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Peer-reviewedCC BY-NCOphthalmology and Therapy

Early Intraretinal Fluid Reduction is Linked to Vision Gains in Patients with Diabetic Macular Edema

  • Yiyi Wang1
  • Derrek P. Hibar1
  • Srinivas Sadda2
  • Jennifer I. Lim3
  • Clement K. Chan4
  • Gavin S. Tan5
  • Katherine E. Talcott6
  • Kara Gibson7
  • Andreas Maunz8
  • Huanxiang Lu8
  • Thomas Albrecht8
  • Manuel Amador1
1 more authors
  • Katie M. Litts1
8 affiliations
  1. 1Genentech, Inc.
  2. 2Doheny Eye Institute
  3. 3University of Illinois at Chicago
  4. 4Desert Retina Consultants
  5. 5Singapore National Eye Centre
  6. 6Cleveland Clinic
  7. 7Roche Products Ltd.
  8. 8F. Hoffmann-La Roche Ltd.
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Abstract

Introduction This analysis evaluated the impact of early intraretinal fluid (IRF) reduction on long-term visual outcomes in patients with diabetic macular edema (DME). Methods This was a treatment-agnostic, post hoc analysis of pooled data from patients with DME in YOSEMITE/RHINE (NCT03622580/NCT03622593). The relationship between IRF volume changes (evaluated using deep learning-based retinal optical coherence tomography segmentation algorithm [ROSA]) after 3-monthly injections and anatomical/visual outcomes at 2 years was assessed. Patients were categorized by proportional IRF volume reduction from baseline at month 3: < 20% (group 1), 20–50% (group 2), > 50% (group 3). Comparisons were made across groups, including changes from baseline in ROSA-derived fluid volume and best-corrected visual acuity (BCVA). A complementary analysis was performed based on IRF volume reduction at 1-month and 1-year outcomes. Results The main analysis included eyes from 795 patients: 259 (32.6%) treated with faricimab 6 mg every 8 weeks (Q8W), 279 (35.1%) treated with faricimab 6 mg treat-and-extend, and 257 (32.3%) treated with aflibercept 2 mg Q8W. In groups 1–3, mean IRF volume decreases from baseline at year 2 were 236, 282, and 312 nL (nominal p < 0.05 for groups 2 and 3 vs. 1), respectively. Corresponding subretinal fluid volume decreases were 37, 48, and 41 nL, respectively. In groups 1–3, adjusted mean BCVA increases from baseline at year 2 were 7.9, 10.3, and 12.2 letters (nominal p = 0.0005 for group 1 vs. 3), respectively, with 23%, 36%, and 41% of patients (nominal p = 0.0015 for group 1 vs. 3), respectively, gaining ≥ 15 letters. Similar results were observed in the complementary analysis. Conclusion Greater IRF volume reduction during the first 3 months of treatment was associated with improved long-term outcomes in DME. These data may inform discussions between physicians and their patients when discussing long-term anatomic/functional outcomes of treatment. Trial Registration ClinicalTrials.gov identifier: NCT03622580/NCT03622593 (YOSEMITE/RHINE).

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Cite

BibTeXRIS
BibTeX
@article{wang2026early,
  title = {{Early Intraretinal Fluid Reduction is Linked to Vision Gains in Patients with Diabetic Macular Edema}},
  author = {Yiyi Wang and Derrek P. Hibar and Srinivas Sadda and Jennifer I. Lim and Clement K. Chan and Gavin S. Tan and Katherine E. Talcott and Kara Gibson and Andreas Maunz and Huanxiang Lu and Thomas Albrecht and Manuel Amador and Katie M. Litts},
  journal = {Ophthalmology and Therapy},
  year = {2026},
  month = sep,
  doi = {10.1007/s40123-026-01504-z},
  url = {https://doi.org/10.1007/s40123-026-01504-z},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - Early Intraretinal Fluid Reduction is Linked to Vision Gains in Patients with Diabetic Macular Edema
AU  - Yiyi Wang
AU  - Derrek P. Hibar
AU  - Srinivas Sadda
AU  - Jennifer I. Lim
AU  - Clement K. Chan
AU  - Gavin S. Tan
AU  - Katherine E. Talcott
AU  - Kara Gibson
AU  - Andreas Maunz
AU  - Huanxiang Lu
AU  - Thomas Albrecht
AU  - Manuel Amador
AU  - Katie M. Litts
PY  - 2026
DA  - 2026/09/01
JO  - Ophthalmology and Therapy
DO  - 10.1007/s40123-026-01504-z
UR  - https://doi.org/10.1007/s40123-026-01504-z
AB  - Introduction This analysis evaluated the impact of early intraretinal fluid (IRF) reduction on long-term visual outcomes in patients with diabetic macular edema (DME). Methods This was a treatment-agnostic, post hoc analysis of pooled data from patients with DME in YOSEMITE/RHINE (NCT03622580/NCT03622593). The relationship between IRF volume changes (evaluated using deep learning-based retinal optical coherence tomography segmentation algorithm [ROSA]) after 3-monthly injections and anatomical/visual outcomes at 2 years was assessed. Patients were categorized by proportional IRF volume reduction from baseline at month 3: < 20% (group 1), 20–50% (group 2), > 50% (group 3). Comparisons were made across groups, including changes from baseline in ROSA-derived fluid volume and best-corrected visual acuity (BCVA). A complementary analysis was performed based on IRF volume reduction at 1-month and 1-year outcomes. Results The main analysis included eyes from 795 patients: 259 (32.6%) treated with faricimab 6 mg every 8 weeks (Q8W), 279 (35.1%) treated with faricimab 6 mg treat-and-extend, and 257 (32.3%) treated with aflibercept 2 mg Q8W. In groups 1–3, mean IRF volume decreases from baseline at year 2 were 236, 282, and 312 nL (nominal p < 0.05 for groups 2 and 3 vs. 1), respectively. Corresponding subretinal fluid volume decreases were 37, 48, and 41 nL, respectively. In groups 1–3, adjusted mean BCVA increases from baseline at year 2 were 7.9, 10.3, and 12.2 letters (nominal p = 0.0005 for group 1 vs. 3), respectively, with 23%, 36%, and 41% of patients (nominal p = 0.0015 for group 1 vs. 3), respectively, gaining ≥ 15 letters. Similar results were observed in the complementary analysis. Conclusion Greater IRF volume reduction during the first 3 months of treatment was associated with improved long-term outcomes in DME. These data may inform discussions between physicians and their patients when discussing long-term anatomic/functional outcomes of treatment. Trial Registration ClinicalTrials.gov identifier: NCT03622580/NCT03622593 (YOSEMITE/RHINE).
SN  - 2193-8245
SN  - 2193-6528
ER  -