ArticleInternational journal of retina and vitreous2016
Initiation of intravitreal aflibercept injection treatment in patients with diabetic macular edema: a review of VIVID-DME and VISTA-DME data.
Article in International journal of retina and vitreous, 2016. 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.
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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.
A Randomized, Double Masked, Active Controlled, Phase III Study of the Efficacy and Safety of Repeated Doses of Intravitreal VEGF Trap-Eye in Subjects With Diabetic Macular Edema
A Double-Masked, Randomized, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema
Who cites it
21 citing papers in PubMed, 44 citations in OpenAlex.
- Three versus five intravitreal aflibercept injections as the initial loading phase in the treatment of diabetic macular edema: one-year results.Arquivos brasileiros de oftalmologiaTrial
- Planned vs. Performed Treatment Regimens in Diabetic Macular Edema: Real-World Evidence from the PACIFIC Study.Journal of clinical medicine · 2025Article
- How intravitreal anti-vascular endothelial growth factor initial dosing impacts patient outcomes in diabetic macular oedema.BMC ophthalmology · 2024Article
- Short-Term Clinical Outcomes of Patients with Diabetic Macular Edema Following a Therapy Switch to Faricimab.Journal of clinical medicine · 2024Article
- Modified early intensive and treat-and-extend regimen of anti-vascular endothelial growth factor for diabetic macular edema in Taiwan.Scientific reports · 2023Article
- Real-World Outcomes of Anti-VEGF Therapy in Diabetic Macular Oedema: Barriers to Treatment Success and Implications for Low/Lower-Middle-Income Countries.Ophthalmology and therapy · 2023Review
- Factors Affecting Intensive Aflibercept Treatment Response in Diabetic Macular Edema: A Real-World Study.Journal of diabetes research · 2023Article
- Efficacy and safety of intravitreal anti-VEGF therapy in diabetic retinopathy: what we have learned and what should we learn further?Expert opinion on biological therapy · 2022Review
- Hypertensive cerebral hemorrhage with undetectable plasma vascular endothelial growth factor levels in a patient receiving intravitreal injection of aflibercept for bilateral diabetic macular edema: a case report.Journal of medical case reports · 2021Article
- Indicators of Visual Prognosis in Diabetic Macular Oedema.Journal of personalized medicine · 2021Review
- Statement of the German Ophthalmological Society, the German Retina Society, and the Professional Association of Ophthalmologists in Germany on treatment of diabetic macular edema : Dated August 2019.Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2021Review
- Aflibercept for treatment-naïve diabetic macula oedema in a multi-ethnic population: Real-world outcomes from North West London.PloS one · 2021Article
- Real-world outcomes following 12 months of intravitreal aflibercept monotherapy in patients with diabetic macular edema in France: results from the APOLLON study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2020Observational
- [Statement of the German Ophthalmological Society, the Retinological Society and the Professional Association of Ophthalmologists in Germany on treatment of diabetic macular edema : Situation August 2019].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2020Review
- Identifying Genetic Risk Factors for Diabetic Macular Edema and the Response to Treatment.Journal of diabetes research · 2020Review
- [Treatment reality with ranibizumab in clinical routine use for patients with diabetic macular edema : 1‑year results of the German POLARIS cohort].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2019Article
- Diabetic macular edema treated with intravitreal aflibercept injection after treatment with other anti-VEGF agents (SWAP-TWO study): 6-month interim analysis.International journal of retina and vitreous · 2019Article
- Evaluation of ranibizumab and aflibercept for the treatment of diabetic macular edema in daily clinical practice.PloS one · 2019Observational
- Identification of time point to best define 'sub-optimal response' following intravitreal ranibizumab therapy for diabetic macular edema based on real-life data.Eye (London, England) · 2017Observational
- Association Between First- and Third-Month Responses to Intravitreal Ranibizumab for Diabetic Macular Edema.Journal of vitreoretinal diseasesArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetic macular edema (DME) shows a gradual and sustained functional and morphologic response to anti-vascular endothelial growth factor (VEGF) drugs, but the optimal schedule for initiation of anti-VEGF therapy is not known. This study evaluates the treatment response behavior of DME in the Phase 3 trials of intravitreal aflibercept, with 5 initial intravitreal aflibercept injections (IAI), 2 mg every 4 weeks (2q4), in the upload phase.
methodsThis post hoc pooled analysis of the VISTA-DME (NCT01363440) and VIVID-DME (NCT01331681) trials evaluated the change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) during the upload phase, using pooled data from both IAI treatment groups [2q4 and 2 mg every 8 weeks (2q8)]. The mean visit-to-visit change in BCVA and CRT, and the respective rate of gainers and losers was calculated for each successive visit. A secondary analysis compared the visit-to-visit change in BCVA between the 2q4 and 2q8 treatment arms during the upload period and the first year treatment period.
resultsThe majority of eyes showed a continuing improvement of BCVA after the first IAI. The proportions of eyes gaining BCVA (≥5 letters) at each visit compared with the previous visit during the IAI 2q4 upload phase were 60 (4-weeks), 19 (8-weeks), 16 (12-weeks), 15 (16-weeks), and 14 % (20-weeks). In contrast, the proportions of eyes losing BCVA (≥5 letters) were 3 (4-weeks), 7 (8-weeks), 7 (12-weeks), 9 (16-weeks), and 8 % (20-weeks), respectively. The odds of BCVA (≥5 letters) gain/loss exceeded 1.7 at each visit (range 1.7-20). Overall, the proportion of patients with BCVA gain ≥5 letters at week 20 (compared with baseline) was 76 and 80 % in the 2q4 and 2q8 groups, respectively. The proportions of eyes showing a visit-to-visit decrease in CRT of ≥30 µm during the first 5 IAI were 77 (4-weeks), 27 (8-weeks), 21 (12-weeks), 17 (16-weeks), and 12 % (20-weeks). In the secondary analysis, the BCVA outcomes were similar for the 2q8 and 2q4 treatment arms.
conclusionsThe data presented here are consistent with continual functional and anatomic improvement following the fourth and fifth initial 2q4 injections, suggesting that an intensive and sufficiently long upload may be beneficial.
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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.