Change In Best-corrected Visual Acuity Research Articles

Evaluation of the effect of vitreomacular interface disorders on anti-VEGF treatment in patients with diabetic macular edema in real life: MARMASIA study group report No. 10.

The aim of this study is to investigate the effect of vitreomacular interface disorders (VMID) on treatment response in patients treated with anti-vascular endothelial growth factor (anti-VEGF) due to diabetic macular edema (DME). Three hundred seventy-seven eyes of 239 patients in the MARMASIA Study Group who received intravitreal anti-VEGF treatment (IVT) due to DME were included in the study. The group 1 consisted of 44 eyes of the patients who had not received any treatment before, were followed up regularly for 24months after at least a 3-month loading dose, and suffered from VMID such as epiretinal membrane, vitreomacular adhesion or traction, and lamellar hole. The group 2 consisted of 333 eyes of the patients without VMID. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) of the patients at baseline, 3rd month, 6th month, 1st year and 2nd year follow-ups were measured. The mean age of the Groups 1 and 2 was 67.1 ± 11.3 and 61.9 ± 10.2 years, respectively. 61.3% of the group 1 and 58.8% of the group 2 were female (p > 0.05). The duration of diabetes was 19.2 ± 3.7 and 15.8 ± 3.2 years, respectively, and the number of follow-ups was 16.09 ± 4.68 and 12.06 ± 4.58, respectively in the groups (p < 0.001, 0.001, respectively). The number of IVT was 7.13 ± 2.71 and 7.20 ± 2.22, respectively in the groups 1 and 2 and no statistically significant difference was observed between them (p = 0.860). According to logMAR, BCVA values at baseline were 0.63 ± 0.24 and 0.59 ± 0.26 (p = 0.29), respectively, in the groups and the amount of change in BCVA at the end of the 2nd year was -0.02 ± 0.48 in the group 1 and -0.12 ± 0.48 in the group 2. It was observed as 0.48 (p = 0.13). Although the increase in BCVA was greater at all follow-ups in the group 2 compared to their initial examination, no significant difference was observed between the groups in terms of BCVA change. The CMT values of the groups at baseline were 442.5 ± 131.3µm and 590.9 ± 170.6µm, respectively (p = 0.03) The decrease in CMT after IVT was significantly greater in the group 2 at all follow-ups when compared to the first group (p < 0.05). While the presence of VMID in DME patients receiving IVT did not affect visual results, it negatively affected the anatomical response and macular edema morphology. The presence of VMID at baseline affected the success of IVT. It should be taken into consideration that VMID may resolve spontaneously or with IVT, and new cases of VMID may occur in patients during the treatment process.

Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration.

Photobiomodulation (PBM) has become a promising approach for slowing the progression of early and intermediate dry age-related macular degeneration (dAMD) to advanced AMD. This technique uses light to penetrate tissues and activate molecules that influence biochemical reactions and cellular metabolism. This preliminary analysis is aimed at assessing the safety, tolerability, and short-term effectiveness of the EYE-LIGHT®PBM treatment device in patients with dAMD. The EYE-LIGHT® device employs two wavelengths, 590nm (yellow) and 630nm (red), in both continuous and pulsed modes. Patients over 50years of age with a diagnosis of dAMD in any AREDS (Age-Related Eye Disease Study) category were randomly assigned to either the treatment group or the sham group. The treatment plan consisted of an initial cycle of two sessions per week for 4weeks. Safety, tolerability, and compliance outcomes, along with functional and anatomical outcomes, were assessed at the end of the fourth month. This preliminary analysis included data from 76 patients (152 eyes). All patients were fully compliant with treatment sessions, and only one fifth of patients treated with PBM reported mild ocular adverse events, highlighting exceptional results in terms of tolerability and adherence. Changes in best-corrected visual acuity (BCVA) from baseline to month 4 differed significantly between the sham and PBM-treated groups, favoring the latter, with a higher proportion achieving a gain of five or more letters post-treatment (8.9% vs. 20.3%, respectively; p = 0.043). No significant differences in central subfield thickness (CST) were observed between the two groups over the 4-month period. The study also found a statistically significant disparity in mean drusen volume changes from baseline to month 4 between the groups in favor of patients treated with PBM (p = 0.013). These preliminary results indicate that PBM treatment using the EYE-LIGHT® system is safe and well tolerated among patients with dAMD. Furthermore, both functional and anatomical data support the treatment's short-term efficacy. ClinicalTrials.gov identifier NCT06046118.

Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema

Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME). To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME. This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021. Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52. The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of -3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs). A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, -1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was -112 (7) μm vs -124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, -3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms. MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept. ClinicalTrials.gov Identifier: NCT03610646.

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-Week Results From the Phase 3 Mylight Study.

The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]). Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity score from baseline to Week 8. Secondary endpoints included anatomical outcomes, best-corrected visual acuity at Weeks 24 and 52, safety, and pharmacokinetics. Similarity in mean change in best-corrected visual acuity score was established between SDZ-AFL (n = 235) and Ref-AFL (n = 226) at Week 8 (difference: -0.3 [90% CI, -1.5 to 1.0]) and Week 52. No clinically meaningful differences occurred between groups in anatomical outcomes. Safety profiles were similar, with comparable incidences of treatment-related adverse events (SDZ-AFL: 2.5%; Ref-AFL: 2.9%). The incidence of anti-drug antibodies was similar between groups. Systemic free aflibercept concentrations 24 hours postdose were low and comparable between SDZ-AFL and Ref-AFL. Proposed biosimilar aflibercept matched reference aflibercept in efficacy, safety, and pharmacokinetics in participants with neovascular age-related macular degeneration. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL.

SEQUENTIAL PARS PLANA VITRECTOMY AND INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR RHEGMATOGENOUS RETINAL DETACHMENTS WITH PERIPHERAL BREAKS AND CONCOMITANT NONCAUSATIVE MACULAR HOLE IN NONHIGHLY MYOPIC PATIENTS.

To present the anatomical and functional results of sequential pars plana vitrectomy for treating rhegmatogenous retinal detachment with peripheral breaks and concomitant noncausative macular holes (MHs) in nonhighly myopic patients. Medical records of patients who underwent rhegmatogenous retinal detachment surgical repair between 2017 and 2023 were reviewed. Of 980 patients with rhegmatogenous retinal detachment, 10 had concurrent MH and underwent sequential pars plana vitrectomy for rhegmatogenous retinal detachment repair and air endotamponade, followed by MH repair using the inverted internal limiting membrane flap technique and C2F6 endotamponade after a minimum of 1 week. The main outcomes measured were best-corrected visual acuity change, retinal reattachment rate, MH closure rate, and closure type. The retinal reattachment rate was 90% after the primary surgery and 100% after subsequent surgery. Macular hole closure was achieved in all cases. Macular hole diameters ranged from 291 to 702 µm. Anatomical recovery showed mainly 1A closure types (90%). Functional recovery demonstrated significant best-corrected visual acuity improvement, with a mean visual acuity gain of 1.58 ± 0.41 the logarithm of the minimum angle of resolution. For this infrequent pathology, sequential surgery using the inverted internal limiting membrane flap technique and air/gas endotamponade yielded favorable anatomical and functional outcomes. This controlled and standardized approach using sequential surgeries contributes to the achievement of consistent results.

Two-year efficacy and safety of different anti-vascular endothelial growth factor regimens for neovascular age-related macular degeneration: a network meta-analysis of randomized controlled trials.

To compare the 2-year efficacy and safety of various anti-vascular endothelial growth factor (VEGF) regimens for neovascular age-related macular degeneration (nAMD). A comprehensive search was performed on multiple electronic databases up to April 2023 and updated in June 2024, to identify relevant randomized controlled trials (RCTs). Key outcomes included the proportion of patients achieving a vision gain of ≥15 letters and maintaining stable vision (loss of <15 letters) in best-corrected visual acuity (BCVA), changes in mean BCVA from baseline, serious ocular adverse events (SAEs), adverse events leading to treatment discontinuation and any cause of death at 2 years. Nineteen trials with 12,654 patients and 25 treatment regimens were analyzed in the study. All anti-VEGF regimens showed superior efficacy compared to sham therapy. Specifically, faricimab 6 mg (4+up to Q16W) and ranibizumab 0.5 mg (2-week T&E) displayed top-level effect in vision gain. Bevacizumab 1.25 mg (2-week T&E) and aflibercept 2 mg (2-week T&E) demonstrated the most stable vision outcomes. Bevacizumab 1.25 mg (2-week T&E) and ranibizumab 0.5 mg (2-week T&E) exhibited the most pronounced mean BCVA improvement. Compared to sham therapy, the risk of SAEs was significantly higher for brolucizumab 6 mg (3 + Q12W/ Q8W) (RR = 6.04, 95% CI: 1.30-28.02) and PDS 100 mg/ml (Q24W) (RR = 10.95, 95% CI: 2.14-56.02), but not for other anti-VEGF regimens. Ranibizumab 0.5 mg (2-week T&E) emerges as a potentially optimal regimen for nAMD over a 2-year period. Future studies need to consider the impact of baseline characteristics on treatment outcomes.

Efficacy and Durability of Faricimab in Naïve Eyes with Neovascular Age-Related Macular Degeneration

Introduction: The aim of the study was to evaluate functional and anatomical changes in patients with neovascular age-related macular degeneration (nAMD) treated with a loading dose of faricimab intravitreal injections (IVIs). Methods: Eighteen eyes of 18 patients with active macular neovascularization and nAMD were enrolled at the Ophthalmology Clinic of University G. D’Annunzio, Chieti-Pescara, Italy. All patients were scheduled for faricimab IVI as per label. Enrolled patients underwent complete ophthalmic evaluation, including optical coherence tomography, fluorescein angiography, and indocyanine green angiography. All measurements were evaluated at baseline (T0) and then monthly up to week 20 (T4). Main outcome measures were changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), subfoveal choroidal thickness (SFCT), pigment epithelial detachments (PEDs) presence and maximum height (PED-MH), intraretinal fluid (IRF) presence, subfoveal subretinal fluid (SSRF) presence and thickness. Results: BCVA improved and CMT reduced significantly during follow-up (p < 0.001). In addition, SFCT decreased significantly (p = 0.031). Between T0 and T4, SSRF presence reduced from 55.6 to 16.7% (p = 0.045); IRF presence changed from 50 to 22.2%, respectively (p = 0.074). PED-MH was reduced in 58.8% of patients at T4. At week 20, 72.3% of patients were in the q12/q16 interval. Conclusion: Faricimab showed efficacy in the treatment of naïve nAMD patients with an improvement of anatomical and functional parameters and a treatment interval after the loading phase equal or greater than 12 weeks in the majority of patients.

Treatment of Corneal Dermoid with Fibrin Glue Boned Multi-Layer Lenticules from Small Incision Lenticules Extraction Surgery: A Preliminary Study of Five Patients

Purpose Dermoid excision combined with lamellar keratoplasty was one of the most common surgical techniques for corneal dermoid. Due to the huge shortage of corneal donors, small incision lenticule extraction (SMILE) derived lenticules might be the novel and feasible corneal grafts instead of traditional corneal donors. Therefore, we tried to use FG boned multi-layer lenticules as grafts in the treatment of corneal dermoid. Methods Five patients (the oldest patient was 54 years old and the youngest case was 5 years old) were diagnosed with corneal dermoid and complaining of blurred vision or unsatisfied cosmetic appearance. All patients underwent corneal dermoid excision combined with FG boned multi-layer corneal lenticules transplantation. Slit-lamp microscopy and anterior-segmental optical coherence tomography(AS-OCT)were used to observe ocular appearance, corneal grafts survival, epithelialization, transparency, interlamellar fluid accumulation and the degradation of FG. The preoperative and postoperative change of best-corrected visual acuity (BCVA) and astigmatism were respectively recorded. Results All patients were satisfied with the postoperative cosmetic results. BCVA had been increased and astigmatism had been decreased in all cases. We observed that the FG boned multi-layer corneal lenticules were covered with smooth corneal epithelium in one week after transplantation and successfully adhered to the corneal beds, without any dislocation or interlayer separation. FG was gradually degraded and absorbed within 1 month after surgery. The lenticule grafts grew well without rejection and kept transparency during the follow-up period. Conclusions FG boned multi-layer lenticules would be the novel and feasible substitute for lamellar keratoplasty in the treatment of corneal dermoid. FG could not be only used as binder adhering multi-layer lenticules, closing the interlayer space of multi-layer lenticules, preventing the formation of interlayer fluid, but also increasing the thickness and toughness of lenticules, and therefore which is more facilitate to intraoperative suture.

Medical Therapy for Large Idiopathic Full-Thickness Macular Holes.

To describe the characteristics and outcomes of eyes with idiopathic full-thickness macular holes (FTMH) that underwent initial medical management. This retrospective study included eyes with FTMH that were initially managed with one month of topical therapy. Eligible subjects were treated with dorzolamide 2% three times a day, nepafenac 0.1% twice a day, and prednisolone acetate 1% four times a day. The primary endpoints was hole closure at one month and secondary endpoint was change in best-corrected visual acuity (BCVA). Ten subjects (mean age: 62.80 years; female: 50%) with unilateral FTMH were studied. The mean basal diameter of the entire cohort at baseline was 824.1 µm (median 828 µm). Four (40%) of the smaller holes (mean 698 µm; median 698.50 µm) closed after one month of topical therapy, whereas larger holes (mean 908.17µm; median 889.50 µm) did not close. In one eye, the hole reopened 4 months after stopping the medication, but closed again at one month after re-starting the topical treatment. Median BCVA improved from 0.35 logMAR at baseline to 0.05 logMAR in eyes that closed but remained at 0.70 logMAR at one month in eyes that did not close. Topical corticosteroid, non-steroidal anti-inflammatory, and carbonic anhydrase inhibitor therapy may promote closure of small FTMHs, but large holes are less likely to respond. One month of topical therapy might avoid subjecting some patients to complex vitreo-retinal surgery without compromising visual outcomes. Macular hole may re-open after stopping the topical therapy.

SURGICAL OUTCOMES IN CONCURRENT SICKLE CELL AND DIABETIC RETINOPATHY.

To report the clinical features and outcomes in eyes that underwent vitreoretinal surgery for complications of concurrent sickle cell retinopathy and diabetic retinopathy. Retrospective, consecutive case series of all eyes that underwent vitreoretinal surgery for complications secondary to concurrent sickle cell retinopathy and diabetic retinopathy between January 01, 2014, and December 31, 2021. The study included 20 eyes of 14 patients. Indications for surgery included tractional retinal detachment in 12 eyes (60%), combined tractional retinal detachment/rhegmatogenous retinal detachment in 6 eyes (30%), and vitreous hemorrhage in 2 eyes (10%). Pars plana vitrectomy was performed in all eyes. One eye received a scleral buckle at the same time as pars plana vitrectomy. There was no change in mean best-corrected visual acuity at the last follow-up examination (1.5 [20/678]) when compared with mean preoperative best-corrected visual acuity (1.6 [20/762], P = 0.83). Preoperative best-corrected visual acuity correlated with postoperative best-corrected visual acuity at the last follow-up examination in eyes with retinal detachment (r = 0.49, P = 0.04). Single operation anatomic success was achieved in 11 of 17 eyes (65%) with retinal detachment. Functional and anatomic outcomes after surgery in eyes with concurrent sickle cell retinopathy and diabetic retinopathy are relatively poor.

The Short-Term Efficacy and Safety of Faricimab in Refractory Neovascular Age-Related Macular Degeneration: The Real-World Experience in Taiwan

Introduction: Anti-vascular endothelial growth factor (VEGF) treatment stands as the primary approach for neovascular age-related macular degeneration (nAMD). Faricimab has recently emerged as a novel anti-VEGF option for nAMD. This study aimed to assess the efficacy of faricimab in patients with refractory nAMD. Method: This retrospective study focused on refractory nAMD patients treated with faricimab at Taipei Veterans General Hospital from March 2023 to December 2023. Primary outcomes assessed the change in mean best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over the first 4 months. Secondary outcomes included the presence of subretinal and intraretinal fluid (SRF and IRF) and changes in pigment epithelial detachment (PED). Subgroup analysis for the successful and unsuccessful treatment groups was conducted to identify potential confounding factors influencing treatment response. Result: This study included 42 eyes with refractory nAMD treated with faricimab. During a 6-month follow-up, no significant improvement in BCVA was observed, while CRT significantly decreased at all time points, except during the 5-month follow-up. Height PED showed significant reduction up to 5 months. The prevalence of SRF decreased significantly, while IRF remained lower but not significant. According to the treatment criteria, 67.4% successfully met the treatment goals. Subgroup analysis between successful and unsuccessful groups showed no significant differences in baseline characteristics, except a higher predominantly serous PED percentage in the successful group. Conclusion: Faricimab showed favorable outcomes in refractory nAMD patients. Further investigations are needed to understand the factors contributing to its efficacy.

Aflibercept for central retinal vein occlusions: long-term outcomes of a ‘Treat-and-Extend’ regimen

Background/aimsThis study reports on the long-term functional and anatomical outcomes of patients with central retinal vein occlusion (CRVO) treated under the Bern treat-and-extend (T&E) protocol.MethodsObservational study. Treatment-naive patients with CRVO...

Vitrectomy in Small idiopathic MAcuLar hoLe (SMALL) study: conventional internal limiting membrane peeling versus inverted flap.

To compare conventional internal limiting membrane (ILM) peeling versus inverted flap technique in small idiopathic macular hole. Retrospective, multicentre cohort study including consecutive eyes with a ≤250 μm idiopathic macular hole treated with primary vitrectomy. The primary outcome was best-corrected visual acuity (BCVA) change and macular hole closure rate. Closure patterns on optical coherence tomography (OCT) and rates of external limiting membrane (ELM) and ellipsoid zone (EZ) recovery were considered as secondary outcomes. A total of 389 and 250 eyes were included in the conventional ILM peeling group and in the inverted flap group, respectively. Hole closure rate was comparable between the two groups (98.5% in the ILM peeling group and 97.6% in the inverted flap group). Mean BCVA was comparable between the two groups at baseline (p = 0.331). At 12 months, mean BCVA was 0.14 ± 0.19 logMAR in the conventional ILM peeling group and 0.17 ± 0.18 logMAR in the inverted flap group (p = 0.08). At 12 months, 73% of eyes had a U-shape closure morphology in the conventional ILM peeling group versus 55% in the inverted flap group. At 12 months, ELM recovery rate was 96% and 86% in the conventional ILM peeling group and in the inverted flap group, respectively (p < 0.001); EZ recovery rate was 78% and 69%, respectively (p = 0.04). The inverted flap technique provides no advantages in terms of visual outcome and closure rate in small idiopathic macular hole surgery. Additionally, this technique seems to impair postoperative restoration of external retinal layers compared with conventional peeling.

Comparison of the effects of 0.05% topical cyclosporine A versus 0.1% topical cyclosporine A on recurrence and clinical parameters following pterygium surgery.

To compare the efficacy of topical 0.05% cyclosporine A (CsA) and 0.1% topical cyclosporine A (CsA) over a 6-month period following pterygium surgery, specifically evaluating their effects on postoperative recurrence and clinical parameters. This clinical study enrolled 245 patients with pterygium who underwent surgery using the conjunctival autograft technique with mitomycin C (MMC) were enrolled. Participants were divided into three groups: Group 1 (0.05% CsA) (n = 80), Group 2 (0.1% CsA) (n = 80), and a control group (n = 85). They were examined at postoperative first day, first week, first month and sixth month. The examination included best corrected visual acuity (BCVA), intraocular pressure (IOP), presence of inflammation, and ptergium recurrence, all of which were compared across the groups. The mean age of the patients was 63.22 ± 9.39 years, with 53.3% male and 46.7% female. The three groups were similar in terms of demographic characteristics and pterygium size. Inflammation in surgical area significantly regressed in all groups at 6 months postoperatively (p < 0.05). Inflammation in the first and sixth months was not different between the groups (p = 0.118, p = 0.580, and p = 0.435, respectively). The recurrence rate was not different between groups (p = 0.890). There was no statistically significant difference between groups regarding IOP (p = 0.818). A significant increase in BCVA after surgery was observed in three groups compared to preoperative levels (p < 0.05). This study showed that there was no difference between the efficacy of 6 month topical 0.05% CsA and 0.1% CsA application after pterygium surgery with the conjunctival autograft technique with MMC on postoperative outcomes. Including postoperative recurrence, IOP changes, BCVA changes and surgical area inflammation.

Pigmented paravenous retinochoroidal atrophy and retinitis pigmentosa-like phenotype in the same patient: A case series.

Concomitant manifestation of PPRCA in one eye and RP-like retinopathy in the fellow eye is a rare clinical entity, with limited published descriptions to date. The aim of this study is to describe comprehensive clinical evaluations and long-term follow-up of three patients affected by this clinical picture. Three patients with concurrent PPRCA and RP-like retinopathy were prospectively re-evaluated and comprehensive assessments were performed. The progression of disease was assessed by comparing best corrected visual acuity (BCVA) and ellipsoid zone (EZ) width with data available from each patient's medical charts and previous SD-OCT scans. Blood samples were collected and tested to rule out autoimmune or infectious ocular diseases, for testing anti-retinal autoantibodies (ARAs) and for genetic analysis. Reduction in BCVA and a progressive concentric loss of the EZ band over time were detected in the eye with RP-like phenotype in all three patients, while in the eye with PPRCA none of the patients showed significant changes in BCVA and only one patient showed a progressive reduction of the EZ width. No clear etiology has been identified. Two or more ARAs subtypes were detected in two out of three patients. PPRCA was demonstrated to be a non-progressive or slowly progressive disease, instead the eye with RP-like phenotype showed a progressive visual impairment, highlighting the importance of shedding light on this condition. Its etiology remains unclear: a genetic trait with different phenotype between the two eyes is conceivable, as well as a potential role of ARAs.

Short-term Outcomes of Faricimab for Neovascular Age-related Macular Degeneration with Limited Response to Ranibizumab or Aflibercept

Purpose: To evaluate the clinical outcomes of switching to faricimab for patients with neovascular age-related macular degeneration (AMD) demonstrating a limited response to prior anti-vascular endothelial growth factor (VEGF) treatments.Methods: We performed a retrospective analysis of patients with neovascular AMD who had residual subretinal fluid (SRF) or intraretinal fluid (IRF) despite treatment with ranibizumab or aflibercept, and who were subsequently treated with faricimab. The study assessed changes in best-corrected visual acuity (logarithm of the minimum angle of resolution) and central retinal thickness (CRT), as well as differences in the incidence of SRF, IRF, and serous retinal pigment epithelial detachment (S-PED) with versus without switching to faricimab.Results: The study included 22 eyes. Mean best-corrected visual acuity improved from 0.31 ± 0.21 before switching to faricimab to 0.28 ± 0.19 after the switch (&lt;i&gt;p&lt;/i&gt; = 0.172). CRT significantly decreased from 336.7 ± 83.3 to 279.9 ± 51.1 μm (&lt;i&gt;p&lt;/i&gt; = 0.002). Prior to switching, SRF was noted in 17 patients (94.4%), IRF in 5 (27.8%), and S-PED in 4 (22.2%). Following the switch to faricimab, these figures dropped to 13 (72.2%), 4 (22.2%), and 3 (16.7%), respectively. A complete resolution of retinal edema was achieved in four patients (22.2%) after the treatment switch.Conclusions: Switching to faricimab in patients with neovascular AMD who had a limited response to previous treatments led to significant anatomical improvements. Faricimab may be a valuable treatment option for these patients.

Vitrectomy as an Adjunct to Treat-and-Extend Anti-VEGF Injections for Diabetic Macular Edema

There are reported benefits from vitrectomy for diabetic macular edema (DME); however, data precede anti-vascular endothelial growth therapy (VEGF) therapy, supporting a need to assess the current role of vitrectomy. To determine rates of recruitment and efficacy outcomes of vitrectomy plus internal limiting membrane (ILM) peeling adjunctive to treat-and-extend (T&E) anti-VEGF injections for diabetic macular edema (DME). This was a single-masked, multicenter randomized clinical trial at 21 sites in the United Kingdom from June 2018 to January 2021, evaluating single eyes of treatment-naive patients with symptomatic vision loss from DME for less than 1 year. Inclusion criteria were best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score greater than 35 (approximate Snellen equivalent, 20/200 or better) and central subfield thickness (CST) greater than 350 μm after 3 monthly intravitreal injections of ranibizumab or aflibercept. Data analysis was performed in July 2023. Patients were randomized 1:1 into vitrectomy plus standard care or standard care alone and further stratified into groups with vs without vitreomacular interface abnormality. Both groups received a T&E anti-VEGF injection regimen with aflibercept, 2 mg, or ranibizumab, 0.5 mg. The vitrectomy group additionally underwent pars plana vitrectomy with epiretinal membrane or ILM peel within 1 month of randomization. Rate of recruitment and distance BCVA. Secondary outcome measures were CST, change in BCVA and CST, number of injections, rate of completed follow-up, and withdrawal rate. Over 32 months, 47 of a planned 100 patients were enrolled; 42 (89%; mean [SD] age, 63 [11] years; 26 [62%] male) completed 12-month follow-up visits. Baseline characteristics appeared comparable between the control (n = 23; mean [SD] age, 66 [10] years) and vitrectomy (n = 24; mean [SD] age, 62 [12] years) groups. No difference in 12-month BCVA was noted between groups, with a 12-month median (IQR) BCVA letter score of 73 (65-77) letters (Snellen equivalent, 20/40) in the control group vs 77 (67-81) letters (Snellen equivalent, 20/32) in the vitrectomy group (difference, 4 letters; 95% CI, -8 to 2; P = .24). There was no difference in BCVA change from baseline (median [IQR], -1 [-3 to 2] letters for the control group vs -2 [-8 to 2] letters for the vitrectomy group; difference, 1 letter; 95% CI, -5 to 7; P = .85). No difference was found in CST changes (median [IQR], -94 [-122 to 9] μm for the control group vs -32 [-48 to 25] μm for the vitrectomy group; difference, 62 μm; 95% CI, -110 to 11; P = .11). Enrollment goals could not be attained. However, with 47 participants, evidence did not support a clinical benefit of vitrectomy plus ILM peeling as an adjunct to a T&E regimen of anti-VEGF therapy for DME. isrctn.org Identifier: ISRCTN59902040.

One-Year Outcome of Intravitreal Injection of Ranibizumab Biosimilar for Myopic Choroidal Neovascularization in Japanese Patients.

Objectives: To evaluate the one-year outcomes of intravitreal ranibizumab biosimilar (RBZ-BS) injections for myopic choroidal neovascularization (mCNV) in Japanese patients. Methods: Twenty-one patients (mean age 69.0 years; 4 males, 17 females) with high myopia and mCNV were retrospectively reviewed. Twelve were treatment-naïve, and nine had previous anti-VEGF treatments. Efficacy measures included best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: The treatment-naïve group showed significant BCVA improvement from 0.55 ± 0.34 at baseline to 0.24 ± 0.28 at 12 months. The previously treated group had no significant BCVA changes. CMT significantly decreased in both groups: from 295.3 ± 105.2 µm to 207.3 ± 63.0 µm in the treatment-naïve group, and from 196.1 ± 62.0 µm to 147.2 ± 50.1 µm in the previously treated group. Dry macula rates were high: 83% at 3 months and 83% at 12 months in the treatment-naïve group, and 67% at 3 months and 89% at 12 months in the previously treated group. No adverse events were reported. Conclusions: These findings indicate that RBZ-BS is an effective and safe treatment for mCNV, particularly in treatment-naïve patients. The use of RBZ-BS offers a cost-effective alternative to original ranibizumab, reducing financial burdens while maintaining high therapeutic efficacy. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and evaluate long-term outcomes and cost-effectiveness.

Xen gel stent implant for persistent glaucoma after silicone oil removal.

To evaluate the effectiveness and safety of the XEN-Stent for managing unresponsive to medical therapy secondary glaucoma after silicone oil (SO) removal. This retrospective chart reviewed 12 patients who underwent vitrectomy and SO endotamponade. They experienced intraocular pressure (IOP) elevation after SO removal despite taking the maximum tolerated glaucoma medication. Eleven eyes underwent an XEN-implant, while 1 underwent an XEN-implant with phacoemulsification/IOL implantation. The primary outcome was to achieve success criteria: IOP <18 mmHg and >20% IOP reduction without medication (complete success) or with medication (qualified success) and without a secondary IOP-lowering procedure. IOP, best-corrected visual acuity (BCVA), and the number of glaucoma medications (Glaucoma Medication Score-GMS) were recorded at baseline, 1 day, 1 week, 1 (M1), 3 (M3), 6 (M6), and 12 (M12) months postoperatively. Baseline characteristics included males percentage 66.6%, mean age of 61.8 ± 5.7 years, BCVA 0.69 ± 0.3 logMAR, IOP 30 ± 4.2 mmHg, and GMS 3.1 ± 0.5. There was a significant reduction in IOP by 14 ± 1.9 mmHg and GMS by 0.27 ± 0.6 at M12 compared to baseline (p < 0.01), but no significant change in BCVA (p = 0.21). Complete success dropped to 50% (M3), rising to 75% (M6, M12) after needling. Two patients achieved qualified success at M12. Needling was performed in 6 eyes, with 3 requiring a second procedure. Ex-PRESS was required in 1 eye. One eye experienced hypotony and hyphema, which resolved within a week. XEN implant may be an initial treatment for persistent post SO removal glaucoma with minimal complications. Needling procedures can help maintain or restore surgical success.

Central Retinal Thickness Variability as a Predictive Factor for Visual Acuity After Dexamethasone Implant in Retinal Vein Occlusion.

Investigate central retinal thickness (CRT) variability and changes in best-corrected visual acuity (BCVA) after 12 months in patients with retinal vein occlusion (RVO) treated with dexamethasone intravitreal implants. Post hoc analyses of two randomized trials in patients with macular edema associated with branch or central RVO treated with a 0.7-mg dexamethasone implant. Central retinal thickness standard deviation (CRT-SD) and central retinal thickness amplitude (CRT-A) were measures of variability. Analyses included multinomial and simple linear regression. In 400 patients, CRT-SD and CRT-A were significantly associated with central RVO, second dexamethasone implant, and baseline CRT. Baseline BCVA was associated with CRT-A. CRT-SD and CRT-A were significantly correlated with a 12-month change in BCVA (effect sizes of -0.032 and -0.013 letters/µm; P < 0.001). Patients in the highest CRT-SD quartile gained significantly fewer letters (+1.88 letters; 95% CI: -0.46 to 4.23). Greater CRT variability was associated with smaller BCVA improvements in patients with RVO treated with dexamethasone implants. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.].