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Purpose: As part of the prospective, non-interventional OCEAN study, the ORCA module evaluated physicians' spectral domain optical coherence tomography (SD-OCT) image interpretations in the treatment of diabetic macular oedema (DME) or macular oedema (ME) secondary to retinal vein occlusion (RVO)., Methods: Presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) was evaluated independently by physicians and reading centres (RCs) on 1612 SD-OCT scans of 133 patients diagnosed with either DME or ME secondary to RVO. Agreement between physicians and RCs was calculated for both cohorts individually and as a combined ME cohort. Physicians' treatment decisions were analysed related to the results of the OCT-evaluations., Results: For the combined ME cohort, presence of IRF/SRF was recorded by RCs in 792/1612 (49.1%) visits and by physicians in 852/1612 (52.9%) visits, with an agreement regarding presence or absence of foveal fluid in 70.4% of cases. In 64.4% (510/792) of visits with RC-detected foveal IRF and/or SRF no injection was given. In 30.3% of these visits with foveal fluid no reason was identified for a 'watch and wait' approach indicating possible undertreatment. BCVA deterioration was seen in a quarter of these eyes at the following visit., Conclusion: Despite good agreement between physicians and RCs to recognize SRF and IRF, our data indicate that omitting injections despite foveal involvement of fluid is frequent in routine clinical practice. This may put patients at risk of undertreatment, which may negatively impact real-life BCVA outcomes., Trial Registration: www., Clinicaltrials: gov , identifier NCT02194803., Competing Interests: Declarations. Ethical approval: The OCEAN study was approved by the ethics committee of the Eberhard-Karls-University, Tuebingen, Germany. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Separate informed consent was required for patients to be included in the ORCA module. Consent to participate: Every patient was informed by the treating physician about the key objectives as well as the type and scope of the documentation. Eligible patients could only be included in the study after providing written informed consent, or, if incapable of doing so, after such consent had been provided by a legally acceptable representative of the patient. Consent for publication: Patients signed informed consent regarding publishing their data. Conflicts of interests: Georg Spital received personal fees from Bayer Healthcare, Novartis, Roche, OD-OS, and Allergan Pharma and grants from Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope, Alexion. Steffen Schmitz-Valckenberg received contracts and personal fees for consultancy from Novartis as part of the submitted work. Outside the submitted work, he received grants or contracts from AlphaRET, Apellis, Bayer, Bioeq/Formycon, Carl Zeiss MediTec, Katairo, Kubota Vision, Novartis, Pixium, Roche/Genentech, SparingVision; Consulting fees from Apellis, Bioeq/Formycon, Galimedix, Novartis, Oxurion, Roche/Genentech; and nonfinancial support from Carl Zeiss Meditec and Heidelberg Engineering, outside the submitted work; being co-founder of the STZ GRADE Reading Centre. Bettina Müller and Erika Liczenczias are employees of Novartis. Petrus Chang received grants from Heidelberg Engineering, Novartis, ZeissMeditec. Britta Heimes-Bussmann received grants Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope and personal fees von Bayer. Focke Ziemssen received research grants from Bayer, BMBF, Clearside, DFG, Kodiak, Iveric, Ophtea, Novartis, Regeneron, consulting fees from Alimera Sciences, Allergan/Abbvie, Bayer, Boehringer-Ingelheim, Novartis, NovoNordisk, MSD, Oxurion, Roche/Genentech, and fees as speaker from Alimera, Allergan/Abbvie, Bayer, BDI, CME Health, Gerling, Novartis, ODOS, Roche. Sandra Liakopoulos received grants from Novartis, personal fees from Novartis, Heidelberg Engineering, Carl Zeiss Meditec, Allergan/Abbvie, Bayer, Apellis, and consulting fees from Novartis, Bayer, Apellis and Allergan., (© 2024. The Author(s).)

Diabetic retinopathy (DR) is one of the most common complications of diabetes mellitus and one of the leading causes of visual impairment in working age individuals in the western world. The treatment of DR depends on its severity, so it is of great importance to detect patients as early as possible, in order to initiate early treatment and preserve vision. Despite currently insufficient screening participation, patients with diabetes already visit ophthalmological practices and clinics above average. Their medical care, including DR diagnostics and treatment has been making up an increasing proportion of ophthalmic activity for years. Since the prevalence of diabetes is increasing dramatically worldwide and a further increase is also predicted for Germany, the challenge for ophthalmologists is likely to grow considerably. As the same time, the diagnostic possibilities for differentiating DR and the therapeutic measures, especially with IVOM therapy, are becoming more and more complex, which increases the time burden in everyday clinical practice. The hope to avoid healthcare deficits and to further improve screening rates and visual acuity prognosis in patients with DR is based, among other things, on camera-assisted screening supported by artificial intelligence. Better diabetes management to reduce the prevalence of DR, as well as longer-acting drugs to treat DR, could also improve the care and help reduce the burden on ophthalmology practices., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht./The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: An increasing number of patients suffering from diabetes require regular ophthalmological check-ups to diagnose and/or treat potential diabetic retinal disease. Some countries have already implemented systematic fundus assessments including artificial intelligence-based programs in order to detect sight-threatening retinopathy. The aim of this study was to improve the detection of diabetic fundus changes in Germany without examination by a doctor and to create an easy access to ophthalmological examinations., Material and Methods: In this prospective monocentric study 93 patients in need for a routine check-up for diabetic retinopathy were included. The study participants took up an offer of an examination (visual examination, non-mydriatic camera-based fundus examination) without doctor-patient contact. Patient satisfaction with the organization and examinations was assessed using a questionnaire., Results: The mean age was 53.5 years (SD 13.6 years, 49.5% female) and 17 eyes (18.3%) showed a diabetic retinopathy which was detected using a camera-based examination. Within the small sample, no patient had to repeat the examination due to poor image quality. All categories of the questionnaire showed a good to very good satisfaction, indicating a high acceptance of the other examination form that took place at the ophthalmologist's premises., Conclusion: In our study in an ophthalmological practice a high level of acceptance among the patients interested in the screening for diabetic retinopathy without any direct patient-doctor contact was achieved. Our study shows a very good acceptance and feasibility. Future use of artificial intelligence in clinical practice may help to be able to screen many more patients as in this study imaging quality was very good., (© 2022. The Author(s).)

Purpose: Ranibizumab monotherapy showed stronger effects on area of retinal neovascularization (NV) reduction while offering better visual acuity (VA) results than panretinal laser photocoagulation (PRP) monotherapy during the first 12 months of the PRIDE study. The second year of PRIDE was an observational, non-interventional follow-up, performed to evaluate long-term anatomical and functional outcomes in proliferative diabetic retinopathy (PDR) patients under real-life conditions, prior to the approval of ranibizumab for PDR., Methods: Seventy-three PDR patients (28 from the ranibizumab group; 20 from the PRP group; 25 from the combination group) were included in the observational follow-up phase and treated at the investigators discretion. Visual acuity (VA) measurements and retinal imaging were performed at Months 12, 18 and 24., Results: Mean (± SD) NV area in the ranibizumab monotherapy and combination follow-up groups increased from 3.16 ± 4.30 mm 2 and 1.13 ± 2.78 mm 2 at Month 12 to 6.09 ± 10.79 mm 2 and 2.14 ± 4.41 mm 2 at Month 18 and 10.00 ± 17.63 mm 2 and 3.26 ± 7.05 mm 2 at Month 24, respectively. In the PRP follow-up group, NV area declined from 5.44 ± 14.55 mm 2 at Month 12 to 1.22 ± 1.67 mm 2 at Month 18, but increased again to 4.05 ± 11.66 mm 2 at Month 24. During the observational phase, only 2 (6;8) patients in the ranibizumab (PRP;combination) follow-up group were treated with anti-VEGF medications, while 17 (6;10) patients received PRP laser therapy., Conclusion: Discontinuation of ranibizumab treatment in PDR patients may result in an increase of NV area and VA loss. Tight monitoring of disease activity and continued treatment beyond the first year is needed to maintain disease control., (© 2021 Novartis Pharma GmbH. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: To assess efficacy and safety of intravitreal ranibizumab 0.5 mg plus laser (COMBI) versus laser monotherapy (LASER) in patients with visual impairment due to diabetic macular oedema (DME) in either nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) and to analyse the relevance of inner versus outer retinal thickness., Methods: In this double-masked, multicentre phase IIIb study, patients (N = 128) were randomized (2:1) to receive COMBI (n = 85) versus LASER (n = 43). Patients received four initial monthly injections of ranibizumab 0.5 mg (COMBI) or sham (LASER) followed by pro re nata (PRN) injections. In both groups, patients received laser at baseline and additional laser at 3 monthly intervals, as needed. The study was started in 2010 and was prematurely terminated due to approval of ranibizumab for DME., Results: The least squares (LS) mean change in mean best-corrected visual acuity (BCVA) from baseline to month 12 was higher in the COMBI (6.5) versus LASER (2.3) group (LS mean difference: 4.2 [95% CI 0.9; 7.4] letters, p = 0.01, primary end-point). There was also a tendency in the same direction for the subgroup of 26 patients with PDR (LS mean difference 14.7, p = 0.11). Mean central retinal thickness decreased by 107.3 μm in the COMBI group and by 80.3 μm in the LASER group from baseline to month 12 (p = 0.28). Ranibizumab was well tolerated., Conclusion: This study showed that ranibizumab plus laser is a valuable treatment option for the management of DME. Patients with DME in PDR might also benefit from combined therapy compared to laser alone., (© 2017 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

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Purpose: Panretinal photocoagulation (PRP) is the current standard of care in proliferative diabetic retinopathy (PDR). However, treatment with anti‐vascular endothelial growth factor agents might offer better patient outcomes with fewer side‐effects. The PRIDE study aimed to assess the efficacy and safety of ranibizumab with or without PRP compared with PRP alone in patients with PDR. Methods: A total of 106 PDR patients without diabetic macular oedema were randomized to receive ranibizumab 0.5 mg monotherapy (n = 35), PRP (n = 35) or combined ranibizumab 0.5 mg/PRP (n = 36). The primary objective of this 12‐month, multicentre, phase II study was to investigate the change in area of retinal neovascularization (NV). Complete regression of leakage and best‐corrected visual acuity (BCVA) were key secondary end‐points. Results: At Month 12, there was a statistically significant difference of −2.83 mm² in the least square mean change in NV area between the ranibizumab monotherapy and PRP group, favouring ranibizumab (95% CI [−5.45; −0.21], p = 0.0344). At Month 3, 67%/0%/67% of the patients in the ranibizumab/PRP/combination groups, respectively, showed complete regression of leakage from NVs, while at Month 12, 28%/8%/18% showed complete regression of leakage from NVs. BCVA change was greater in the ranibizumab group compared with the PRP monotherapy group at Month 12 (+1.6 letters; 95% CI [−2.3; 5.5] versus −3.9 letters; 95% CI [−7.8; −0.1], p = 0.0495). Conclusions: Ranibizumab monotherapy is an alternative treatment option to laser treatment in patients with PDR. Ranibizumab showed stronger effects on NV leakage and area reduction while offering better visual acuity results than PRP alone. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naïve patients with branch retinal vein occlusion (BRVO) enrolled in the LUMINOUS™ study. Study design: A 5-year, global, prospective, multicenter, observational, open-label study conducted in a clinical practice (real-world) setting at outpatient ophthalmology clinics that recruited 30,138 consenting adult patients from all approved indications for ranibizumab across 42 countries. Patients with BRVO were treated according to the local ranibizumab label of the participating countries. Mean change in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters from baseline to Year 1, treatment exposure during Year 1, and adverse events (AEs) over 5 years were assessed. Results: Of the 1366 recruited BRVO patients, 405 were treatment-naïve at baseline with a mean (standard deviation [SD]) age of 67.9 (12.5) years, 57.5% were female, and 71.8% were White. At Year 1 (n = 189), the mean (SD) VA gain was 11.9 (17.66) letters from a baseline of 49.2 (±20.32) letters with a mean (SD) of 5.0 (2.34) injections. VA gains were higher in patients (n = 83) who received 6–9 injections (13.6 [20.16] letters) than in those who received 2–5 injections (n = 92, 11.7 [15.43] letters), or 1 injection (n = 14, 3.6 [13.72] letters). Patients with baseline VA <23 letters had numerically highest VA gains (n = 20, 31.1 [24.48] letters). Over 5 years, the rate of ocular/non-ocular AEs was 7.4%/9.1% and serious AEs was 0.3%/4.4% in treatment-naïve BRVO patients (n = 405). Conclusions: One year results from the LUMINOUS real-world study showed a clinically meaningful VA improvement with ranibizumab in treatment-naïve patients with BRVO; numerically higher VA gains were achieved in patients who received more injections and those with poor baseline VA. No new safety signals were observed. [ABSTRACT FROM AUTHOR]

Purpose: The non-interventional OCEAN study (NCT02194803) evaluated frequency and monitoring of ranibizumab injections for retinal vein occlusion (RVO) in routine practice in Germany. Methods: RVO patients (including branch and central RVO (BRVO/CRVO)) receiving ranibizumab were included. Best-corrected visual acuity (BCVA) testing, imaging and treatment were performed at the investigators' discretion and documented over 24 months. Results: Overall, 744 RVO patients (27% BRVO, 16% CRVO, remaining unspecified RVO) were included. For 74% of patients, data were available for the 12-month visit and for 56% for the 24-month visit. Mean baseline BCVA was 52.0 Early Treatment for Diabetic Retinopathy Study (ETDRS) letters (BRVO: 55.9, CRVO: 43.9). BCVA improved rapidly within the first 3 months, reaching 64.3 letters at 12 months and 64.7 at 24 months. CRVO patients showed less improvement than those with BRVO. Patients received a median of 4 (5) injections over 12 (24) months, with 100% of patients receiving injections at baseline, 70% at Month 1 and 81% at Month 2. Overall, 40% of patients demonstrated a ≥15 letter increase within the first 3 months (42% BRVO, 46% CRVO). Patients with low initial BCVA (<50 letters) showed greater improvement than patients with higher baseline BCVA. Due to considerable loss to follow-up, the number of injections and optical coherence tomography (OCT) examinations were not associated with the change in BCVA. Conclusion: Patients with RVO in routine practice in Germany received fewer injections and fewer OCT examinations than in clinical trials. CRVO patients showed less and later improvement compared to BRVO patients. [ABSTRACT FROM AUTHOR]

Introduction: The 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.Methods: Adults 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.Results: The 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.Conclusion: Under-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.Funding: Novartis Pharma GmbH, Nuremberg, Germany. [ABSTRACT FROM AUTHOR]