drugset / Trial / NCT01969708
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
Phase 3
Completed
362 enrolled
The Emmes Company, LLC
Milton S. Hershey Medical Center · collabNational Eye Institute (NEI) · collabUniversity of Wisconsin, Madison · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2016-11
- Completion
- 2021-03
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Comparator | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |