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SCORE2 Report 17: Macular thickness fluctuations in anti-VEGF-treated patients with central or hemiretinal vein occlusion

  • Retinal Disorders
  • Published:
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Abstract

Purpose

To evaluate macular thickness fluctuations and their association with visual acuity outcome in eyes with macular edema (ME) secondary to central (CRVO) or hemiretinal vein occlusion (HRVO) treated initially with intravitreal aflibercept or bevacizumab.

Methods

Post hoc analysis of 362 patients with ME secondary to CRVO or HRVO initially randomized to six monthly intravitreal injections of aflibercept or bevacizumab. Three spectral domain optical coherence tomography (SD-OCT) central subfield thickness (CST) fluctuation measures were investigated over Months 1–12: standard deviation (SD), number of turning points (T) for each participant, and a measure denoted as Zigzag reflecting the magnitude of alternating ups and downs in a participant’s CST. Main outcome measure is Month 12 visual acuity letter score (VALS).

Results

More fluctuations occurred in eyes randomized to bevacizumab than aflibercept: SD (59.98 vs 32.12; p < 0.0001), T (4.03 vs 3.53; p = 0.02) and Zigzag (24.91 vs 11.60; p = 0.0003). Month 12 VALS is significantly lower for the 4th (highest) quartile of the CST fluctuation measure than for the 1st (lowest) quartile for both SD (mean difference in VALS of 7.87; 95% confidence interval: 3.03, 12.70) and Zigzag (mean difference in VALS of 5.11; 95% confidence interval: 0.29, 9.93). SD and Zigzag quartiles were no longer significantly different after Month 1 VALS was added to the regression analysis.

Conclusions

Greater CST fluctuation as assessed by SD and Zigzag was negatively associated with Month 12 VALS. However, early post-treatment VALS is a stronger predictor of VALS outcomes than the CST fluctuation measures.

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Funding

Supported by the National Eye Institute (National Institutes of Health, Department of Health and Human Services) grants U10EY023529, U10EY023533, and U10EY023521. Support also provided in part by Regeneron, Inc and Allergan, Inc through donation of investigational drug. This work was supported in part by an unrestricted grant from Research to Prevent Blindness, Inc. to the University of Wisconsin Madison Department of Ophthalmology and Visual Sciences and to the Jules Stein Eye Institute and Doheny Eye Institute, Department of Ophthalmology at the University of California Los Angeles, CA.

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Authors and Affiliations

  1. Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA

    Ingrid U. Scott

  2. The Emmes Company, LLC, 401 N. Washington Street, Suite 700, Rockville, MD, USA

    Neal L. Oden & Paul C. VanVeldhuisen

  3. Doheny Eye Institute, University of California, Los Angeles, CA, USA

    Michael S. Ip

  4. University of Wisconsin Fundus Photograph Reading Center, Madison, WI, USA

    Barbara A. Blodi

Authors
  1. Ingrid U. Scott
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  2. Neal L. Oden
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  3. Paul C. VanVeldhuisen
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  4. Michael S. Ip
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  5. Barbara A. Blodi
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Consortia

for the SCORE2 Investigator Group

Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by NO and PVV and staff at the SCORE2 Data Coordinating Center.

Corresponding author

Correspondence to Paul C. VanVeldhuisen.

Ethics declarations

Conflict of interest

Neal L. Oden, Ph.D.: work supported by grant 1U10EY023529 from the National Eye Institute of the National Institutes of Health. Paul C. VanVeldhuisen, Ph.D.: work supported by grant 1U10EY023529 from the National Eye Institute of the National Institutes of Health. Ingrid U. Scott, M.D., M.P.H.: serves as Principal Investigator and Chair of SCORE2, which is funded by the National Eye Institute, has served as a consultant for Regeneron (Tarrytown, NJ), and has served on the Data and Safety Monitoring Committee of clinical trials sponsored by Novartis (Basel, Switzerland). Barbara A. Blodi, M.D.: No financial disclosures. Michael S. Ip, M.D.: Dr. Ip is a consultant for the following: Novartis (Basel, Switzerland), Genentech (South San Francisco, CA), Allergan (Irvine, CA), Regeneron (Tarrytown, NJ), RegenexBio (Rockville, MD), Apellis (Waltham, MA), Aerie Pharmaceuticals (Durham, NC), Alimera Sciences (Alpharetta, GA), Amgen (Thousand Oaks, CA), Cell Lineage Therapeutics (Carlsbad, CA), Clearside Biomedical (Alpharetta, GA).

Institutional review board approval

The protocol approval was obtained from either a site-specific or centralized IRB (Advarra, Columbia, Maryland).

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SCORE2 was registered on clinicaltrials.gov on October 25, 2013 and began enrollment in September 2014. The ClinicalTrials.gov Identifier is NCT01969708.

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Scott, I.U., Oden, N.L., VanVeldhuisen, P.C. et al. SCORE2 Report 17: Macular thickness fluctuations in anti-VEGF-treated patients with central or hemiretinal vein occlusion. Graefes Arch Clin Exp Ophthalmol 260, 1491–1500 (2022). https://doi.org/10.1007/s00417-021-05494-5

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  • DOI: https://doi.org/10.1007/s00417-021-05494-5

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