Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
NCT ID: NCT01969708
Last Updated: 2021-06-22
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
362 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2021-03-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Central Retinal Vein Occlusion
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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aflibercept
2.0 mg aflibercept every 4 weeks
Group Type
ACTIVE_COMPARATOR
aflibercept
Intervention Type
DRUG
bevacizumab
1.25 mg bevacizumab every 4 weeks
Group Type
ACTIVE_COMPARATOR
bevacizumab
Intervention Type
DRUG
Interventions
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aflibercept
Intervention Type
DRUG
bevacizumab
Intervention Type
DRUG
Other Intervention Names
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EYLEA
Avastin
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Eye Institute (NEI)
NIH
Sponsor Role
collaborator
Milton S. Hershey Medical Center
OTHER
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
collaborator
The Emmes Company, LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ingrid U Scott, M.D., M.P.H.
Role: STUDY_CHAIR
Penn State College of Medicine
Locations
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Retinal Consultants of AZ
Phoenix, Arizona, United States
Site Status
Retina Centers, P.C.
Tucson, Arizona, United States
Site Status
Northern California Retina Vitreous Associates
Mountain View, California, United States
Site Status
East Bay Retina Consultants, Inc.
Oakland, California, United States
Site Status
Southern California Desert Retina Consultants
Palm Desert, California, United States
Site Status
University of California Davis, Medical Center
Sacramento, California, United States
Site Status
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Site Status
University of California, San Francisco
San Francisco, California, United States
Site Status
New England Retina Associates
New London, Connecticut, United States
Site Status
Retina Group of Florida
Fort Lauderdale, Florida, United States
Site Status
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Site Status
University of Florida, Dept of Ophthalmology
Jacksonville, Florida, United States
Site Status
Florida Retina Consultants
Lakeland, Florida, United States
Site Status
Sarasota Retina Institute
Sarasota, Florida, United States
Site Status
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Site Status
Florida Retina Consultants
Winter Haven, Florida, United States
Site Status
Emory University Eye Center
Atlanta, Georgia, United States
Site Status
Southeast Retina Center
Augusta, Georgia, United States
Site Status
Georgia Retina, P.C.
Marietta, Georgia, United States
Site Status
Illinois Eye and Ear Infirmary UIC Dept. of Ophthalmology
Chicago, Illinois, United States
Site Status
Thomas A. Ciulla, MD, PC
Indianapolis, Indiana, United States
Site Status
Sabates Eye Centers
Leawood, Kansas, United States
Site Status
Retina Associates, PA
Shawnee Mission, Kansas, United States
Site Status
Retina Associates of Kentucky
Lexington, Kentucky, United States
Site Status
University of Kentucky
Lexington, Kentucky, United States
Site Status
Paducah Retinal Center
Paducah, Kentucky, United States
Site Status
Elman Retina Group, PA
Baltimore, Maryland, United States
Site Status
The Retina Group of Washington
Chevy Chase, Maryland, United States
Site Status
Elman Retina Group, P.A.
Glen Burnie, Maryland, United States
Site Status
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Site Status
Elman Retina Group, P.A.
Pikesville, Maryland, United States
Site Status
Henry Ford Health System
Detroit, Michigan, United States
Site Status
TLC Eyecare & Laser Centers
Jackson, Michigan, United States
Site Status
VitreoRetinal Surgery
Minneapolis, Minnesota, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
The Retina Institute
St Louis, Missouri, United States
Site Status
UNMC Truhlsen Eye Institute
Omaha, Nebraska, United States
Site Status
Retina Consultants of Nevada
Las Vegas, Nevada, United States
Site Status
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States
Site Status
NJ Retina
New Brunswick, New Jersey, United States
Site Status
New York Eye and Ear Infirmary
New York, New York, United States
Site Status
Retina Associates of Western New York
Rochester, New York, United States
Site Status
University of Rochester Flaum Eye Institute
Rochester, New York, United States
Site Status
Retina Vitreous Surgeon of CNY, PC
Syracuse, New York, United States
Site Status
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Site Status
Charlotte Eye Ear Nose & Throat Associates, P.A.
Statesville, North Carolina, United States
Site Status
Retina Associates of Cleveland, Inc.
Cleveland, Ohio, United States
Site Status
The Ohio State University
Columbus, Ohio, United States
Site Status
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Site Status
Retina Northwest, PC
Portland, Oregon, United States
Site Status
Casey Eye Institute / OHSU
Portland, Oregon, United States
Site Status
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States
Site Status
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Site Status
Carolinas Centers for Sight, PC
Florence, South Carolina, United States
Site Status
Palmetto Retina Center
West Columbia, South Carolina, United States
Site Status
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Site Status
Southeastern Retina Associates, PC
Knoxville, Tennessee, United States
Site Status
Tennessee Retina, PC
Nashville, Tennessee, United States
Site Status
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Site Status
Retina Research Institute of Texas
Abilene, Texas, United States
Site Status
Texas Retina Associates
Arlington, Texas, United States
Site Status
The Retina Research Center
Austin, Texas, United States
Site Status
Texas Retina Associates
Dallas, Texas, United States
Site Status
Charlotte Eye Ear Nose & Throat Associates, P.A.
Houston, Texas, United States
Site Status
Retina & Vitreous of Texas
Houston, Texas, United States
Site Status
Retina Consultants of Houston, PA
Houston, Texas, United States
Site Status
Valley Retina Institute, PA
McAllen, Texas, United States
Site Status
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Site Status
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Site Status
The Retina Group of Washington
Fairfax, Virginia, United States
Site Status
University of Wisconsin
Madison, Wisconsin, United States
Site Status
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Figueroa M; SCORE2 Investigator Group. SCORE2 Report 1: Techniques to Optimize Recruitment in Phase III Clinical Trials of Patients With Central Retinal Vein Occlusion. Am J Ophthalmol. 2016 Oct;170:25-31. doi: 10.1016/j.ajo.2016.07.011. Epub 2016 Jul 19.
Reference Type
BACKGROUND
Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Figueroa M, Dugel PU; SCORE2 Investigator Group. SCORE2 Report 2: Study Design and Baseline Characteristics. Ophthalmology. 2017 Feb;124(2):245-256. doi: 10.1016/j.ophtha.2016.09.038. Epub 2016 Nov 15.
Reference Type
BACKGROUND
Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, King J, Antoszyk AN, Peters MA, Tolentino M; SCORE2 Investigator Group. Baseline Factors Associated With 6-Month Visual Acuity and Retinal Thickness Outcomes in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Study Report 4. JAMA Ophthalmol. 2017 Jun 1;135(6):639-649. doi: 10.1001/jamaophthalmol.2017.1141.
Reference Type
BACKGROUND
Scott IU, Figueroa MJ, Oden NL, Ip MS, Blodi BA, VanVeldhuisen PC; SCORE2 Investigator Group. SCORE2 Report 5: Vision-Related Function in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion. Am J Ophthalmol. 2017 Dec;184:147-156. doi: 10.1016/j.ajo.2017.10.008. Epub 2017 Oct 23.
Reference Type
BACKGROUND
Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Altaweel M, Berinstein DM; SCORE2 Investigator Group. Comparison of Monthly vs Treat-and-Extend Regimens for Individuals With Macular Edema Who Respond Well to Anti-Vascular Endothelial Growth Factor Medications: Secondary Outcomes From the SCORE2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Apr 1;136(4):337-345. doi: 10.1001/jamaophthalmol.2017.6843.
Reference Type
BACKGROUND
Peterson JS, Rockwell K Jr, Scott IU, Ip MS, VanVeldhuisen PC, Blodi BA; SCORE2 Investigator Group. LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS. Retina. 2019 Sep;39(9):1802-1809. doi: 10.1097/IAE.0000000000002212.
Reference Type
BACKGROUND
Ip MS, Oden NL, Scott IU, VanVeldhuisen PC, Blodi BA, Ghuman T, Baker CW; SCORE2 Investigator Group. Month 12 Outcomes After Treatment Change at Month 6 Among Poor Responders to Aflibercept or Bevacizumab in Eyes With Macular Edema Secondary to Central or Hemiretinal Vein Occlusion: A Secondary Analysis of the SCORE2 Study. JAMA Ophthalmol. 2019 Mar 1;137(3):281-287. doi: 10.1001/jamaophthalmol.2018.6111.
Reference Type
BACKGROUND
Etheridge T, Dobson ETA, Wiedenmann M, Papudesu C, Scott IU, Ip MS, Eliceiri KW, Blodi BA, Domalpally A. A semi-automated machine-learning based workflow for ellipsoid zone analysis in eyes with macular edema: SCORE2 pilot study. PLoS One. 2020 Apr 30;15(4):e0232494. doi: 10.1371/journal.pone.0232494. eCollection 2020.
Reference Type
BACKGROUND
Hendrick A, VanVeldhuisen PC, Scott IU, King J, Blodi BA, Ip MS, Khurana RN, Oden NL; SCORE2 Investigator Group. SCORE2 Report 13: Intraretinal Hemorrhage Changes in Eyes With Central or Hemiretinal Vein Occlusion Managed With Aflibercept, Bevacizumab or Observation. Secondary Analysis of the SCORE and SCORE2 Clinical Trials. Am J Ophthalmol. 2021 Feb;222:185-193. doi: 10.1016/j.ajo.2020.08.030. Epub 2020 Aug 20.
Reference Type
BACKGROUND
Etheridge T, Dobson ETA, Wiedenmann M, Oden N, VanVeldhuisen P, Scott IU, Ip MS, Eliceiri KW, Blodi BA, Domalpally A. Ellipsoid Zone Defects in Retinal Vein Occlusion Correlates With Visual Acuity Prognosis: SCORE2 Report 14. Transl Vis Sci Technol. 2021 Mar 1;10(3):31. doi: 10.1167/tvst.10.3.31.
Reference Type
BACKGROUND
Etheridge T, Blodi B, Oden N, Van Veldhuisen P, Scott IU, Ip MS, Mititelu M, Domalpally A. Spectral Domain OCT Predictors of Visual Acuity in the Study of COmparative Treatments for REtinal Vein Occlusion 2: SCORE 2 Report 15. Ophthalmol Retina. 2021 Oct;5(10):991-998. doi: 10.1016/j.oret.2020.12.016. Epub 2020 Dec 26.
Reference Type
BACKGROUND
Scott IU, VanVeldhuisen PC, Ip MS, Blodi BA, Oden NL, Awh CC, Kunimoto DY, Marcus DM, Wroblewski JJ, King J; SCORE2 Investigator Group. Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion: The SCORE2 Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2072-2087. doi: 10.1001/jama.2017.4568.
Reference Type
RESULT
Aref AA, Scott IU, Oden NL, Ip MS, VanVeldhuisen PC, Blodi BA; SCORE and SCORE2 Study Investigator Groups. Intraocular Pressure in Eyes With Retinal Vein Occlusion Compared With Fellow Eyes: Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Report 27. JAMA Ophthalmol. 2023 Dec 1;141(12):1172-1174. doi: 10.1001/jamaophthalmol.2023.5159.
Reference Type
DERIVED
Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA; SCORE2 Investigator Group. SCORE2 Report 24: Nonlinear Relationship of Retinal Thickness and Visual Acuity in Central Retinal and Hemiretinal Vein Occlusion. Ophthalmology. 2023 Oct;130(10):1066-1072. doi: 10.1016/j.ophtha.2023.05.023. Epub 2023 May 21.
Reference Type
DERIVED
Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA; SCORE2 Investigator Group. SCORE2 Report 20: Relationship of Treatment Discontinuation With Visual Acuity and Central Subfield Thickness Outcomes. Am J Ophthalmol. 2023 Apr;248:157-163. doi: 10.1016/j.ajo.2022.12.026. Epub 2022 Dec 28.
Reference Type
DERIVED
Scott IU, VanVeldhuisen PC, Oden NL, Ip MS, Blodi BA; SCORE2 Investigator Group. Month 60 Outcomes After Treatment Initiation With Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion. Am J Ophthalmol. 2022 Aug;240:330-341. doi: 10.1016/j.ajo.2022.04.001. Epub 2022 Apr 21.
Reference Type
DERIVED
Aref AA, Scott IU, VanVeldhuisen PC, King J, Ip MS, Blodi BA, Oden NL; Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) Investigator Group. Intraocular Pressure-Related Events After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal Vein Occlusion or Hemiretinal Vein Occlusion: SCORE2 Report 16 on a Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Dec 1;139(12):1285-1291. doi: 10.1001/jamaophthalmol.2021.4395.
Reference Type
DERIVED
Khurana RN, Oden NL, VanVeldhuisen PC, Scott IU, Blodi BA, Ip MS; SCORE2 Investigator Group. Association between early and late response in eyes with central or hemiretinal vein occlusion treated with anti-VEGF agents : SCORE2 report 12: secondary analysis of the SCORE2 clinical trial. Graefes Arch Clin Exp Ophthalmol. 2021 Jul;259(7):1839-1851. doi: 10.1007/s00417-020-05018-7. Epub 2021 Jan 7.
Reference Type
DERIVED
Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Chan CK; SCORE2 Investigator Group. Month 24 Outcomes After Treatment Initiation With Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: SCORE2 Report 10: A Secondary Analysis of the SCORE2 Randomized Clinical Trial. JAMA Ophthalmol. 2019 Dec 1;137(12):1389-1398. doi: 10.1001/jamaophthalmol.2019.3947.
Reference Type
DERIVED
Scott IU, VanVeldhuisen PC, Barton F, Oden NL, Ip MS, Blodi BA, Worrall M, Fish GE; Study of Comparative Treatments for Retinal Vein Occlusion 2 Investigator Group. Patient-Reported Visual Function Outcomes After Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Due to Central Retinal or Hemiretinal Vein Occlusion: Preplanned Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Aug 1;137(8):932-938. doi: 10.1001/jamaophthalmol.2019.1519.
Reference Type
DERIVED
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Study Protocol
SCORE2 Protocol Version 3.0 (the Identifier for the appendices is PB2016-103334)
View DocumentOther Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
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