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

NCT01969708 | Completed Phase 3 Results DMC

• 4 other identifiers: SCORE2U10EY023529U10EY023533U10EY023521
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 72

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.

Conditions

Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (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.

  Month 0 to 6

Secondary Outcomes (5)

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

  Month 0 to 6

• Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6

  Month 0 to 6

• Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness

  Month 0 to 6

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

  Month 0 to 6

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

  Month 0 to 6

Study Arms (2)

aflibercept

ACTIVE COMPARATOR

2.0 mg aflibercept every 4 weeks

Drug: aflibercept

bevacizumab

ACTIVE COMPARATOR

1.25 mg bevacizumab every 4 weeks

Drug: bevacizumab

Interventions

aflibercept DRUG

Also known as: EYLEA

aflibercept

bevacizumab DRUG

Also known as: Avastin

bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (72)

Retinal Consultants of AZ

Phoenix, Arizona, 85014, United States

Location

Retina Centers, P.C.

Tucson, Arizona, 85704, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

East Bay Retina Consultants, Inc.

Oakland, California, 94609, United States

Location

Southern California Desert Retina Consultants

Palm Desert, California, 92211, United States

Location

University of California Davis, Medical Center

Sacramento, California, 95817, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95819, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

New England Retina Associates

New London, Connecticut, 06320, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

University of Florida, Dept of Ophthalmology

Jacksonville, Florida, 32209, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Florida Retina Consultants

Winter Haven, Florida, 33880, United States

Location

Emory University Eye Center

Atlanta, Georgia, 30322, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina, P.C.

Marietta, Georgia, 30060, United States

Location

Illinois Eye and Ear Infirmary UIC Dept. of Ophthalmology

Chicago, Illinois, 60612, United States

Location

Thomas A. Ciulla, MD, PC

Indianapolis, Indiana, 46290, United States

Location

Sabates Eye Centers

Leawood, Kansas, 66211, United States

Location

Retina Associates, PA

Shawnee Mission, Kansas, 66204, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

The Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Elman Retina Group, P.A.

Glen Burnie, Maryland, 21061, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Elman Retina Group, P.A.

Pikesville, Maryland, 21208, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

TLC Eyecare & Laser Centers

Jackson, Michigan, 49202, United States

Location

VitreoRetinal Surgery

Minneapolis, Minnesota, 55435, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

UNMC Truhlsen Eye Institute

Omaha, Nebraska, 68198, United States

Location

Retina Consultants of Nevada

Las Vegas, Nevada, 89144, United States

Location

Delaware Valley Retina Associates

Lawrenceville, New Jersey, 08648, United States

Location

NJ Retina

New Brunswick, New Jersey, 08901, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620, United States

Location

University of Rochester Flaum Eye Institute

Rochester, New York, 14642, United States

Location

Retina Vitreous Surgeon of CNY, PC

Syracuse, New York, 13224, United States

Location

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

Charlotte, North Carolina, 28210, United States

Location

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

Statesville, North Carolina, 28677, United States

Location

Retina Associates of Cleveland, Inc.

Cleveland, Ohio, 44122, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Retina Northwest, PC

Portland, Oregon, 97210, United States

Location

Casey Eye Institute / OHSU

Portland, Oregon, 97239, United States

Location

Retina Vitreous Consultants

Monroeville, Pennsylvania, 15146, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Carolinas Centers for Sight, PC

Florence, South Carolina, 29501, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates, PC

Knoxville, Tennessee, 37909, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232-8808, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

The Retina Research Center

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

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

Houston, Texas, 77025, United States

Location

Retina & Vitreous of Texas

Houston, Texas, 77025, United States

Location

Retina Consultants of Houston, PA

Houston, Texas, 77030, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retinal Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

The Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (20)

• 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.

  PMID: 27450625 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.

  PMID: 27863843 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.

  PMID: 28492860 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.

  PMID: 29074161 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.

  PMID: 29476687 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.

  PMID: 29746405 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.

  PMID: 30589922 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.

  PMID: 32353052 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.

  PMID: 32828880 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.

  PMID: 34003964 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.

  PMID: 33373715 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.

  PMID: 28492910 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.

  PMID: 37943541 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.

  PMID: 37220815 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.

  PMID: 36584835 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.

  PMID: 35461831 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.

  PMID: 34709363 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.

  PMID: 33415354 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.

  PMID: 31600368 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.

  PMID: 31169862 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept; Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Principal Investigator of the SCORE2 Data Coordinating Center
• Organization: The Emmes Corporation

score2@emmes.com

301-251-1161

Study Officials

• Ingrid U Scott, M.D., M.P.H.

  Penn State College of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2021
• Last Updated: June 22, 2021
• Results First Posted: August 21, 2018

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: The time frame will be determined
• Access Criteria: Confidentiality agreements will be required before anonymized data will be shared.

Locations

US (72)