The SCORE2 Long-Term Follow-Up (SCORE2 LTF)

Project: Research project

Project Details

Description

Project Summary The SCORE2 Long-Term Follow-Up (SCORE2 LTF) proposal aims to describe long-term (3-, 4- and 5-year) outcomes of eyes from SCORE2 participants with CRVO or HRVO treated for macular edema with anti-vascular endothelial growth factor (anti-VEGF) therapy. Study outcomes include visual acuity, need for continuing treatment, development of complications of CRVO or HRVO, quality of life, and morphologic outcomes. Anti-VEGF therapy is the standard of care first-line treatment for vision loss attributable to macular edema due to CRVO or HRVO; despite this, there are no reliable data on long-term outcomes of eyes with CRVO treated with anti-VEGF therapy. In the SCORE2 LTF, participants followed in SCORE2 will return to one of 66 SCORE2 clinical sites at Years 3, 4 and 5 for measurement of visual acuity and intraocular pressure (IOP), slit-lamp and dilated funduscopic examinations, and spectral domain optical coherence tomography (SD-OCT). Approximately 6 months after each annual visit (at years 3.5 and 4.5), participants will be contacted by telephone for an update on any systemic and ocular events that have occurred since the annual visits. Since the SCORE2 LTF is intended to follow participants in a ?real-world? setting, SCORE2 investigators will not be provided with study drug or re-treatment recommendations for the management of the macular edema due to the CRVO or HRVO during SCORE2 LTF, thus allowing the gathering of data on types of treatment and treatment patterns that would typically be provided to CRVO and HRVO patients in a clinical setting. This information will be valuable to patients and their treating ophthalmologists with respect to what they can expect in terms of number of anti-VEGF treatments and visual acuity prognosis in patients with CRVO or HRVO. Fundus photography, fluorescein angiography, and quality of life assessment will be performed annually. Analyses will be performed to meet the following objectives: 1) compare visual acuity through 5 years for study participants treated initially with one of two anti-VEGF drugs (bevacizumab and aflibercept); 2) describe 3-, 4-, and 5-year visual acuity, morphologic, and quality of life outcomes, and safety profile, in eyes treated with anti-VEGF agents for macular edema due to CRVO or HRVO; 3) describe patterns of treatment for macular edema due to CRVO/HRVO (number, duration and type of treatments) and the temporal relationship with visual acuity, morphologic, and quality of life outcomes; 4) investigate the association between baseline factors and long-term visual acuity, morphologic, and quality of life outcomes; 5) compare of the natural history 3-year outcomes of the SCORE- CRVO trial with the 3-, 4- and 5-year outcomes of anti-VEGF-treated SCORE2 eyes.
StatusActive
Effective start/end date4/1/193/31/22

Funding

  • National Eye Institute: $802,369.00
  • National Eye Institute: $1,082,515.00

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