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Factors associated with achieving various visual acuity outcomes during loading doses of aflibercept 2 mg for treatment naïve exudative age-related macular degeneration: PRECISE Study Report 7

Eye volume 39, pages 1553–1561 (2025) Cite this article

Subjects

Abstract

Purpose

To identify demographic and baseline OCT characteristics that are predictive of VA outcomes after the first and post-loading injections in patients treated with 2 mg aflibercept.

Methods

This study evaluated VA outcomes in 1999 eyes of 1862 patients with nAMD initiated on aflibercept therapy. Demographic and OCT (Spectralis, Heidelberg Engineering) features associated with good VA outcome defined as VA ≥ 68 ETDRS letters (Snellen ≥  6/12) and poor VA outcome of <54 ETDRS letters (Snellen < 6/18) or a loss of ≥5 ETDRS letters after first and post-loading injections were analysed using logistic regression via generalised estimating equations.

Results

The mean age was 79.3 (SD 7.8) years, 1126 (60.5%) were females, and predominantly white ethnic background (1772 [95.2%]). The mean presenting VA was 58.0 (SD 14.5) ETDRS letters. After the loading phase, 930/1994 (46.6%) eyes achieved VA ≥ 68 ETDRS letters, and 457 (22.9%) attained VA < 54 ETDRS letters. Increasing age, non-white ethnicity, and baseline VA < 54 letter score is associated with VA < 54 letters. The OCT parameters associated with reduced odds of VA ≥ 68 ETDRS letters and increased odds of VA < 54 ETDRS letters after first and post-loading phase included fovea-involving intraretinal fluid, all types of macular neovascularisation (MNV) versus type 1 MNV, fovea-involving MNV (vs. non-foveal MNV), subfoveal MNV complex, increased central subfield thickness, foveal presence of subretinal hyper-reflective material, atrophy, fibrosis, ungradable or ellipsoid zone and/or external limiting membrane loss.

Conclusion

This study could provide individual-level visual prognosis about their post-loading VA based on demography, VA and OCT characteristics at presentation.

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Fig. 1: VA outcomes across at baseline, V2 and V4.
The alternative text for this image may have been generated using AI.
Fig. 2: OCT characteristics associated with VA ≥ 68 ETDRS letters for visit 2 (post single injection) and visit 4 (post loading phase).
The alternative text for this image may have been generated using AI.
Fig. 3: OCT characteristics associated with VA < 54 ETDRS letters at visit 2 (post single injection) and visit 4 (post loading phase).
The alternative text for this image may have been generated using AI.
Fig. 4: OCT characteristics associated with VA ≥ 5 letter loss at visit 2 (post single injection) and visit 4 (post loading phase).
The alternative text for this image may have been generated using AI.

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Data availability

The anonymised PRECISE clinical database analysed during the current study is available from author SS on approval of a data sharing agreement with Moorfields Eye Hospital. Sharing of retinal images requires patient consent and sponsor approval.

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Funding

The investigator-initiated study was funded by Boehringer Ingelheim International GmbH (Grant number: SIVS1045). This study was also supported by the NIHR Biomedical Research Centre and Clinical Research Facility at the Moorfields Eye Hospital National Health Service Foundation Trust and the University College London Institute of Ophthalmology. Boehringer Ingelheim was involved in the review and approval of the manuscript.

Author information

Authors and Affiliations

  1. National Institute of Health Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, UK

    Swati Chandak, Sarega Gurudas, Raheeba Mohammed Pakeer, Dimitrios Kazantzis & Sobha Sivaprasad

  2. Institute of Ophthalmology, University College, London, UK

    Sarega Gurudas & Sobha Sivaprasad

  3. Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK

    Faruque Ghanchi

  4. King’s College Hospital NHS Foundation Trust, London, UK

    Anna Grabowska

  5. Newcastle Hospitals NHS Foundation Trust, Newcastle, UK

    Stephen James Talks

  6. The Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust, Liverpool, UK

    Ian Pearce

  7. Leeds Teaching Hospitals NHS Trust, Leeds, UK

    Martin McKibbin

  8. South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK

    Ajay Kotagiri

  9. Frimley Health NHS Foundation Trust, Surrey, UK

    Geeta Menon

  10. James Paget University Hospitals NHS Foundation Trust, Norfolk, UK

    Benjamin JL Burton

  11. York Teaching Hospital NHS Foundation Trust, York, UK

    Richard Gale

Authors
  1. Swati Chandak
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  2. Sarega Gurudas
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  3. Raheeba Mohammed Pakeer
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  4. Dimitrios Kazantzis
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  8. Ian Pearce
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  13. Richard Gale
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  14. Sobha Sivaprasad
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Contributions

Conceptualization: SS; Data curation: DK, ST, RMP and SC; Formal analysis: SG and SS; Funding acquisition: SS; Investigation: SC, SG and SS; Methodology: SC, SG and SS Project administration: SS; Resources: GM, BJB, IP, MM, SC, RPM, AM, AK, JT, FG, RG and SS; Supervision: SS; Visualization: SG and SC; Writing—original draft: SC, SG and SS; Writing—review & editing: SC, SG and SS Review and approval of final manuscript: SC, SG, DK, SS, GM, BJB, IP, MM, RPM, AK, JT, AG, FG and RG.

Corresponding author

Correspondence to Sobha Sivaprasad.

Ethics declarations

Competing interests

Sivaprasad reported receiving financial support from AbbVie, Alimera Science, Amgen, Apellis, Astellas, Bayer, Biogen, Boehringer Ingelheim, Clearside Biomedical, Eyebiotech, Eyepoint Phamaceuticals, Iveric Bio, Janssen Pharmaceuticals, Nova Nordisk, Optos, Ocular Therapeutix, Kriya Therapeutics, OcuTerra, Ripple Therapeutics, Roche, Stealth Biotherapeutics and Sanofi. Sobha Sivaprasad is the Editor-in-Chief of EYE. Faruque Ghanchi has received honorarium for consultancy-advisory boards from Alimera, Allergan, Bayer, Novartis, Oxford BioElectronics, Roche; educational travel grants from Allergan, Bayer, Novartis. James Talks is a consultant for Bayer and Roche, received grant support from Bayer, Roche, and Heidelberg Engineering, and is involved in research for, Roche, Bayer, Janssen Pharmaceutical,s and Boehringer-Ingelheim. Ian Pearce - IP has received lecture fees from Allergan, Bayer, Heidelberg, and Novartis, consultancy fees from Allergan, Alimera, Bayer, and Novartis and travel fees from Allergan, Bayer, and Novartis; Martin McKibbin has received lecture and advisory board honoraria from Bayer and Novartis and an educational travel grant from Bayer; Ajay Kotagiri received travel support from Novartis, Bayer, and Allergan, and speaker fees from Allergan and Bayer; Geeta Menon has conducted consultancy-advisory boards for Novartis, Bayer and Allergan, received educational travel grants from Novartis, Bayer, Allergan; Benjamin Burton is in the advisory board and received international conference attendance sponsored by Novartis and Bayer; Richard Gale has conducted consultancy-advisory boards for Novartis, Bayer and Allergan, Alimera, Santen, received educational travel grants from Novartis, Bayer, Allergan, Heidelberg Engineering. The remaining author declares no competing interests.

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Chandak, S., Gurudas, S., Pakeer, R.M. et al. Factors associated with achieving various visual acuity outcomes during loading doses of aflibercept 2 mg for treatment naïve exudative age-related macular degeneration: PRECISE Study Report 7. Eye 39, 1553–1561 (2025). https://doi.org/10.1038/s41433-025-03687-4

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