0/180 (0%) 0 1/182 (0.5%) 1
    Intraocular pressure increased 1/180 (0.6%) 2 5/182 (2.7%) 5
    Metabolism and nutrition disorders
    Diabetes mellitus 1/180 (0.6%) 1 2/182 (1.1%) 2
    Gout 0/180 (0%) 0 1/182 (0.5%) 1
    Hypertriglyceridaemia 1/180 (0.6%) 1 0/182 (0%) 0
    Hypoglycaemia 0/180 (0%) 0 1/182 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/180 (1.7%) 3 2/182 (1.1%) 2
    Back pain 1/180 (0.6%) 1 3/182 (1.6%) 3
    Costochondritis 0/180 (0%) 0 1/182 (0.5%) 1
    Joint swelling 0/180 (0%) 0 1/182 (0.5%) 1
    Muscle spasms 0/180 (0%) 0 2/182 (1.1%) 2
    Muscular weakness 0/180 (0%) 0 1/182 (0.5%) 1
    Musculoskeletal stiffness 1/180 (0.6%) 1 0/182 (0%) 0
    Myalgia 0/180 (0%) 0 1/182 (0.5%) 1
    Osteoarthritis 0/180 (0%) 0 2/182 (1.1%) 2
    Pain in extremity 0/180 (0%) 0 2/182 (1.1%) 2
    Plantar fasciitis 0/180 (0%) 0 1/182 (0.5%) 1
    Rotator cuff syndrome 1/180 (0.6%) 1 0/182 (0%) 0
    Temporomandibular joint syndrome 0/180 (0%) 0 1/182 (0.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 1/180 (0.6%) 1 0/182 (0%) 0
    Bladder neoplasm 1/180 (0.6%) 1 0/182 (0%) 0
    Squamous cell carcinoma 0/180 (0%) 0 1/182 (0.5%) 1
    Nervous system disorders
    Carpal tunnel syndrome 0/180 (0%) 0 1/182 (0.5%) 1
    Cervical radiculopathy 1/180 (0.6%) 1 0/182 (0%) 0
    Dizziness 2/180 (1.1%) 2 2/182 (1.1%) 3
    Headache 2/180 (1.1%) 2 6/182 (3.3%) 6
    Metabolic encephalopathy 0/180 (0%) 0 1/182 (0.5%) 1
    Migraine 0/180 (0%) 0 1/182 (0.5%) 1
    Neuralgia 0/180 (0%) 0 1/182 (0.5%) 1
    Optic neuritis 0/180 (0%) 0 1/182 (0.5%) 1
    Parkinson's disease 1/180 (0.6%) 1 0/182 (0%) 0
    Polyneuropathy 0/180 (0%) 0 1/182 (0.5%) 1
    Sciatica 1/180 (0.6%) 1 1/182 (0.5%) 1
    Syncope 0/180 (0%) 0 2/182 (1.1%) 2
    Tremor 0/180 (0%) 0 1/182 (0.5%) 1
    Psychiatric disorders
    Anxiety 1/180 (0.6%) 1 1/182 (0.5%) 1
    Renal and urinary disorders
    Acute kidney injury 1/180 (0.6%) 1 2/182 (1.1%) 2
    Haematuria 0/180 (0%) 0 1/182 (0.5%) 1
    Urinary retention 0/180 (0%) 0 1/182 (0.5%) 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 1/180 (0.6%) 1 0/182 (0%) 0
    Prostatomegaly 0/180 (0%) 0 2/182 (1.1%) 2
    Vulva cyst 0/180 (0%) 0 1/182 (0.5%) 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 1/180 (0.6%) 1 0/182 (0%) 0
    Cough 3/180 (1.7%) 3 1/182 (0.5%) 1
    Dyspnoea 1/180 (0.6%) 1 0/182 (0%) 0
    Oropharyngeal pain 1/180 (0.6%) 1 1/182 (0.5%) 1
    Paranasal sinus discomfort 0/180 (0%) 0 1/182 (0.5%) 1
    Pulmonary hypertension 0/180 (0%) 0 1/182 (0.5%) 1
    Sleep apnoea syndrome 0/180 (0%) 0 1/182 (0.5%) 1
    Skin and subcutaneous tissue disorders
    Pruritus 0/180 (0%) 0 2/182 (1.1%) 2
    Rash pruritic 1/180 (0.6%) 1 0/182 (0%) 0
    Urticaria 1/180 (0.6%) 1 0/182 (0%) 0
    Surgical and medical procedures
    Endodontic procedure 1/180 (0.6%) 1 0/182 (0%) 0
    Peripheral nerve decompression 0/180 (0%) 0 1/182 (0.5%) 1
    Tooth extraction 0/180 (0%) 0 1/182 (0.5%) 1
    Vascular disorders
    Aneurysm 0/180 (0%) 0 1/182 (0.5%) 1
    Haematoma 1/180 (0.6%) 1 0/182 (0%) 0
    Hypertension 3/180 (1.7%) 3 5/182 (2.7%) 5

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Trial results can not be discussed until they have been made available to the public.

    Results Point of Contact

    Name/Title Principal Investigator of the SCORE2 Data Coordinating Center
    Organization The Emmes Corporation
    Phone 301-251-1161
    Email score2@emmes.com
    Responsible Party:
    The Emmes Company, LLC
    ClinicalTrials.gov Identifier:
    NCT01969708
    Other Study ID Numbers:
    • SCORE2
    • U10EY023529
    • U10EY023533
    • U10EY023521
    First Posted:
    Oct 25, 2013
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Jun 1, 2021