ArticleOphthalmology science2023
BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale.
Article in Ophthalmology science, 2023. 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. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Faricimab: current evidence for the treatment of retinal vein occlusion.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Pooled it
- Systematic review of clinical practice guidelines for the diagnosis and management of retinal vein occlusion.Eye (London, England) · 2024Pooled it
- [Pioneering trials in ophthalmology-From clinical trials to guideline treatment].Die Ophthalmologie · 2026Article
- Early Macular Leakage Resolution Is Associated with Extended Faricimab Dosing in Retinal Vein Occlusion: A BALATON/COMINO Post Hoc Analysis.Ophthalmology and therapy · 2026Article
- Adoption patterns of anti-vascular endothelial growth factor therapies in retinal disease.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026Article
- Early Real-World Experience of Switching to Faricimab for Macular Oedema Secondary to Vein Occlusion.Life (Basel, Switzerland) · 2026Article
- SD-OCT-based biomarkers in predicting treatment outcomes of macular oedema secondary to retinal vein occlusion treated with anti-VEGF therapy.Acta ophthalmologica · 2026Article
- Treatment patterns and long-term outcomes in anti-VEGF-treated macular oedema secondary to retinal vein occlusion: a retrospective observational study.Eye (London, England) · 2026Observational
- Efficacy of faricimab for recalcitrant multifactorial cystoid macular edema.American journal of ophthalmology case reports · 2025Article
- Real-life short-term experience of switching from other anti-VEGF therapy to faricimab in patients with refractory macular edema secondary to retinal vein occlusion in China.International ophthalmology · 2025Article
- Extended Real-World Efficacy of Faricimab in Therapy-Resistant Macular Edema Due to Retinal Vein Occlusion: 9-Month Follow-Up Results.Journal of clinical medicine · 2025Article
- Short-term real-world effectiveness of faricimab on macular edema due to retinal vein occlusion.International journal of retina and vitreous · 2025Article
- Emerging clinical evidence of a dual role for Ang-2 and VEGF-A blockade with faricimab in retinal diseases.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Review
- Switching to Faricimab in Therapy-Resistant Macular Edema Due to Retinal Vein Occlusion: Initial Real-World Efficacy Outcomes.Journal of clinical medicine · 2025Article
- Faricimab maintains substance integrity and sterility after compounding and storage in two different polypropylene syringe types.Eye (London, England) · 2025Article
- Faricimab for retinal vein occlusion: a review of current evidence and future perspectives.Frontiers in pharmacology · 2025Review
- Anti-vascular endothelial growth factor therapies in ophthalmology.Medical hypothesis, discovery & innovation ophthalmology journal · 2025Review
- Article
- Integrated Assessment of OCT, Multimodal Imaging, and Cytokine Markers for Predicting Treatment Responses in Retinal Vein Occlusion Associated Macular Edema: A Comparative Review of Anti-VEGF and Steroid Therapies.Diagnostics (Basel, Switzerland) · 2024Review
- Infographic: study design of the BALATON and COMINO phase 3 randomised trials of faricimab in patients with retinal vein occlusion.Eye (London, England) · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO). Design: Two identically designed global, randomized, double-masked, active comparator-controlled studies. Participants: Anti-VEGF treatment-naive patients with branch, central, or hemiretinal RVO. Methods: Patients were randomized to 6 monthly injections of faricimab 6.0 mg or aflibercept 2.0 mg. From weeks 24 to 72, all patients received faricimab 6.0 mg administered in up to 16-week intervals using an automated treatment algorithm to generate a treat-and-extend-based personalized treatment interval dosing regimen. Personalized treatment interval adjustments were based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA). Main Outcome Measures: Primary end point was noninferiority of faricimab versus aflibercept in mean change from baseline in BCVA (week 24; noninferiority margin: 4 letters). Secondary end points (weeks 0-24) were mean change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire 25 composite score; proportion of patients gaining or avoiding loss of ≥ 15/≥ 10/≥ 5/> 0 letters. Secondary end points (weeks 24-72) were treatment durability (week 68); continuation of weeks 0 to 24 end points. Ocular/nonocular adverse events will be assessed. Results: In total, 1282 patients across 22 countries were enrolled (BALATON, 553 patients, 149 centers; COMINO, 729 patients, 193 centers). Conclusions: Using a novel automated interval algorithm, BALATON/COMINO will evaluate the efficacy and safety of faricimab for ME secondary to RVO and provide key insights into how to personalize treatment. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.