ArticleOphthalmology and therapy2026
Early Intraretinal Fluid Reduction is Linked to Vision Gains in Patients with Diabetic Macular Edema.
Article in Ophthalmology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
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13 authors.
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Abstract
introductionThis analysis evaluated the impact of early intraretinal fluid (IRF) reduction on long-term visual outcomes in patients with diabetic macular edema (DME).
methodsThis 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.
resultsThe 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.
conclusionGreater 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 registrationClinicalTrials.gov identifier: NCT03622580/NCT03622593 (YOSEMITE/RHINE).
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