ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2018
Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02194803 (Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications), which is not on this map. Cited by 31 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.
Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications
Who cites it
31 citing papers in PubMed, 58 citations in OpenAlex.
- Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial.JAMA ophthalmology · 2023Trial
- Intravitreal Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Türkiye: 48-Month Data, BOSPHORUS-DME Study Group Report No. 1.Turkish journal of ophthalmology · 2026Article
- Intravitreal Fluocinolone Acetonide Implant for Diabetic Macular Edema: 2-Year Results from IDEAL, a Prospective German Observational Study.Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde · 2026Observational
- Planned vs. Performed Treatment Regimens in Diabetic Macular Edema: Real-World Evidence from the PACIFIC Study.Journal of clinical medicine · 2025Article
- Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Article
- [Aflibercept in the clinical routine: the AURIGA study : The 24-month results of the German cohort of treatment-naïve patients with diabetic macular edema receiving intravitreal aflibercept].Die Ophthalmologie · 2024Article
- Real-World Experience with Brolucizumab Compared to Aflibercept in Treatment-Naïve and Therapy-Refractory Patients with Diabetic Macular Edema.Journal of clinical medicine · 2024Article
- Sustained Disease Control in DME Patients upon Treatment Cessation with Brolucizumab.Journal of clinical medicine · 2024Article
- Exploring the role of retinal fluid as a biomarker for the management of diabetic macular oedema.Eye (London, England) · 2024Review
- Real-World Outcomes of Intravitreal Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in Türkiye: MARMASIA Study Group Report No. 1.Turkish journal of ophthalmology · 2023Article
- The Psychological, Social and Behavioral Impact of Intravitreal Anti-VEGF Therapy: An Analysis from the ALBATROS Data.Journal of clinical medicine · 2023Article
- See clearer: survey on the subjective and objective information levels as well as perception and information transfer using virtual reality headsets in patients with diabetic macular edema receiving anti-VEGF treatment.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 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
- Ranibizumab or Aflibercept Monotherapies in Treatment-Naive Eyes with Diabetic Macular Edema: A Head-to-Head Comparison in Real-Life Experience.Turkish journal of ophthalmology · 2023Article
- Anti-vascular endothelial growth factor therapy in diabetic macular edema: real-life outcomes from a multicenter study in Turkey over 36 months.International ophthalmology · 2022Article
- Treatment of diabetic macular edema in real-world clinical practice: The effect of aging.Journal of diabetes investigation · 2022Article
- Impact on visual acuity and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY).Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022Observational
- Expression of functional eGFP-fused antigen-binding fragment of ranibizumab inBioImpacts : BI · 2022Article
- Comparison of two-year treatment outcomes between subthreshold micropulse (577 nm) laser and aflibercept for diabetic macular edema.Japanese journal of ophthalmology · 2021Article
- Questionnaire for the assessment of adherence barriers of intravitreal therapy: the ABQ-IVT.International journal of retina and vitreous · 2021Article
Corrections and comments
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Authors and funding
12 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for the treatment of diabetic macular oedema (DME) in a real-world setting in Germany.
methodsAdults with DME receiving ≥ 1 ranibizumab (0.5 mg) injections were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators' routine practice and documented over 24 months.
resultsThe full analysis set included 1226 participants. Mean baseline VA was 60.6 [95% CI: 59.7; 61.5] Early Treatment Diabetic Retinopathy Study letters. VA improved by ≥ 15 letters in 21.5% and 23.5% of the participants at 12 months and 24 months, respectively. They received a mean number of 4.42 [95% CI: 4.30; 4.54] injections in the first year and 5.52 [95% CI: 5.32; 5.73] injections over 24 months, which was markedly lower than in clinical trials. Only 33.4% of the participants received an upload with four initial monthly injections as recommended by the German ophthalmologic societies. Time-to-event analyses that account for missing data inherent to a non-interventional study design demonstrated that participants receiving ≥ 7 injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1-3 and 4-6 injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population.
conclusionUnder-treatment is a major problem of DME anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer injections given compared to randomised controlled trials with a consequently reduced overall mean visual gain, a profound functional improvement (≥ 15 letters) was achieved over 2 years in 23.5% of eyes with DME. TRIAL REGISTRATION NUMBER: NCT02194803, ClinicalTrials.gov.
fundingNovartis Pharma GmbH, Nuremberg, Germany.
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