Trial reportAdvances in therapy2022
Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.
Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02818998 (An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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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.
An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of Aflibercept 8 mg for the Treatment of Diabetic Macular Edema in Italy: A Cost-Minimisation Analysis Based on an Indirect Treatment Comparison.Advances in therapy · 2026Pooled it
- Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing.Advances in therapy · 2024Trial
- Pharmacological principles of intravitreal drug therapy and their implications for clinical practice: a primer for the ophthalmologist.Eye (London, England) · 2026Review
- Twelve-Month Outcomes Using Aflibercept 8 mg in Treatment-Naïve and Pretreated Diabetic Macular Edema: A Swiss Retina Research Network Report.Ophthalmology science · 2026Article
- Efficacy of conbercept pro re nata (PRN) versus treat-and-extend (T&E) regimens following five initial monthly doses in diabetic macular edema: a 24-month retrospective cohort study.Frontiers in endocrinology · 2026Article
- Economic Assessment in Resource-Constrained Systems: Individual-Level Simulation Model in Wet Age-Related Macular Degeneration and Diabetic Macular Oedema.Ophthalmology and therapy · 2024Article
- Machine learning and optical coherence tomography-derived radiomics analysis to predict persistent diabetic macular edema in patients undergoing anti-VEGF intravitreal therapy.Journal of translational medicine · 2024Article
- Sustained Disease Control in DME Patients upon Treatment Cessation with Brolucizumab.Journal of clinical medicine · 2024Article
- Functional Outcomes of Brolucizumab-Induced Intraocular Inflammation Involving the Posterior Segment-A Meta-Analysis and Systematic Review.Journal of clinical medicine · 2023Review
- Clinical Application of Intravitreal Aflibercept Injection for Diabetic Macular Edema Comparing Two Loading Regimens.Medicina (Kaunas, Lithuania) · 2023Article
- Evaluating the Treatment of Diabetic Macular Edema with Aflibercept Based on a Regional Network of Ophthalmologic Care Givers.Journal of ophthalmology · 2023Article
- Treatment Cessation in Patients with Diabetic Maculopathy under Intravitreal Anti-VEGF Therapy Following a Treat-and-Extend Protocol.Ophthalmology scienceArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for ≥ 1 year according to the European label.
methodsPatients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52.
resultsFull analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min-max) of 10.0 (2-14; T&E), 11.5 (1-25; PRN), and 12.3 (3-13; fixed) injections over 100 weeks, with 13.3 (4-23), 25.0 (3-29), and 16.1 (5-25) clinic visits, respectively. At Week 52, mean (± standard deviation) BCVA changes from baseline were + 0.5 ± 6.7 (T&E), + 1.7 ± 6.8 (PRN), and + 0.4 ± 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [- 1.46, 1.47] and PRN 0.95 (- 0.52, 2.42) letters versus fixed dosing; p < 0.0001 for both non-inferiority tests [4-letter margin]). The IVT-AFL safety profile was consistent with previous studies.
conclusionThe treatment burden associated with intravitreal injections for DME is lowest with T&E regimens, but there are a range of flexible IVT-AFL dosing regimens, allowing physicians to adopt an individualized treatment plan.
trial registrationClinicalTrials.gov identifier: NCT02818998.
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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 OpenQuestion graph.