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Fight Retinal Blindness SPAIN. Report 3: clinical outcomes of vascular endothelial growth factor inhibitors in low vision eyes with neovascular age-related macular degeneration. A national database study

Abstract

Objectives

To compare visual outcomes for low vision eyes (LVE) (<35 letters LogMAR or <20/200 Snellen) versus non-low vision eyes (NLVE) (>35 letters LogMAR or >20/200 Snellen) at the time of the first injection in a clinical practice setting.

Methods

Subgroup analysis of a multicenter national database of treatment- naïve eyes neovascular age related macular degeneration (nAMD) treated with anti-VEGF intravitreal injections divided into LVE and NLVE. Demographics, visual acuity (VA) at baseline and subsequent timepoints (12, 24, and 36 months), number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!).

Results

3138 eyes were included, 705 LVE and 2433 NLVE. The LVE group had the greatest VA gain (p < 0.001), at 12, 24, and 36 months (+15, +15, and +13 letters respectively). The proportion of patients with VA loss (−5 letters) differed between groups at 12, 24, and 36 and was significantly greater (p < 0.001) in NLVE. The proportion of patients with VA gain (+5 letters) was significantly higher (p < 0.001) in LVE in all timeframes. The proportions of LVE that still had VA ≤ 35 letters at 12, 24, and 36 months were 54%, 54%, and 57%. Conversely, 8%, 9%, and 8% of LVE achieved VA ≥ 70 letters at 12, 24, and 36 months. LVE received fewer intravitreal injections than NLVE throughout follow-up (6, 9, 12 vs 7, 11, 15).

Conclusion

Findings of this study support the need for ongoing therapy in patients with initial visual acuity less than 35 letters since sustained visual improvements can be achieved and maintained for the first 3 years of treatment.

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Fig. 1: Visual outcomes at 12 months.
Fig. 2: Visual outcomes at 24 months.
Fig. 3: Visual outcomes at 36 months.

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Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. All data supporting the findings of this study are included in this published article (and its Supplementary Information files).

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Acknowledgements

The authors would like to thank Sonia de Orte Seemann and Cristina Martinez-García from Syneos Health for their invaluable help in the overall management of this study; Sarah Steinmann for the web-based support with the FRB! platform; Guillem Masdeu, Miguel Moratalla, Judith Martinez, Daniel Garcés, Maria Jose Gonzalez and Antonia Soriano from the Fundació Recerca Clínic Barcelona—Institut de Investigacions Biomediques August Pi I Sunyer (FRCB-IDIBAPS) for the administrative support with contracts and legal issues; and Laia Gomez-Baldo and Carmen Navarro from Novartis Spain for the external support during the development of this study.

Funding

This work was supported in part by a grant from Novartis Pharmaceuticals. No member or affiliate of Novartis had any input into data analysis, interpretation of the data, or writing the manuscript.

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Authors

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Contributions

MP, PCP, FBP, and JZV designed the study, conducted the research, and analyzed/interpreted data, MP wrote the manuscript, JZV is the main director and the national coordinator of the FRB! Spain project. PC, FBP, and JZV collected data and edited the manuscript. RMP performed the statistical analysis. MCG is one of the inventors of the software and edited the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Martín Puzo.

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Competing interests

JZV, PCP, and MCG receive funding and consult for Novartis Pharmaceuticals and Bayer. JZV is a member of the Eye editorial board.

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Puzo, M., Calvo-Perez, P., Bartol-Puyal, F. et al. Fight Retinal Blindness SPAIN. Report 3: clinical outcomes of vascular endothelial growth factor inhibitors in low vision eyes with neovascular age-related macular degeneration. A national database study. Eye 38, 3450–3458 (2024). https://doi.org/10.1038/s41433-024-03322-8

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