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Central Retinal Vein OcclusionPhase 3SCORE2NCT01969708

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

A Phase 3 study testing aflibercept and bevacizumab in people with Central Retinal Vein Occlusion, run by The Emmes Company, LLC at 72 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Retinal Vein Occlusion
What is being tested?
aflibercept and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
362 participants
Where
72 sitesUnited States
Study dates
Sep 2014to Mar 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United States72 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Emory University Eye Center

    Atlanta, Georgia, 30322

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • The Retina Research Center

    Austin, Texas, 78705

  • Elman Retina Group, PA

    Baltimore, Maryland, 21237

  • Charlotte Eye Ear Nose & Throat Associates, P.A.

    Charlotte, North Carolina, 28210

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Illinois Eye and Ear Infirmary UIC Dept. of Ophthalmology

    Chicago, Illinois, 60612

  • Retina Associates of Cleveland, Inc.

    Cleveland, Ohio, 44122

  • The Ohio State University

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • The Retina Group of Washington

    Fairfax, Virginia, 22031

  • Carolinas Centers for Sight, PC

    Florence, South Carolina, 29501

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Elman Retina Group, P.A.

    Glen Burnie, Maryland, 21061

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Charlotte Eye Ear Nose & Throat Associates, P.A.

    Houston, Texas, 77025

  • Retina & Vitreous of Texas

    Houston, Texas, 77025

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Thomas A. Ciulla, MD, PC

    Indianapolis, Indiana, 46290

  • TLC Eyecare & Laser Centers

    Jackson, Michigan, 49202

  • University of Florida, Dept of Ophthalmology

    Jacksonville, Florida, 32209

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37909

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Retina Consultants of Nevada

    Las Vegas, Nevada, 89144

  • Delaware Valley Retina Associates

    Lawrenceville, New Jersey, 08648

  • Sabates Eye Centers

    Leawood, Kansas, 66211

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Georgia Retina, P.C.

    Marietta, Georgia, 30060

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • VitreoRetinal Surgery

    Minneapolis, Minnesota, 55435

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232-8808

  • NJ Retina

    New Brunswick, New Jersey, 08901

  • New England Retina Associates

    New London, Connecticut, 06320

  • New York Eye and Ear Infirmary

    New York, New York, 10003

  • East Bay Retina Consultants, Inc.

    Oakland, California, 94609

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • UNMC Truhlsen Eye Institute

    Omaha, Nebraska, 68198

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Retinal Consultants of AZ

    Phoenix, Arizona, 85014

  • Elman Retina Group, P.A.

    Pikesville, Maryland, 21208

  • Retina Northwest, PC

    Portland, Oregon, 97210

  • Casey Eye Institute / OHSU

    Portland, Oregon, 97239

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • University of Rochester Flaum Eye Institute

    Rochester, New York, 14642

  • University of California Davis, Medical Center

    Sacramento, California, 95817

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95819

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • University of California, San Francisco

    San Francisco, California, 94143

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Retina Associates, PA

    Shawnee Mission, Kansas, 66204

  • The Retina Institute

    St Louis, Missouri, 63128

  • Charlotte Eye Ear Nose & Throat Associates, P.A.

    Statesville, North Carolina, 28677

  • Retina Vitreous Surgeon of CNY, PC

    Syracuse, New York, 13224

  • Retina Centers, P.C.

    Tucson, Arizona, 85704

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

  • Florida Retina Consultants

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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.

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.

Read the 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.
Being tested
aflibercept, bevacizumab
Medical subject headings
Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afliberceptDrug

    Also called EYLEA

  • bevacizumabDrug

    Also called Avastin

Study groups in NCT01969708
Study groupRoleWhat they receive
afliberceptActive comparator2.0 mg aflibercept every 4 weeks
Receives: Drug: aflibercept
bevacizumabActive comparator1.25 mg bevacizumab every 4 weeks
Receives: Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 0 to 6

Secondary outcomes (5)

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

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

    Measured: Month 0 to 6

  2. Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 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

    Measured: Month 0 to 6

  3. Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness

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

    Measured: Month 0 to 6

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

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

    Measured: Month 0 to 6

  5. Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces

    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

    Measured: Month 0 to 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2013 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2016
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969708
Sponsor's protocol ID
SCORE2
Other IDs
U10EY023529, U10EY023533, U10EY023521
Acronym
SCORE2
Status last verified
Jun 2021
First submitted
22 Oct 2013
Last updated
22 Jun 2021
Data monitoring committee
Yes
Individual data sharing
Yes: SCORE2 will follow specific plans for sharing of research data. After analysis, the final data set can be provided after appropriate procedures are implemented to preserve the anonymity of the records, specifically where protected health information (PHI) is required. Upon request, anonymized data will be shared under confidentiality agreements with researchers interested in the project.

Publications

  • 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.

    PubMed 27450625

  • 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.

    PubMed 27863843

  • 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.

    PubMed 28492860

  • 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.

    PubMed 29074161

  • 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.

    PubMed 29476687

  • 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.

    PubMed 29746405

  • 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.

    PubMed 30589922

  • 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.

    PubMed 32353052

  • 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.

    PubMed 32828880

  • 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.

    PubMed 34003964

  • 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.

    PubMed 33373715

  • 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.

    PubMed 28492910

  • 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.

    PubMed 37943541

  • 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.

    PubMed 37220815

  • 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.

    PubMed 36584835

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aflibercept and bevacizumab in people with Central Retinal Vein Occlusion, run by The Emmes Company, LLC at 72 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 (time frame: Month 0 to 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969708, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.

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