Decrease In Central Retinal Thickness Research Articles

Real-World Experience with Brolucizumab Compared to Aflibercept in Treatment-Naïve and Therapy-Refractory Patients with Diabetic Macular Edema.

Background: To report on the outcome of intravitreal brolucizumab compared to aflibercept in patients with diabetic macular edema (DME). Methods: Prospective, observational, study in 35 eyes of 24 patients with a loading dose of five injections of 6 mg brolucizumab every 6 weeks (q6w, treatment-naïve eyes) or a minimum of two injections of brolucizumab q6w after the switch (recalcitrant DME eyes), followed by a treat and extend (T&E) regimen. The results were compared with 40 eyes of 31 DME patients who were treated with aflibercept. The data were obtained from the Berlin Macula Registry. The primary outcome measure was the change in best-corrected visual acuity (BCVA) at week 36. Secondary outcome measures were the change in central retinal thickness (CRT) and the treatment intervals until week 36. Results: BCVA increased significantly in treatment-naïve DME eyes treated with either brolucizumab (+0.12 logMAR, +6.4 letters, p = 0.03) or aflibercept (+0.19 logMAR, +9.5 letters, p = 0.001). In recalcitrant DME eyes, BCVA also increased significantly after switching to brolucizumab (+0.1 logMAR, +5 letters, p = 0.006) or aflibercept (+0.11 logMAR, +5.5 letters, p = 0.02). All treatment-naïve and recalcitrant DME eyes had a significant decrease in CRT after treatment with brolucizumab (p = 0.001 and p < 0.001) or aflibercept (p = 0.0002 and p = 0.03). At week 36, the mean treatment interval for brolucizumab was 11.3 weeks, while for aflibercept, it was 6.5 weeks for treatment-naïve eyes and 9.3 weeks vs. 5.3 weeks for pretreated eyes. Conclusions: In routine clinical practice, patients with treatment-naïve and recalcitrant DME showed a favorable response to brolucizumab and aflibercept therapy, with a reduced injection frequency after brolucizumab treatment.

Comparison of ranibizumab, aflibercept, and dexamethasone implant monotherapy in treatment-naive eyes with diabetic macular edema: A 12-month real-life experience.

To compare the functional and anatomical outcomes of ranibizumab, aflibercept, and dexamethasone implant monotherapy in treatment-naive eyes with diabetic macular edema (DME) in real-life conditions. In this retrospective cohort study, data were obtained from the hospital database of treatment-naive patients diagnosed with DME with at least 12 months of follow-up. Best corrected visual acuity (BCVA) and central retinal thickness (CRT) at baseline, third month, sixth month, ninth month, and 12th month were recorded. In addition, a subgroup analysis was performed based on having good (below 0.4 log of minimum angle of resolution [logMAR]) or poor (0.4 logMAR and above) vision. A total of 219 eyes of 142 patients were included in the study. The change in the mean BCVA from baseline to 12th month was from 0.62 logMAR to 0.42 logMAR (P < 0.001) in the ranibizumab group, from 0.56 logMAR to 0.39 logMAR (P < 0.001) in the aflibercept group, and from 0.46 logMAR to 0.5 logMAR (P = 0.653) in the dexamethasone group. There was no significant difference between the treatment groups at any time point (P > 0.05). The mean amount of CRT change was statistically significant at 12 months in all groups (ranibizumab: -175.4 µm, aflibercept: -153.3 µm, dexamethasone: -71.4 µm) (P < 0.05). In eyes with initially good vision, the final BCVA at 12 months was significantly better in the ranibizumab group compared to the dexamethasone group (P = 0.008). The aflibercept group had better visual acuity than the dexamethasone group, but there was no statistically significant difference (P = 0.059). There was no significant difference in final BCVA in eyes with initially poor vision. No serious ocular/systemic complications were noted. At the 12th month, a significant decrease in CRT was achieved in all treatment groups, whereas only ranibizumab and aflibercept groups had a significant BCVA increase. In eyes with initially good vision, the final BCVA at 12 months was better in the ranibizumab group compared to the dexamethasone group, whereas it was similar in all groups having initially poor vision.

Short-term outcomes of treatment switch to faricimab in patients with aflibercept-resistant neovascular age-related macular degeneration.

To report short-term outcomes of treatment switch to faricimab in real-world patients with aflibercept-resistant neovascular age-related macular degeneration (AMD). Single-center, retrospective cohort study with chart-review using electronic injection database, electronic medical records, and optical coherence tomography (OCT) data from May to September 2023. A total of 50 eyes of 46 patients were analyzed. Faricimab treatment led to absence of fluid in 32% of the eyes and a reduction of fluid in 84% of the eyes. There was a statistically significant decrease in central retinal thickness (CRT) and pigment epithelial detachment (PED) height in those that responded to the switch (median difference: - 31μm, IQR: 55, p < 0.0001 and median difference: - 21μm, IQR: 36, p < 0.0001, respectively) and a statistically significant increase in CRT (median difference: + 19μm, IQR: 20, p = 0.0143) and no change in PED height (median difference: + 22μm, IQR: 64, p = 0.1508) in those that did not. Best-corrected visual acuity (BCVA) showed marginal decrease with low statistical significance. No ocular or systemic safety events were observed. Our findings suggest that switching to faricimab is generally safe and effective in patients with neovascular AMD who are otherwise difficult to treat and have residual fluid despite frequent injections with aflibercept. We observed a high rate of morphological response to the treatment switch, improvement of anatomical parameters with about one-third of patients having dry macula following a single injection, and a marginal change in BCVA. Sustainability of these results requires further investigation. ClinicalTrials.gov registration number: NCT06124677. Date of registration: 09/11/2023, retrospectively registered.

Lipid‐lowering therapy in the treatment of massive hard exudates in type 1 diabetes

Aims/Purpose: Today there is no approved medical therapy for hard macular exudates in diabetes and unfortunately this pathology often leads to significant visual loss. Purpose of our study was to assess whether long‐term lipid‐lowering therapy with fenofibrate could reduce the number and extension of massive macular exudates in Type 1 diabetes patients.Methods: There were 46 (92 eyes) Type 1 diabetes persons (18–42 years) with diabetic maculopathy and massive hard exudates included in this study. HbA1C ranging from 6% to 9%. The mean visual acuity was 0.3 ± 0.1. Patients were divided into two groups: main (22 person) and control (24 person). Exclusion criteria: patients on lipid‐lowering drugs, oral contraceptive pills, hormone replacement therapy, pregnant woman, familial hypercholesterolemia, hypothyroidism, chronic liver and kidney disease. All patients in the main group received fenofibrate 145 mg once a day for 8 months, patients in control group had conventional therapy. All patients had undergone standard ophthalmological examination, fundus photos and OCT scanning on presentation and during follow‐up visits. Patients were followed at 2, 6, 12 and 18 months after the start of the treatment.Results: In the main group anatomic result expressed by the reduction of number and extension of hard exudates, decrease in central retinal thickness was achieved in 77% of patients (17 patients, 34 eyes). Central retinal thickness in the main group decreased from mean 392 mkm to 255 mkm ± 30 mkm. Good functional result was achieved in 64% of patients (28 eyes), where visual acuity increased from 0.3 to 0.5 ± 0.1. This effect was stable for the whole follow‐up period. In the control group 74% of patients had no anatomic neither functional changes. In 15% of patients mean visual acuity slightly improved from 0.3 to 0.4 ± 0.05 with decrease in central retinal thickness from mean 386 mkm to 320 mkm ± 30 mkm due to better compensation of the main disease. In 15% the number and extension of hard exudates increased with further vision deterioration. No fenofibrate side effects were noticed in either group.Conclusions: Fenofibrate in Type 1 diabetic patients diminishes number of macular hard exudates, reduces macular oedema, improves visual acuity with stable effect over the time.

The First Results of a Full Loading Dose of Brolucizumab in the Treatment of DME

The aim of the study was to evaluate the efficacy and safety of brolucizumab in the Russian population of patients with diabetic macular edema. Patients and methods: 41 patients (29 women and 12 men) with diabetic retinopathy and diabetic macular edema of comparable age were included in the study. The patients were divided into 2 groups depending on the previous DME treatment. The first group included 24 patients (24 eyes) who had not previously received treatment: 9 men and 15 women, the average age of patients was 62.9 ± 9.3 years, the average best-corrected visual acuity was 0.40 ± 0.23, CTS 332 ± 87 microns, MV 9.65 ± 1.2 mm3. There were 17 patients (17 eyes) in the second group, they had previously received other antiangiogenic drugs, but retained the activity of the disease against the background of the treatment (1 man and 16 women), the average age of patients was 60.6 ± 8.3 years, the average best-corrected visual acuity was 0.40 ± 0.27, CTS 351.6 ± 149.0 microns, MV 9.3 ± 1.8 mm3. All patients received at least 5 intravitreal injections of brolucizumab (205 injections in total) at intervals of 6 weeks. The control examination was carried out 6 weeks after the last injection and a month after the fifth injection. The best-corrected visual acuity, intraocular pressure, central retinal thickness (CTS), macular volume (MV) were evaluated according to optical coherence tomography. Results. In the first group, a statistically significant increase in the best-corrected visual acuity was revealed from 0.40 ± 0.23 to 0.575 ± 0.27 (p = 0.05), the indicators of CTS and MV statistically significantly decreased. In the second group, only a decrease in CTS was detected, while the indicators of BCVA and MV did not show statistically significant changes. Conclusion. Patients with DME, who were treated with brolucizumab and who had not previously received treatment with other drugs, showed an improvement in anatomical and functional parameters, patients, who retained the activity of the disease against the background of the treatment, showed a slight decrease in the activity of the disease.

Pharmacogenetic Association between Allelic Variants of the Autophagy-Related Genes and Anti-Vascular Endothelial Growth Factor Treatment Response in Neovascular Age-Related Macular Degeneration.

Age-related macular degeneration (AMD) is the leading cause of late-onset blindness in elderly. The occurrence and development of AMD is a multifactorial complex process where autophagy plays an important role. The first-line drugs for neovascular AMD (nAMD) are inhibitors of VEGF, with up to 30% of patients having an incomplete response to treatment. Genetic factors may influence the response to anti-VEGF therapy and explain treatment outcome variability. We aimed to estimate the role of polymorphic markers of the MTOR (rs1064261, rs1057079, rs11121704, rs2295080), SQSTM1 (rs10277), ULK1 (rs11246867, rs3088051), MAP1LC3A (rs73105013) and ATG5 (rs573775) genes in the development of nAMD and the efficacy of anti-VEGF therapy response. Genotyping by allele-specific PCR was performed in 317 controls and 315 nAMD patients in the Russian population. Of them, 196 treatment-naive nAMD patients underwent three monthly intravitreal injections (IVIs) of aflibercept. Genotypic frequencies were compared with OCT markers of therapy effectiveness and best-corrected visual acuity (BCVA) measures. The main outcomes were the BCVA gain and decrease in central retinal thickness (CRT). MTOR-rs1057079-C, MTOR-rs11121704-C and MTOR-rs2295080-G alleles were associated with an increased risk of nAMD. The BCVA was increased in 117 (59.7%) patients by 10 [5-20] letters, did not changed in 59 (30.1%), and was decreased in 20 (10.2%) patients. ULK1-rs3088051 was associated with BCVA change. Among patients with the TT and CT genotypes for ULK1-rs3088051, an improvement in visual acuity was noted in 67.6% and 53.8% of cases, while in patients with the CC genotype, an increase in BCVA was recorded in 37.5% of cases (p = 0.01). The decrease in CRT was associated with SQSTM1-rs10277 (p = 0.001): it was significantly higher in TT (93 [58-122] mkm) and CT (66 [30-105] mkm) carriers compared to the CC genotype (47 [24-68] mkm). Other SNPs did not show significant associations with the outcome of anti-VEGF treatment. MTOR gene polymorphisms are moderately associated with the risk of nAMD. SQSTM1-rs10277 and ULK1-rs3088051 may influence short-term response to intravitreal anti-VEGF treatment. The results suggest that autophagy could be a target for future drugs to overcome resistance to anti-VEGF therapy.

Intravitreal Brolucizumab and Aflibercept for Polypoidal Choroidal Vasculopathy.

Purpose: To compare the effectiveness of intravitreal injections of brolucizumab and aflibercept in patients with polypoidal choroidal vasculopathy (PCV). Methods: In total, 62 treatment-naive PCV eyes (62 patients) treated with intravitreal brolucizumab or aflibercept were analyzed retrospectively. All patients received a monthly loading injection of antivascular endothelial growth factor for 3 months, followed by further injections as required. Visual and anatomical outcomes were compared between drugs after 12 months of treatment. Results: The improvement in best-corrected visual acuity after 12 months of treatment was not significantly different between the brolucizumab-treated (22 eyes) and aflibercept-treated groups (40 eyes). However, in the brolucizumab-treated group, there was a significantly greater decrease in central retinal thickness (172 vs. 147 μm; P = 0.031) and subfoveal choroidal thickness after treatment (51 vs. 29 μm; P = 0.025). In addition, the regression rate of polypoidal lesions was significantly higher in the brolucizumab-treated group (77.3%, 17/22 eyes) than that in the aflibercept-treated group (45.0%, 18/40 eyes; P = 0.014). Sterile intraocular inflammation showing mild vitritis was observed in 1 of the 22 eyes (4.5%) of brolucizumab-treated patients. Conclusion: Intravitreal brolucizumab injections for PCV showed visual improvement comparable to that of aflibercept during the 12-month treatment period. However, brolucizumab was more effective than aflibercept for the regression of polypoidal lesions and caused a greater decrease in central retinal thickness and subfoveal choroidal thickness.

Diurnal functional and anatomical changes in X-linked retinoschisis

BackgroundTo investigate the changes in macular cystic schisis (MCS) and sensitivity during the day in X-linked retinoschisis (XLRS) patients.MethodsTreatment-naïve patients with genetically verified XLRS underwent best-correlated visual acuity (BCVA) testing with ETDRS charts, spectral domain optical coherence tomography, and microperimetry (MP) twice a day, at 9 a.m. and 4 p.m., to measure changes in central retinal thickness (CRT), macular volume (MV), average threshold (AT), and fixation stability parameters (P1 and P2).ResultsAt baseline, the BCVA of the 14 eyes of 8 patients amounted 0.73 (± 0.23) LogMAR. Between timepoints, the BCVA increased in 3.21 letters (p = .021), the AV improved in 1.84 dB (p = .03, 9.73%), the CRT decreased in 24.43 µm (p = .007, − 4.05%), and the MV dropped in 0.27 µm3 (p = .016, − 2.68%). P1 and P2 did not variate. The collapse of the MCS led to the reduction of macula thickness. CRT at baseline correlated with the decrease of CRT (Spearman’s ρ: − 0.83 [p = .001]). Age and change of BCVA, CRT, and AV did not correlate among one another. Eyes with disrupted ellipsoid zone showed a more prominent change in CRT (p = .050). Photoreceptor outer segment length and integrity of the external limiting membrane and cone outer segment tips were not associated with BCVA, AT, or CRT variation.ConclusionEyes of treatment-naïve XLRS patients show diurnal macular thickness and function changes. Eyes with pronounced macular thickness show a greater reduction of the MCS. These results should be taken into consideration in upcoming clinical trials in XLRS.Trial registration numberInstitutional Review Board of the Hamburg Medical Chamber (Ethik-Kommission der Ärztekammer Hamburg): 2020–10,328.

Способ малоинвазивной транслокации организовавшегося субфовеального кровоизлияния

Purpose. To present a method of minimally invasive surgery, including two-port 27G surgery with controlled administration of a solution of recombinant prourokinase in a patient with organized submacular hemorrhage (SMH). Material and methods. A patient with SMH lasting for 30 days underwent a procedure developed on the basis of the N.I. Pirogov National Medical Surgical Center. It's a minimally invasive technique that includes a two-port 27G access without vitrectomy with controlled administration of a solution of recombinant prourokinase 500 ME through a 38G cannula subretinally, followed by tamponade of the vitreal cavity with a 20 % gasair mixture of hexafluoroethane C2F6. A standard ophthalmological examination was performed before the start of treatment, on the 1st day, 2 weeks later, 6 months after vitreoretinal intervention. Results. Visual acuity was 0.1 at the initial examination and 0.05 upon admission to the surgical hospital. Follow-up showed an increase in visual function to 0.3 at 1 month and to 0.5 at 6 months with antivasoproliferative therapy. According to optical coherence tomography at the initial examination, the central retinal thickness (CRT) was 642 µm, followed by a depression of up to 451 µm by the time of hospitalization. On the 14th day, the decrease in CRT reached 267 µm with complete translocation of the hemorrhage and 243 µm after 6 months. The height of detachment of the retinal pigment epithelium at the initial examination showed a value of 167 µm, and at subsequent observation it was 45 µm, 38 µm and 12 µm on the 1st, 14th day and after 6 months, respectively. Against the background of anatomical results, there was a decrease in the zone of absolute scotoma from 25 loci at the time of admission to 3 loci after 6 months, and an increase in total photosensitivity from 4.5 dB to 15.6 dB, respectively. Conclusion. The use of a minimally invasive method for the treatment of SMH, including subretinal administration of tissue plasminogen activator without vitrectomy with gas-air tamponade, improves morphological and functional prognosis. However, further study of the proposed technique on long-term hemorrhages is required. Keywords: submacular hemorrhage, tissue plasminogen activator, pneumodislocation

Малоинвазивное хирургическое лечение организовавшегося субмакулярного кровоизлияния

Purpose. To present a method of minimally invasive surgery, including two-port 27G surgery with controlled administration of a solution of recombinant prourokinase in a patient with organized submacular hemorrhage (SMH). Material and methods. A patient with SMC lasting 30 days underwent a procedure developed on the basis of the Center for Ophthalmology «N.M. N.I. Pirogov» is a minimally invasive technique that includes a two-port 27G access without vitreectomy with controlled administration of a solution of recombinant prourokinase 500 ME through a 38G cannula subretinally, followed by tamponade of the vitreal cavity with a 20% gas-air mixture of hexafluoroethane C2F6. A standard ophthalmological examination was performed before the start of treatment, on the 1st day, 2 weeks later, 6 months after vitreoretinal intervention. Results. Visual acuity was 0.1 at the initial examination and 0.05 upon admission to the surgical hospital. Follow-up showed an increase in visual function to 0.3 at 1 month and to 0.5 at 6 months with antivasoproliferative therapy. According to optical coherence tomography at the initial examination, the central retinal thickness (CRT) was 642 µm, followed by a depression of up to 451 µm by the time of hospitalization. On the 14th day, the decrease in CRT reached 267 µm with complete translocation of the hemorrhage and 243 µm after 6 months. The height of detachment of the retinal pigment epithelium at the initial examination showed a value of 167 µm, and at subsequent observation it was 45 µm, 38 µm and 12 µm on the 1st, 14th day and after 6 months, respectively. Against the background of anatomical results, there was a decrease in the zone of absolute scotoma from 25 loci at the time of admission to 3 loci after 6 months, and an increase in total photosensitivity from 4.5 dB to 15.6 dB, respectively. Conclusion. The use of a minimally invasive method for the treatment of SMH, including subretinal administration of tissue plasminogen activator without vitreectomy with gas-air tamponade, improves morphological and functional prognosis. However, further study of the proposed technique on long-term hemorrhages is required. Key words: submacular hemorrhage, tissue plasminogen activator, pneumodislocation

Efficacy and safety profile of intravitreal dexamethasone implant versus antivascular endothelial growth factor treatment in diabetic macular edema: a systematic review and meta-analysis

To better understand the efficacy of intravitreal dexamethasone implant (Ozurdex) versus antivascular endothelial growth factor (anti-VEGF) treatment in patients with diabetic macular edema (DME). A systematic review and meta-analysis. The study included randomized control trials (RCTs) and non-randomized control trials (Non-RCTs) before December 2021 that compare the efficacy of Ozurdex-related therapyand anti-VEGF therapy. We searched PubMed, Cochrane Library, and EMBASE. The quality of the included studies was assessed carefully. 30 studies were included. Regarding BCVA change, the overall result revealed no significant differences between Ozurdex and anti-VEGF therapies in patients with nonresistant DME, but Ozurdex group had significantly more VA improvement than anti-VEGF therapies in patients with resistant DME (MD 0.12, 95% CI 0.02–0.21). In terms of central retinal thickness (CRT) decrease, there was a significant difference between Ozurdex therapy and anti-VEGF therapy in patients with nonresistant DME (MD 48.10, 95% CI 19.06–77.13) and resistant DME (MD 65.37, 95% CI 3.62–127.13). Overall, Ozurdex therapy resulted in significantly greater VA improvement and CRT decrease than anti-VEGF therapy in resistant DME patients. Ozurdex therapy was not inferior to anti-VEGF therapy in patients with nonresistant DME.

Однолетние исходы лечения центральной серозной хориоретинопатии

Purpose. To study 1 year follow-up of central serous chorioretinopathy (CSC) based on the new multimodal imaging-based classification and identify the predictors for anatomic and visual outcome. Methods. Retrospective, study on 95 eyes diagnosed with CSCR and a follow up of at least 12 months were included. All eye received multimodal imaging, including color fundus photography, optical coherence tomography, and fundus autofluorescence. Results. At the baseline, observation was advised to 70 % eyes with simple CSCR whereas photodynamic therapy (PDT) was performed in 49 % eyes with complex CSCR. Over the follow up, decrease in central retinal thickness (CRT) was significantly higher in simple CSCR as compared to complex CSCR (P = 0.008) and the recurrences were significantly more in eyes with lower CRT at baseline (P = 0.0002). Multiple regression model showed baseline best corrected visual acuity (BCVA) and baseline SRF were significantly associated with final BCVA and SRF at one year (P &lt; 0.05). Conclusions. Complex CSCR more often required PDT and requires for longer time for SRF resolution. Baseline BCVA and SRF were associated with one-year outcomes. Keywords: central serous chorioretinopathy, classification, optical coherence tomography, multimodal imaging; retina

Влияние нутрицевтика на комплексную терапию неоваскулярной возрастной макулярной дегенерации на фоне применения анти-VEGF препарата афлиберцепт

Purpose. Evaluation of efficacy of aflibercept (Eylea®, Bayer, Germany) in combination with nutraceutical Ophtholique® (Sentiss Pharma, India) in treatment of neovascular agerelated macular degeneration (nAMD). Material and methods. 32 patients (32 eyes) with nAMD aged 54 to 75 years, controls – 12 healthy people of same age and gender. Initially, best-corrected visual acuity (BCVA) averaged 0.32±0.05. Clinical and morphological features of nAMD was macular neovascularization (MNV): in 18 patients – type 1; 14 people – type 2. All patients underwent 3 intravitreal injections of aflibercept. Two groups were formed, comparable in terms of BCVA and central retinal thickness (CRT), duration and severity of macular changes, gender, age: the main group (17 patients) – treatment was supplemented with Ophtholique®; comparison group (15 patients) – Ophtholique® was not prescribed. Results. After 1 month after 3 intravitreal injections of aflibercept, all 32 patients had no signs of disease activity. The interval between injections was increased according to the protocol by 2 weeks. After 6 months in the main group, the BCVA increased to 0.61 ± 0.02 due to regression of MNV, a decrease of CRT to control values was noted. In the comparison group, BCVA increased to 0.47 ± 0.03, CRT decreased to control values in 8 out of 15 patients. In 7 patients, BCVA, on the contrary, decreased to 0.30 ± 0.01, while the CRT increased to 421.5 ± 5.2 µm. By 12 months all patients of the main group showed none resumption of MNV activity, complete reattachment of neurosensory retina and pigment epithelium, resorption of intraretinal cystic cavities was noted. In the comparison group MNV activity was noted in 5 eyes with decrease in functional parameters of the retina. Conclusion. Combination of aflibercept in Tread-and-Extend treatment regimen with oral administration of nutraceutical Ophtholique® take it possible to increase efficacy of treatment of nAMD. Keywords: neovascular AMD, anti-VEGF therapy

Maximal Extension Interval and Visual Outcomes in a Treat-and-Extend Protocol: A Post Hoc Analysis of the CANTREAT Randomized Trial

Introduction: The Canadian Treat-and-Extend Analysis Trial with Ranibizumab (CANTREAT) was a 2-year, multicentred, randomized clinical trial to evaluate treat-and-extend (T&E) relative to monthly administration of ranibizumab in neovascular age-related macular degeneration (nAMD). This post hoc analysis of the CANTREAT trial explores the relationship between the maximal extension interval tolerated by patients receiving T&E ranibizumab and visual acuity outcomes. Methods: Treatment-naïve patients with nAMD were randomized to receive either a once-monthly dosing or T&E regimen of ranibizumab across 27 treatment centres in Canada and were followed for 24 months. For this post hoc analysis, patients in the T&E cohort were subdivided into the following groups based on maximum extension interval: 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks. The primary outcome was the change in ETDRS best-corrected visual acuity (BCVA) from baseline to month 24 while secondary outcomes included change in central retinal thickness (CRT). All results were reported using descriptive statistics. Results: A total of 285 participants undergoing T&E were enrolled in this post hoc analysis. At month 24, the change in BCVA from baseline was +8.5 ± 9.3, +7.7 ± 13.8, +4.4 ± 9.6, +4.4 ± 18.5, and +7.8 ± 14.8 letters in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively. The change in CRT at month 24 was −79.2 ± 95.0, −143.9 ± 128.9, −97.7 ± 101.1, −120.9 ± 105.3, and −133.2 ± 108.8 μm in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively. Conclusion: The capacity to extend does not necessarily associate with improved visual acuity outcomes, with the poorest change in BCVA seen in those extended 8–10 weeks. The highest change in BCVA and lowest decrease in CRT was in the group maximally extended for 4 weeks. There was a correlation between change in BCVA and change in CRT for other extension groups. Future studies should establish the predictive factors for successful extension in patients undergoing T&E in nAMD.

Short Term Outcomes of Switching to Brolucizumab for Neovascular Age-related Macular Degeneration Limited Response to Aflibercept

Purpose: To evaluate clinical outcomes of brolucizumab injection in neovascular age-related macular degeneration (nAMD) that shows limited response to aflibercept therapy.Methods: Retrospective review of medical records was performed for patients diagnosed with nAMD who underwent switching to brolucizumab due to limited response to aflibercept. Visual acuity (VA) and central retinal thickness (CRT) were compared between before switching, 1 month and 3 months after the switching. The proportion of patients exhibiting subretinal fluid (SRF) and intraretinal fluid (IRF) were identified. Development of intraocular inflammation was additionally evaluated.Results: Thirteen patients were included. The mean VA and CRT was 0.38 ± 0.20 and 379.7 ± 100.9 µm before the switching, 0.34 ± 0.19 and 262.2 ± 94.3 µm at 1 month, and 0.39 ± 0.24 and 322.9 ± 92.8 µm at 3 months. There was a significant decrease in CRT at 1 month after the switching (&lt;i&gt;p&lt;/i&gt; = 0.003). However, VA changes were not significant. The proportion of patients showing SRF and IRF was 100% and 23.1% before the switching, 30.8% and 7.7% at 1 month, and 69.2% and 30.8% at 3 months. Retinal vasculitis developed in one patient (7.7%). The inflammation was resolved after steroid treatment.Conclusions: Despite the inherent limitations posed by the small sample size, this study represents the first domestic report evaluating the outcomes of switching to brolucizumab. Brolucizumab injection was found to be a useful alternative treatment for short-term resolution of retinal edema in nAMD showing limited response to aflibercept. However, the risk of intraocular inflammation should be considered.

Treatment of Non-Infectious Posterior Uveitis with Dexamethasone Intravitreal Implants in a Real-World Setting.

The present study aimed to assess the efficacy and safety associated to the treatment of patients with non-infectious posterior uveitis with intravitreal dexamethasone (DEX) implants in a real-world clinical setting. This is a retrospective, single center analysis of the data from 29 patients with non-infectious posterior uveitis in whom 38 eyes were treated with dexamethasone intravitreal implants in routine clinical practice between January 2012 and October 2017. The parameters of visual acuity (VA), intraocular pressure (IOP) and central retinal thickness (CRT) were recorded 6 weeks after the first implant was administered, in accordance with the clinical guidelines for the use of these implants, and after a 6-month follow-up period. In addition, the formation of cataracts was evaluated at 12 months. Treatment with the DEX implant caused a significant improvement in the VA from baseline at 6 weeks in eyes treated with 2-6 implants and for eyes without cataracts. A significant decrease in CRT was observed relative to the baseline at 6 weeks for eyes treated with 1 and 2-6 implants, which was maintained at 6 months for those eyes treated with 2-6 implants. This significant improvement in CRT at 6 weeks and 6 months was evident in eyes with and without cataracts. During the study period, the IOP was found to increase significantly from baseline at 6 weeks in some eyes but this was managed topically, and no surgical intervention was necessary. Intravitreal DEX implants represent an effective and safe therapy for the treatment of non-infectious uveitis in routine clinical practice, producing favorable visual and anatomical outcomes after the administration of just 2-6 DEX implants.

[Faricimab: from research to clinical practice].

Development of new molecules for anti-angiogenic therapy pursues the following objectives: to increase the interval between injections, which can reduce the treatment burden; to improve the effectiveness of treatment by affecting various links of pathogenesis; to ensure a good safety profile. Faricimab is a humanized immunoglobulin G antibody that targets two key angiogenesis sites: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). In the STAIRWAY clinical trial, faricimab was shown to produce similar results to monthly ranibizumab at longer intervals and fewer intravitreal injections in patients with neovascular age-related macular degeneration, specifically in terms of visual preservation and reduction in central retinal thickness (CRT). In the BOULEVARD trial, which lasted 36 weeks, the severity of diabetic retinopathy according to DRSS improved in previously untreated patients with diabetic macular edema by two stages and more in 12.2% of the 0.3 mg ranibizumab group, in 27.7% of patients in the 1.5 mg faricimab group, and in 38.6% of patients in the group treated with 6.0 mg faricimab. In the TENAYA, as well as LUCERNE, YOSEMITE and RHINE trials, the increase in best-corrected visual acuity (BCVA) from baseline in the faricimab group was comparable to that in the aflibercept group. Real clinical practice showed an increase in BCVA from 59.5 to 60.6 letters (p=0.035) due to a decrease in CRT from 334.3 to 303.3 µm (p=0.001). The first published studies are now appearing, and their results correspond to the clinical trials, which indicates a stable effect of the drug and the prospects for use in a large cohort of patients.

[Short-term experience of intravitreal brolucizumab in treatment of diabetic macular edema].

This study examines the efficacy and safety of brolucizumab in the treatment of diabetic macular edema (DME) in real clinical practice in the Russian Federation. The study included 14 consecutive treatment-naïve DME patients, among them 7 males and 7 females (21 eyes in total) with mean age of 65.1±8.0 years. Patients underwent standard ophthalmological examination and multimodal imaging, including optical coherence tomography. All patients received intravitreal injections of brolucizumab every 6 weeks. A total of 73 injections were performed. A data analysis was performed for 10 eyes of 10 patients 6 months after initiation of the treatment. After 4 injections of brolucizumab, best-corrected visual acuity (BCVA) increased statistically significantly from 35.8±13.7 to 41.5±11.9 ETDRS letters (p=0.03), central retinal thickness (CRT) and macular volume (MV) decreased from 411.5±107.4 to 280.2±64.6 microns (p=0.014) and from 7.39±0.92 to 6.16±7.37 mm3 (p=0.0006), respectively. The average gain of visual acuity was 5.7±7.0 letters, average decrease of CRT was -131.3±91.2, and average decrease of MV was -1.21±0.75 mm3. There were no adverse events associated with intraocular inflammation. Intravitreal injections of brolucizumab provide significant anatomical and functional improvement to DME patients in real clinical practice with results comparable to that of randomized clinical trials.

Comparison of intravitreal ranibizumab, aflibercept and bevacizumab therapies in diabetic macular edema with serous retinal detachment.

To compare the effects of ranibizumab, aflibercept and bevacizumab treatments in treatment-naive diabetic macular edema(DME) patients with serous retinal detachment(SRD). This is a retrospective, comparative study. In a sample of 86 eyes of 86 untreated DME patients with accompanying SRD, 23 patients were treated with ranibizumab (IVR), 28 patients with aflibercept (IVA), and 35 patients with bevacizumab (IVB). All were injected intravitreally once a month for a 3-month loading dose. Subsequently, all participants were evaluated every months and if neccessary they received additional intravitreal treatments.Mean changes in best corrected visual acuity (BCVA), central retinal thickness (CRT), and SRD height over the 6-months study period were compared. At baseline, the groups did not differ in mean BCVA,CRT and SRD height. During the first 3 months, in IVA group the mean decrease in CRT and SRD height were significantly more than in the other two groups (p < 0.05 for all). However, these differences disappeared at 6 months.The number of injections was similar between the groups during the study period. In patients with DME accompanied by SRD, IVA is a more advantageous option in terms of reduction in CRT and SRD height from baseline to 3 months. In the 6-month period of treatment, IVR, IVA and IVB therapies areanatomically and functionally similar and significant effective modalities.

Early anatomical changes and association with photodynamic therapy induced acute exudative maculopathy in patients with macular diseases

The purpose of this study was to investigate the occurrence rate and predictors of photodynamic therapy (PDT) induced acute exudative maculopathy (PAEM). This retrospective study included 39 eyes of 39 patients (32 males and 7 females), who were treated with initial PDT. PAEM was defined as an increase in central retinal thickness (CRT) of 15% or more measured by OCT on day 3 after PDT compared with baseline. Sixteen of 39 eyes (41%) were classified in the PAEM+ group. CRT and central choroidal thickness (CCT) were significantly increased at 3 days in the PAEM+ group and significantly decreased at 1 month after PDT in the PAEM- group. In a multiple comparison, neovascular age-related macular degeneration (nAMD) had a significantly higher incidence of PAEM compared to polypoidal choroidal vasculopathy (PCV) and central serous chorioretinopathy (CSC). The incidence of PAEM was lower in PCV and CSC, and higher in nAMD. BCVA at 1 month was significantly worse in the PAEM group, which may be related to visual prognosis after PDT. Since both CRT and CCT decrease at 1 month, the detection of PAEM needs to be assessed a few days after PDT.