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Aim To evaluate the incidence of ocular adverse events after loading phase of the brolucizumab therapy in patients with neovascular age-related macular degeneration (nAMD) in real-life clinical practice – in treatment-naive patients and in patients after switching from another anti-VEGF agent. Another aim was to evaluate treatment outcomes in patients with adverse events. Methods This is a multicentre, retrospective, observational study from 16 application centres in the Czech Republic. Patients diagnosed with nAMD were treated with brolucizumab in a fixed regimen of loading phase (3 injections administered at one-month intervals) and the mean follow-up period was 120 ± 10 days after the first injection. The incidence of adverse events and the development of best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with complications were evaluated. A total of 1,098 eyes were followed up, of which 783 were treatment-naive and 315 eyes were after switching from another anti-VEGF agent. Results Adverse events were recorded in 42 eyes (3.83%), of which 30 eyes were treatment-naive (2.7%) and 12 eyes were post-switch (1.09%). The mean baseline BCVA ± SD was 56.7 ± 10.7 ETDRS chart letters in the group of patients with adverse events, 58.8 ± 10.1 letters in treatment-naive patients, and 51.4 ± 10.2 letters in patients after switch from another anti-VEGF agent. The mean baseline CRT ± SD was 432.2 ± 154.7 μm, being 435.8 ± 137.3 μm in treatment-naive patients and 424.5 ± 186.6 μm in patients after switch from another anti-VEGF agent. At the end of the follow-up, the mean BCVA ± SD was 53.4 ± 9.5 ETDRS charts letters in patients with adverse events, 55.6 ± 10 letters in treatment-naive patients, and 47.6 ± 10 letters in patients after switching from another anti-VEGF agent. The mean CRT ± SD at the end of the follow-up was 300.7 ± 115.7 μm in the total patient cohort, 285.2 ± 78.8 μm in treatment-naive patients and 334.5 ± 165.4 μm in patients after switching from another anti-VEGF agent. Conclusion We observed the development of adverse events in the form of intraocular inflammation or vasculitis with subsequent decrease in BCVA in 3.83% of cases after loading phase of the brolucizumab therapy. The decrease in BCVA was reversible in most cases after initiation of anti-inflammatory steroid treatment. From a functional and morphological point of view, we did not demonstrate any statistically significant difference between the groups of treatment-naive patients and patients after switching from another anti-VEGF agent.

Aim: Presentation of the 1-year results of aflibercept treatment in patients suffering from diabetic macular edema (DME) and comparison of the response to treatment of patients with different baseline central retinal thickness (CRT). Methods: This was a multicentre, retrospective observational study of a series of cases. Patients with DME were treated in a fixed regimen (5 injections at 1-monthly intervals and then injections at 2-monthly intervals). The period of follow-up was 12 months. The development of best corrected visual acuity (BCVA) and CRT was evaluated. Measurements were performed prior to the commencement of treatment and then after 4, 6, 8, 10, and 12 months. Results: The therapeutically naive group consisted of 82 eyes of 79 patients. The total cohort of patients was divided into 3 groups according to the baseline values of CRT. The first group was composed of 28 eyes with baseline CRT < 450 μm (34.1%), the second included 25 eyes with CRT in the range of 450–550 μm (30.5%), and the third group consisted of 29 eyes with baseline CRT > 550 μm (35.4%). The average baseline BCVA and SD in the first group was 66 ±7.1 letters ETDRS optotypes, and then 70 ±7 letters, 69.6 ±7.3 letters, and 71.3 ±7 letters at the follow-ups after 4, 8, and 12 months. The average baseline value of CRT and SD in the first group was 379 ±48.6 μm, and then 337.1 ±76.5 μm, 320.2 ±74.1 μm, and 315.1 ±62.2 μm after 4, 8, and 12 months. The average baseline BCVA and SD in the second group was 64.1 ±9.7 ETDRS letters, and then 66.9 ±10 letters, 70 ±9.9 letters, and 70.5 ±11.5 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the second group was 497.4 ±76.4 μm, and then 376.5 ±106.1 μm, 360.8 ±70 μm, and 351.3 ±91.3 μm after 4, 8, and 12 months. In the third group, the average baseline value of BCVA and SD was 59.7 ±10.4 ETDRS letters, and then 65 ±10.6 letters, 64.8 ±9.6 letters, and 67 ±10 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the third group was 639.4 ±79.6 μm, and then 396.7 ±147.1 μm, 416.9 ±139.8 μm, and 368.5 ±109.9 μm after 4, 8, and 12 months. All these changes were statistically significant (p < 0.05). Conclusion: Aflibercept treatment in a fixed regimen in patients suffering from DME results in a statistically significant improvement in BCVA and a decrease in CRT in the first year of treatment. Patients with a higher baseline CRT showed the best anatomical and functional results of the 1-year treatment with aflibercept.

To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]).Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.F Hoffmann-La Roche.

Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).MethodsSetting: Multicentre.Design: Randomised, double-masked, parallel-group, phase III equivalence study.Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ.Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.

Aims: To examine the effectiveness and safety of Nd:YAG laser vitreolysis in patients with symptomatic vitreous floaters. Material and Methods: This was a single-centre study of adult patients with symptomatic vitreous floaters who underwent laser vitreolysis. Patients treated between 1/2020 and 10/2021 were included. Intraocular pressure was measured by non-contact tonometry before and one month after treatment. Colour fundus photography, slit lamp examination in mydriasis, best corrected visual acuity, optical coherence tomography, and ultrasound examinations were performed before treatment. The patients completed a questionnaire to subjectively rank the degree of impairment associated with the floaters before and between 1 and 2 months after treatment. Results: 89 eyes from 84 patients were included in the study, with a slight predominance of women (53%). A Weiss ring was present in 46%, and other types of vitreous opacity were found in 54%. Before treatment, 69% evaluated floaters as very troublesome (i.e., a value of 4 or 5 on a 1–5 scale). After treatment, 42% indicated subjective improvement (9% viewed the treatment as a complete success and 33% as a significant success). In 33% of eyes there was a partial improvement, i.e., some floaters could still be seen, and in 17% there was no improvement; 8% of patients were dissatisfied with the treatment results. There was no statistically significant difference in improvement between the group with Weiss rings and the group with other types of floaters. The procedure itself and the subsequent observation period were without complications, i.e., no cases of intraocular pressure elevation, cataract formation or retinal complications. Intraocular pressure did not significantly change from the pre-procedure value (p = 0.29). Average best corrected visual acuity after treatment was 0.97, thus it did not differ significantly from the pre-treatment values (p = 0.82). Conclusion: Nd:YAG laser vitreolysis subjectively improved floater-related symptoms in treated eyes. The lack of an objective measurement of treatment success is a limiting factor. Laser vitreolysis is more suitable for solitary than diffuse vitreous opacities.

Objective: The aim of this comprehensive paper is to acquaint the readers with evaluation of the retinal images using the arteficial intelligence (AI). Main focus of the paper is diabetic retinophaty (DR) screening. The basic principles of the artificial intelligence and algorithms that are already used in clinical practice or are shortly before approval will be described. Methodology: Describing the basic characteristics and mechanisms of different approaches to the use of AI and subsequently literary minireview clarifying the current state of knowledge in the area. Results: Modern systems for screening diabetic retinopathy using deep neural networks achieve a sensitivity and specificity of over 80 % in most published studies. The results of specific studies vary depending on the definition of the gold standard, number of images tested and on the evaluated parameters. Conclusion: Evaluation of images using AI will speed up and streamline the diagnosis of DR. The use of AI will allow to keep the quality of the eye care at least on the same level despite the raising number of the patients with diabetes.

Background Despite the significant impact of retinal diseases such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), there is a limited understanding of how these conditions are managed in Central and Eastern Europe (CEE). Objectives To provide a comprehensive overview of the clinical and economic burden of wAMD and DME in CEE and the status quo associated with their management. Methods A narrative literature review was undertaken to identify existing data on wAMD and DME, including epidemiology, economic burden, clinical guidelines, and available and reimbursed treatments. Data were collected from relevant sources such as PubMed, ophthalmology associations, national statistical offices, and government agency websites; practical viewpoints were provided by local ophthalmologists and healthcare economics experts in CEE. Results Epidemiological data on wAMD and DME are limited in CEE, and intercountry comparison is difficult because of differences in data collection methodologies. There are effective treatment options for wAMD and DME, and international guidelines advocate the use of intravitreal anti-vascular endothelial growth factor injections as first-line therapy. Local expert organizations broadly support these recommendations; nevertheless, no clinical practice guidelines exist on the treatment of wAMD and DME in CEE. Access to and reimbursement of anti-vascular endothelial growth factor agents vary significantly in the region and, as a result, many patients remain untreated or inadequately treated. Conclusions There is an urgent need for the creation of a wAMD/DME treatment program in CEE to ensure that patients have timely access to the most appropriate treatments.

Purpose: Purpose of this article is to present a case report of a patient with uveal effusion syndrome who underwent deep posterior sclerotomy. Case report: A 73-year-old patient with unilateral decrease in the best corrected visual acuity, ablation of choroid and secondary retinal detachment in the right eye was admitted to our clinic for examination in November 2017. At the first examination, the best corrected visual acuity in the right eye was 0.3, in the left eye 1.0. Intraocular pressure was 16 mmHg in the right eye and 21 mmHg in the left eye. After performing ultrasound biomicroscopy of the anterior segment (Accutome, Keeler, USA), ultrasound sonography of the affected eye (Accutome, Keeler, USA), magnetic resonance imaging, computed tomography, abdominal ultrasound and blood tests, we concluded the finding as uveal effusion syndrome. We initiated a conservative treatment consisting of oral administration of carbonic anhydrase inhibitor in combination with topical use of prostaglandin analogue. Despite conservative treatment the best corrected visual acuity of the affected eye decreased to 0.05 so we proceeded to a surgical procedure – deep posterior sclerotomy with perioperative scleral sampling for histological examination (detection of glycosaminoglycans in the sclera wall by Alcian blue staining), which was negative. This histological result ranks the patient as the third type of uveal effusion syndrome (ie, non-nanophthalmic with a normal sclera). After the operation both the ablation of choroid and retinal detachment reattached and the best corrected visual acuity in the right eye improved to 0.3. After the subsequent cataract surgery, the ablation of choroid and retinal detachment occurred again, this time with spontaneous recovery. Postoperatively, the best corrected visual acuity in the right eye was 0.5 and at the last check-up at our clinic 0.6. Conclusion: Deep posterior sclerotomy is a method of choice of surgical treatment for uveal effusion syndrome that does not respond to conservative therapy.

Aim: To present the results of a 2-year therapy with aflibercept in real-life practice in a mixed regimen in patients with a neovascular form of age-related macular degeneration (nAMD) and to evaluate the treatment response of various types of choroidal neovascular membranes (CNV) – occult (Type 1), classic (Type 2) and minimally classic (Type 4). Methods: This was a multicentric, prospective, observational study of a series of cases. Patients diagnosed with the wet form of AMD were treated in a fixed regimen (3 injections at intervals of 1 month and then injections at 8-week intervals) in the first year, and in a pro re nata regimen (PRN) in the second year. The period of investigation was 24 months. The development of the best corrected visual acuity (BCVA) was evaluated by means of ETDRS optotypes (Early Treatment Diabetic Retinopathy Study) and the central retinal thickness (CRT). Measurements were performed prior to the commencement of therapy and then after 4, 8, 12, 16, 20 and 24 months. Results: The therapeutically naïve group consisted of 135 eyes of 135 patients. Sixty-one eyes suffered from CNV of the 1st type, 50 eyes from CNV of the 2nd type and 24 eyes from CNV of the 4th type. The average baseline of BCVA ± SD in Type 1 CNV was 56.1 ± 10.8 letters of ETDRS, and then, respectively, 62.2 ± 12.9 letters, 62.8 ± 15.1 letters and 59.4 ± 13.2 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD for Type 1 CNV was 442.4 ± 194.9 µm, and then 302.5 ± 144.4 µm, 277.7 ± 106.5 µm and 327.6 ± 138.6 µm at months 4, 12 and 24. The average baseline value of BCVA ± SD in Type 2 CNV was 55.6 ± 9.9 letters of ETDRS, and then 62.5 ± 11.1 letters, 62.5 ± 14.2 letters and 60.6 ± 15.1 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 2 CNV was 446.8 ± 159.1 µm, and then 327.4 ± 127.0 µm, 316.7 ± 139.1 µm and 352.5 ± 132.4 µm at 4, 12 and 24 months. In Type 4 CNV, the average baseline value of BCVA ± SD was 56.7 ± 9.0 letters of ETDRS, and then 59.1 ± 10.6 letters, 59.2 ± 12.6 letters and 58 ± 8.8 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 4 CNV was 492.1 ± 187.0 µm, and then 333.3 ± 137.5 µm, 326.7 ± 122.4 µm and 328.4 ± 132 µm at months 4, 12 and 24. All these changes were statistically significant ( p Conclusion: Therapy with aflibercept in a mixed regimen in patients with the wet form of AMD during the investigation resulted in a statistically significant improvement in BCVA and decrease in CRT in both the occult and classic type of CNV. Both the functional and anatomical response to therapy was worse in the minimally classic type (Type 4) of CNV. Summary declaration: Patients suffering from the neovascular form of age-related macular degeneration were treated with aflibercept in a mixed regimen (fixed in the first year and PRN in the second year). After 24 months of examination, a significant improvement of both morphological and functional results was observed in three types of choroidal neovascular membrane.

Introduction: To compare the results and complication rates of a 25-gauge pars plana vitrectomy (PPV) with gas tamponade for rhegmatogenous retinal detachment (RRD) between experienced and inexperienced surgeons.Materials and Methods: This is a retrospective comparative consecutive case series study of patients with uncomplicated RRD treated with 25g PPV with gas tamponade. Patients were divided into 2 groups: In experienced surgeon group (ESG) the procedure was performed by an experienced vitreoretinal surgeon and in inexperienced surgeon group (ISG) the procedure was performed by 2 inexperienced surgeons. Anatomical and functional results and complication rates were compared between the two groups.Results: 216 eyes were included in the study. In the ESG (106 eyes), the single operation success rate was 94.3%, and the final success rate was 100%. In the ISG (110 eyes), the single operation success rate was 93.6%, and the final success rate was 100.0%. The difference in single surgery success rate between groups was not statistically significant (P = 0.828). The mean postoperative BCVA improvement was 0.348 decimal in ESG and 0.405 decimal in ISG (P = 0.234). The difference in complication rates between groups was not significant.Conclusions: A 25g PPV with gas tamponade for treatment of RRD yields excellent anatomical results and improvement in BCVA. With good technique and use of modern vitrectomy machines and instruments, even inexperienced surgeons can achieve high single operation success rate, suggesting a short learning curve. The complication rate is comparable between experienced and inexperienced surgeons.

Purpose. To compare the effect of different types of intraocular tamponade and different types of postoperative positioning on the closure of idiopathic macular hole (IMH). Methods. Prospective randomized clinical trial enrolling 104 eyes of 100 patients (age, 57–87 years) undergoing MH surgery. All patients were operated on by an experienced surgeon using 25-gauge pars plana vitrectomy (PPV) and internal limiting membrane (ILM) peeling. Patients were randomized according to the type of intraocular tamponade and postoperative positioning into the following four groups: SF6 + nonsupine reading position (n = 26) (group 1), air + nonsupine reading position (n = 25) (group 2), air + prone position (n = 26) (group 3), or SF6 + prone position (n = 27) (group 4). The follow-up period was 6 months. Results. MH closure was achieved in 87 eyes (83.7 %) in the overall sample after the first surgery, with closure rates of 100%, 56%, 84.6%, and 92.6% in groups 1, 2, 3, and 4, respectively. The group 2 was significantly less successful compared to the other three groups ( p p = 0.219). MH with sizes over 400 µm was closed in 70.9% of cases after the first surgery, with both groups with air tamponade being significantly less successful than group 1. The nonsupine reading position was subjected to a better subjective evaluation in terms of postoperative comfort and quality of sleep, with no differences between air and SF6 tamponade tolerance. Conclusion. PPV with ILM peeling, intraocular tamponade, and positioning remains the basic surgical approach in the treatment of IMH. For MH ≤ 400 µm, a high closure rate can be achieved by combining air tamponade and nonsupine reading position. For macular holes >400 µm, the greatest anatomical success can be achieved by using the SF6 tamponade in combination with the nonsupine reading position.

Objective: The aim of this comprehensive paper is to acquaint the readers with innovative approaches in the treatment of retinal diseases, which could in the coming years to get into clinical practice. Retinal prostheses, retinal pigment epithelial (RPE) transplantation, gene therapy and optogenetics will be described in this paper. Methodology: Describing the basic characteristics and mechanisms of different types of therapy and subsequently literary minireview clarifying the current state of knowledge in the area. Results: Retinal prostheses, RPE transplantation, gene therapy and optogenetics offer yet unexplored possibilities and are considered as the future of treatment of retinal diseases where classical pharmacotherapy or surgical treatment are no longer sufficient. However, all these methods challenge not only in the innovative technical implementation itself, but also for the ethical, administrative and economic demands. Conclusion: There will be certainly interesting development in the treatment of retinal diseases, but it is not possible to fully estimate which modality of treatment will be dominant in the future.

Purpose: To evaluate the effect of one intravitreal injection of expansile gas in the treatment of vitreomacular traction (VMT). Methods: A retrospective review of eyes with VMT treated with singl injection of 0,3 ml of 100% C3F8 gas was performed. The procedure was performed on an outpatient basis under topical anesthesia. Results: Twelve consecutive patient (14 eyes) with symptomatic VMT underwent pneumatic vitreolysis. Mean extend of vitreomacular adhesion was 490,5 µm (408-751). A posterior vitreous detachment developed in 13 eyes (92,9 %) after a single gas injection, in 11 eyes (84,6 %) during the first month of follow-up, in 2 eyes within two month of injection. Mean baseline and last BCVA were 0,5 (0,16-0,18) and 0,67 (0,2-1,0) respectively (p

Purpose: To evaluate the long-term results of combining cataract surgery, intraocular lens (IOL) implantation, and Descemet membrane endothelial keratoplasty with peripheral stromal support (DMEK-S). Methods: The outcomes of 107 eyes of 37 patients who had undergone a combination of cataract surgery, IOL implantation, and DMEK-S between October 2007 and February 2015 were retrospectively evaluated. The average follow-up duration was 18.2 ± 18.3 months (range, 6–84 months). Changes in uncorrected and corrected distance visual acuity, spherical equivalent, and corneal endothelial cell density were analyzed. Intraoperative and postoperative complications were also recorded. Results: The mean logMAR uncorrected distance visual acuity improved from 0.92 ± 0.60 preoperatively to 0.33 ± 0.33, 0.28 ± 0.25, 0.24 ± 0.20, and 0.27 ± 0.27 at 6, 12, 24, and 36 months postoperatively (P < 0.001), respectively. The mean logMAR corrected distance visual acuity improved from 0.62 ± 0.65 preoperatively to 0.17 ± 0.29, 0.13 ± 0.21, 0.07 ± 0.16, and 0.11 ± 0.23 at 6, 12, 24, and 36 months postoperatively (P < 0.001), respectively. The mean endothelial cell density decreases were 50.7% ± 21.1%, 50.8% ± 19.8%, 60.7% ± 16.6%, 62.2% ± 11.8%, and 61.8% ± 20.0% at 6, 12, 24, 36, and 48 months after surgery, respectively. Similar trends, although with slightly better visual outcomes, were found in the subgroup of patients without other eye diseases. The mean final deviation from intended spherical equivalent was 0.77 ± 1.19 D, representing a hyperopic shift. Conclusions: A combined procedure of cataract surgery, IOL implantation, and DMEK-S is an effective method of treatment in patients with combined corneal disease and cataract, maintaining visual rehabilitation in the long term. Future developments should be performed to minimize the incidence of complications. D. P. Piñero has been supported by the Ministry of Economy, Industry and Competitiveness of Spain within the program Ramón y Cajal (RYC-2016-20471).

The aim of the study Retrospective evaluation of the first 12 months treatment of macular edema in BRVO with ranibizumab based on anatomical and functional parameters. Methods 54 eyes with macular edema complicating BRVO were included in the study, with an average initial best corrected visual acuity 4/16 ETDRS charts, an average central retinal thickness 512.3 μm, and in average 4 months till the beginning of treatment with ranibizumab. After 3 initial injections of 0.5 mg ranibizumab treatment was performed in pro re nata regimen, with adjuvant laser (grid laser photocoagulation) as an additional treatment option. The number of injections administered, the number of eyes where grid laser photocoagulation was provided, functional parameters as a letter gain and BCVA (eyes with final BCVA ≥ 4/8 ETDRS, final BCVA in according to initial BCVA) and anatomical parameters as a mean CRT and CRT ≤ 250 μm, respectively ≤ 300 μm were evaluated. Results In the whole group, an average of 4.8 injections of ranibizumab were administered in the first 12 months. Grid laser photocoagulation was performed in 42 eyes: in 8 eyes prior to the beginning of treatment with ranibizumab, 7 eyes before and during the treatment, 29 eyes only during the treatment. The main gain of letters after 12 months of treatment was +16.5 letters, with 63¨% (n = 34) eyes earning ≥ 15 letters. In the whole group 72 % (n = 39) eyes achieved the resulting BCVA ≥ 4/8 ETDRS after 12 months of treatment. The eyes with initial BCVA ≥ 4/10 ETDRS resulted in BCVA ≥ 4/8 ETDRS in 96 % (n = 23 eyes) and 11 eyes even achieved BCVA ≥ 4/4. The mean CRT after 12 months of treatment was 290.3 μm, 33.3 % of eyes had final CRT ≤ 250 μm, and 64.8 % had final CRT ≤ 300 μm. Conclusion When applying a relatively low number of injections in the first year of treatment with ranibizumab, the final best corrected visual acuity was very good at the end of the observation period, and its dependence on the initial best corrected visual acuity was confirmed. Satisfactory results of central retinal thickness were found as well. Key words: branch retinal vein occlusion, macular edema, ranibizuma.

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (−111.6 μm) and DEX implant 0.35 mg (−107.9 μm) than sham (−41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Importance Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment. Objective To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab. Design, Setting, and Participants This randomized, double-masked, parallel-group phase 3 equivalence study was conducted in 75 centers in 9 countries from March 14, 2018, to December 9, 2019, among 705 participants 50 years or older with neovascular age-related macular degeneration with active subfoveal choroidal neovascularization lesions. Analysis was performed on an intent-to-treat basis. Interventions Intravitreous injection of SB11 or ranibizumab, 0.5 mg, every 4 weeks through week 48. Main Outcomes and Measures Preplanned interim analysis after all participants completed the week 24 assessment of primary efficacy end points at week 8 for change from baseline in best-corrected visual acuity (BCVA) and week 4 for central subfield thickness (CST), with predefined equivalence margins for adjusted treatment differences of −3 letters to 3 letters for BCVA and −36 μm to 36 μm for CST. Results Baseline and disease characteristics among 705 randomized participants (403 women [57.2%]; mean [SD] age, 74.1 [8.5] years) were comparable between treatment groups (SB11, 351; ranibizumab, 354). Least-squares mean (SE) changes in BCVA from baseline at week 8 were 6.2 (0.5) letters in the SB11 group vs 7.0 (0.5) letters in the ranibizumab group, with an adjusted treatment difference of −0.8 letter (90% CI, −1.8 to 0.2 letters). Least-squares mean (SE) changes in CST from baseline at week 4 were −108 (5) μm in the SB11 group vs −100 (5) μm in the ranibizumab group, with an adjusted treatment difference of −8 μm (95% CI, −19 to 3 μm). Incidences of treatment-emergent adverse events (231 of 350 [66.0%] vs 237 of 354 [66.9%]), including serious treatment-emergent adverse events (44 of 350 [12.6%] vs 44 of 354 [12.4%]) and treatment-emergent adverse events leading to study drug discontinuation (8 of 350 [2.3%] vs 5 of 354 [1.4%]), were similar in the SB11 and ranibizumab groups. Immunogenicity was low, with a cumulative incidence of antidrug antibodies up to week 24 of 3.0% (10 of 330) in the SB11 group and 3.1% (10 of 327) in the ranibizumab group. Conclusions and Relevance These findings of equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab support the use of SB11 for patients with neovascular age-related macular degeneration. Trial Registration ClinicalTrials.gov Identifier:NCT03150589

To evaluate one-year follow-up outcomes of treatment with aflibercept in patients with newly diagnosed wet age-related macular degeneration (ARMD).Retrospective evaluation of treatment of 28 eyes of 28 patients with an average age of 74.2 years who were treated with aflibercept at the Department of Ophthalmology at Královské Vinohrady University Hospital. All patients were treated according to the summary of product characteristics (SPC), i.e. with an initial 3 injections at monthly intervals, followed by 4 injections every 2 months. We evaluated the change in best corrected visual acuity (BCVA) on Early Treatment of Diabetic Retinopathy Study (ETDRS) optotypes, and the change of central retinal thickness (CRT) with the aid of optical coherence tomography (OCT).The average initial BCVA value was 61.5 letters of ETDRS optotype. After the initial 3 injections, BCVA improved to 70.5 letters, after one year of treatment there was a slight decrease to 68.1 letters. Better or same visual acuity was recorded in 25 eyes (89.3%), a deterioration occurred in 3 eyes (10.7%). CRT was reduced from an initial average value of 360.9 µm to 253.3 µm after the initial phase and to 233.8 µm after one year of treatment. At the end of the observation period, 25 eyes (89.3%) were without signs of activity of the pathology. No complications of treatment were recorded.In our cohort we confirm the efficacy and safety of the aflibercept preparation in patients with newly diagnosed wet form ARMD. By adhering to a fixed therapeutic regime it is possible to obtain similarly excellent results of treatment in real clinical practice as in clinical trials. Key words: aflibercept, anti-VEGF therapy, optical coherence tomography, wet form ARMD The authors of the study declare that no conflict of interest exists in the compilation, theme and subsequent publication of this professional communication, and that it is not supported by any pharmaceuticals company.

Purpose. To evaluate the outcomes of the hybrid technique of posterior lamellar keratoplasty (Descemets' membrane endothelial keratoplasty with stromal rim, DMEK-S) in eyes with multiple ocular pathologies. Methods: A retrospective case control study of the consecutive group of all eyes with combined ocular pathologies which underwent DMEK-S keratoplasty. We evaluated the number of pre- and post-operative complications; uncorrected distance visual acuity (UDVA); corrected distance visual acuity (CDVA) and endothelial cell density (ECD). The first group (Group 1 - 100 eyes) was compared to a control group of eyes (Group 2 - 145 eyes) without combined ocular pathologies, which were operated throughout the same time period. Comparisons were made in the 12th month of the follow-up. Results: Both the UDVA and the CDVA statistical values 12 months after the surgery were significantly better in Group 2. ECD was comparable in both groups. The number of complications during surgery was considerably higher in Group 1, where a certain type of complication occurred in 15 eyes (15%), while in Group 2 this complication occurred only in 9 eyes (6.2%). In Group 1 a slightly higher number of rebubbling cases (52% vs. 48.3%) occurred, as well as more than twice as many cases of primary graft failure (34% vs. 15.7%) compared to Group 2. Conclusion: DMEK-S - hybrid endothelial transplantation in complicated eyes in the evaluated group of patients led to a noticeable improvement of visual acuity. When compared to surgeries in uncomplicated eyes, DMEK-S results in a higher rate of postoperative complications, especially graft detachment and primary failure.

Background To present a coincidence of macular telangiectasia type 2 and solitary retinal astrocytic hamartoma in one patient. Case presentation A 50-year-old woman was examined in the Department of Ophthalmology of University hospital Kralovske Vinohrady for complaints of metamorphopsia in her left eye. Her uncorrected visual acuity (VA) was 4/4 on Early Treatment Diabetic Retinopathy Study charts (ETDRS), on the retina of her left eye white, prominent, partially calcified tumour 1 disc diameter in diameter, 1,5 disc diameter from the foveola was detected on the retina. In the macular region of both eyes, parafoveal greying with crystalline deposits and changes in retinal vasculature were visible. We performed following examinations: fluorescein angiography (FA), B-scan ultrasound, spectral domain optical coherence tomography (SD-OCT) including photo documentation. FA showed partial hyperfluorescence of mulberry-like surface of the tumour typical for retinal astrocytic hamartoma. Parafoveally in both eyes, leakage from parafoveal telangiectasia was apparent. SD-OCT showed cystoid space in the macular region of both eyes as well as changes in inner and outer photoreceptor segment junction in left eye. SD-OCT of the tumour showed proliferation in retinal nerve fibre layer with normal structure of underlying retinal layers and choroid. Ultrasound examination of the tumour detected solid, highly echogenic prominent tumour with high reflectivity and acoustic shadow. Conclusion A coincidence of two relatively rare clinical units, macular telangiectasia type 2 and solitary astrocytic hamartoma was detected as a unique and rare observation.