Pigment Epithelial Tear Research Articles

Double retinal pigment epithelial tears following intravitreal ranibizumab injection for neovascular age-related macular degeneration

Double retinal pigment epithelial tears following intravitreal ranibizumab injection for neovascular age-related macular degeneration

Brolucizumab in patients with neovascular age-related macular degeneration: Real-life outcomes from a tertiary care eye hospital.

To report real-world clinical evidence of brolucizumab in treating neovascular age-related macular degeneration (nAMD). This study included 37 eyes with nAMD treated with intravitreal injections of brolucizumab. The main outcomes were best corrected visual acuity (BCVA) changes, central retinal thickness (CRT), and serious ocular adverse events. Intraretinal fluid (IRF) and subretinal fluid (SRF), subretinal hyperreflective material (SHRM), pigment epithelial detachments (PEDs), hyperreflective foci, macular atrophy, and retinal pigment epithelial tears were evaluated. The mean BCVA of all patients showed a post-treatment value of 0.47 ± 0.33 log of minimum angle of resolution (LogMAR), compared to a baseline measure of 0.50 ± 0.28 LogMAR (P = 0.372). For treatment-naïve patients, a non-statistically significant improvement in BCVA was observed (P = 0.116). Both treatment-naive patients and the entire patient cohort exhibited a statistically significant improvement in the mean CRT after injections. Majority of patients exhibited improvements in optical coherence tomography findings, specifically in the resolution of IRF, SRF, SHRM, and PEDs. Four eyes experienced ocular adverse events in the form of intraocular inflammation. Brolucizumab did not yield a substantial improvement in BCVA, but it exhibited efficacy in reducing CRT in the entire study population and treatment-naive patients with nAMD. Our study identified intraocular inflammation as a significant adverse event with brolucizumab. Thus, precise patient selection, education, and vigilant inflammation monitoring are crucial for patients undergoing this treatment.

Анализ ОКТ-предикторов анатомических и функциональных результатов aнтиангиогенной терапии отслойки пигментного эпителия при неоваскулярной возрастной макулярной дегенерации

Abstract Analysis of OCT predictors of anatomical and functional results of anti-VEGF therapy of pigment epithelium detachment in neovascular age-related macular degeneration E.V. Kozina, S.N. Sakhnov, V.V. Myasnikova, E.V. Bykova S. Fyodorov Eye Microsurgery Federal State Institution, Krasnodar branch, Krasnodar, Russian Federation Kuban State Medical University Ministry of Health of Russia, Krasnodar, Russian Federation Purpose. Analysis of optical coherence tomography (OCT) biomarkers for anatomical results prediction of anti-angiogenic therapy (antiVEGF) of pigment epithelial detachments (PED) in neovascular macular degeneration (n-AMD). Material and methods. Primary tomograms of 260 patients with PED higher than 200 µm were analyzed. The shape, height, length of the detachment and subpigmentary space reflectivity were assessed. After anti-VEGF injections, reattachment of PED according to OCT was observed in 114cases (44%) – 1st group; in 111 cases (43%) OCT showed PED resistance – 2nd group; in 35 cases (13%), the pigment epithelium tear (RPET) of 3–4 degrees was happened – 3rd group. In each OCT were studied of the following biomarkers: the ellipsoidal zone and RPE integrity, intra – and subretinal fluid, the drusen under RPE around PED, hyperreflective foci in retina. Results. A statistically significant difference was revealed between 1st and 2nd groups in the height and length of pigment epithelium detachment: PED height (506.2±204.3 µm) and length (3206.2±722.1 µm) have a tendency to reattachment during anti-VEGF therapy (р<0.05). High PED with neuroepithelial detachment has a higher risk of RPET (р<0.05). Presence of RPE defects and large hyperreflective foci in the retina can be considered as a predictor of the PED reattachment (р<0.05). Low PED with reflectivity subpigmentary space is a predictor of PED resistance (р<0.05). Conclusion. Patients with high PED, with neuroepithelial detachment, should be given antiVEGF therapy with great caution. Lower PED with hyperreflectity under PED tend to be anatomically resistant to therapy. Biomarkers of the adherence of the PE can be RPE defects and large hyperreflective inclusions in the internal layers. Key words: retinal pigment epithelium detachment, pigment epithelium tear, OCT biomarkers, hyperreflective foci, antiangiogenic therapy

One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan

This multicentre retrospective study evaluated the 1-year outcomes and safety profile of faricimab in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Fifty-five patients (57 eyes) underwent loading therapy comprising three monthly faricimab injections. If dryness was achieved by the third month, subsequent treat-and-extend (TAE) follow-up continued at a minimum 8-week interval thereafter. If wet macula persisted at the third month, a fourth dose was administered, followed by the TAE regimen. After 1 year, improvements in visual acuity (0.44 ± 0.46 [baseline] to 0.34 ± 0.48; p < 0.01) and central foveal thickness (326 ± 149 [baseline] to 195 ± 82 μm; p < 0.0001) were significant. Dry macula, characterised by the absence of intraretinal or subretinal fluid, was achieved in 65% of cases. Treatment intervals varied, ranging from 8 to 16 weeks, with 44% of eyes extending to a 16-week interval, followed by 33% at 8 weeks, 16% at 12 weeks, 5% at 14 weeks, and 2% at 10 weeks. Notably, 50% of the polypoidal choroidal vasculopathy patients exhibited complete regression of polypoidal lesions between 12 and 15 months. Faricimab treatment in nAMD patients induced significant improvements in central vision and retinal morphology. Two cases of retinal pigment epithelial tears and one case of iritis were reported as ocular complications.

Long-term Follow-Up and Regeneration of Retinal Pigment Epithelium (RPE) after Tears of the Epithelium in Exudative Age-Related Macular Degeneration (AMD).

The goals of this study are to evaluate potential long-term visual deterioration associated with retinal pigment epithelial (RPE) tears in patients with neovascular age-related macular degeneration (nAMD) and to find treatment-related and morphological factors that might influence the outcomes. This retrospective study enrolled 21 eyes of 21 patients from the database of Vista Eye Clinic Binningen, Switzerland, diagnosed with RPE tears, as confirmed by spectral domain optical coherence tomography (SD-OCT), with a minimum follow-up period of 12 months. Treatment history before and after RPE rupture with anti-VEGF therapy, visual acuity, and imaging (SD-OCT) were analyzed and statistically evaluated for possible correlations. Mean patient age was 80.5 ± 6.2 years. The mean length of total follow-up was 39.7 ± 13.9 months. The mean pigment epithelial detachment (PED) height increased by 363.8 ± 355.5 µm from the first consultation to 562.8 ± 251.5 µm at the last consultation prior to rupture. Therefore, a higher risk of RPE rupture is implied as a result of an increase in PED height (p = 0.004, n = 14). The mean visual acuity before rupture was 66.2 ± 16.0 letters. Mean visual acuity deteriorated to 60.8 ± 18.6 letters at the first consultation after rupture (p = 0.052, n = 21). A statistically nonsignificant decrease in vision was noted in the follow-up period. After 2 years, the mean BCVA decreased by 10.5 ± 23.7 ETDRS letters (p = 0.23, n = 19). PED characteristics before rupture and amount of anti-VEGF injections after rupture did not affect the visual outcome. None of the 21 patients included in our study showed a visual improvement in the long-term follow-up. RPE atrophy increased significantly from 3.35 ± 2.94 mm2 (baseline) to 6.81 ± 6.25 mm2 over the course of 2 years (p = 0.000 013, n = 20). The overall mean vision decrease after rupture was without statistical significance. There was no significant change in BCVA at the 2-year follow-up, independent of the amount of anti-VEGF injections provided. In this study, there was a significant increase in RPE defect over a follow-up of 2 years, implying progression of contraction of RPE and/or macular atrophy.

OCT biomarkers in wet type age related macular degeneration

OCT technology is evolving very quickly, and new retinal biomarkers are continuously described. Optical coherence tomography (OCT) is the most widely used technology for the diagnosis and follow‐up of AMD patients, which is widely used to study and guide the clinical approach, as well as to predict and evaluate treatment response.OCT biomarkers in wet type age related macular degeneration can be divided into two different categories.Biomarkers based on the retinal distribution of fluids and, structural biomarkers based on the presence or absence of specific features can be observed in the retinal layers, choroid, or vitreomacular interface.The aim of this review is to describe and analyse various structural OCT‐based biomarkers, which have practical value during both initial assessment and treatment follow‐up of wet type AMD patients.Central retinal thickness has been the most common and one of the first OCT identified biomarkers, today, other qualitative and quantitative biomarkers provide novel insight into disease activity and offer superior prognostic value and better guidance for tailored therapeutic management.The key importance of retinal fluid compartmentalization (intraretinal fluid, subretinal fluid, and subretinal pigment epithelium (RPE) fluid).In the second part, the structural alterations of different retinal layers in various stages of the disease (photoreceptors layer integrity, hyperreflective dots, outer retinal tubulations, subretinal hyperreflective material, and retinal pigment epithelial tears) will be analysed in detail.The last part of the review will focus on how alterations of the vitreoretinal interface (vitreomacular adhesion and traction) and of the choroid (sub‐RPE hyperreflective columns, pre‐choroidal clefts, choroidal caverns, choroidal thickness and choroidal volume, and choroidal vascular index) interact with AMD progression.This up‐to‐date review article provides a comprehensive description on how structural OCT‐based biomarkers provide a valuable tool to monitor the progression of the disease and the treatment response in AMD patients.

Морфофункциональные особенности пигментного эпителия сетчатки в норме и при возрастной макулярной дегенерации

Relevance. The retinal pigment epithelium performs a number of highly specialized functions. The relevance of studying morphological changes in the pigment epithelium is associated with an increased number of patients with age-related macular degeneration (AMD), polypoid choroidal vasculopathy, central serous retinopathy and retinitis pigmentosa. The increase in the number of patients with these pathologies is associated both with the general trend of aging of the world's population and with modern opportunities for mass diagnostics. Pathomorphological changes in the pigment layer are an important indicator of the development of AMD. Purpose. To analyze features of retinal pigment epithelium in normal and pathological conditions. Material and methods. The literature review was carried out using PubMed and Sochape Library. Results. Several authors present data about the complication of retinal detachment with development of the retinal pigment epithelium tear. The key criterion for tear treatment is the height of the pigment layer detachment. Violation of the integrity of the pigment layer in the long term is a factor in decrease or complete loss of vision. This is especially characteristic when a tear is formed in the central area of the retina. Also, visual impairment is observed in cases of submacular hemorrhage and fibrous scar formation. Conclusion. An important point, at present, is guidelines development for patients with pigment epithelium tears, it will allow to manage this condition on the background of concomitant disease. Key words: retinal pigment epithelium, age-related macular degeneration, pigment epithelium tear

Comparison of functional and morphologic changes between brolucizumab and faricimab in neovascular age-related macular degeneration.

This study aimed to compare functional and morphologic changes in the loading phase between patients with treatment-naïve macular neovascularization (MNV) due to neovascular age-related macular degeneration (nAMD) treated with either intravitreal brolucizumab (IVBr) or intravitreal faricimab (IVF) injections in a clinical setting. We retrospectively studied 92 consecutive eyes of 90 patients with neovascular nAMD who were scheduled to receive IVBr (42 eyes of 41 patients) or IVF (50 eyes of 49 patients) injections between October 2021 and December 2022. All patients received three consecutive monthly injections of 6.0 mg/0.05 mL brolucizumab or 6.0 mg/0.05 mL faricimab. The best-corrected visual acuity (BCVA), central foveal thickness (CFT), and central choroidal thickness (CCT) at baseline and 1, 2, and 4 months after the initial treatment were measured and compared between the groups. Thirty-seven eyes in IVBr group and forty-seven eyes in IVF group who finished treatments in the loading phase were assessed at the follow-up examination. The BCVA, CFT, and CCT changed significantly after loading phase in both groups (P < 0.05 for both comparisons). The IVBr group had more rapid improvement of the BCVA (P = 0.037) at 1 month than the IVF group, but there was no difference at 4 months (P = 0.367). The CFT and CCT decreases tended to be greater in the IVBr group than in the IVF group throughout the follow-up period. Of the five eyes excluded from the IVBr group, one eye (2.4%) each had intraocular inflammation (IOI) and was a non-responder, and two eyes (4.8%) had retinal pigment epithelial tears after treatment. Of the three eyes excluded from the IVF group, two eyes (4.0%) did not respond to the treatment. Both IVBr and IVF injections were well-tolerated and improved the VA in treatment-naïve patients with MNV due to nAMD after a loading phase, although IVBr caused a trend towardfaster visual improvements in the BCVA. The IVBr group also had greater reductions of the CFT and CCT than the IVF group. However, the potential for adverse events and no response to treatment with each drug are considerations.

Response to brolucizumab treatment for refractory serous pigment epithelial detachment secondary to polypoidal choroidal vasculopathy

PurposeTo report the efficacy and safety of brolucizumab in the treatment of refractory serous pigment epithelial detachment (PED) secondary to polypoidal choroidal vasculopathy (PCV).MethodsTwenty-six eyes of 26 patients were included. Intravitreal brolucizumab 6.0 mg was administered, followed by pro re nata (PRN) retreatment at monthly follow-ups. All patients underwent spectralis domain optical coherence tomography (SD-OCT), fluorescein angiography, and indocyanine green angiography before the first brolucizumab injection. SD-OCT was repeated at follow-up visits. The height and width of the serous PEDs, measured using SD-OCT, were analyzed.ResultsThe number of previous anti-VEGF injections was 12.3 ± 15.0. During brolucizumab treatment, anatomical improvement was achieved and maintained in the height and width of the PEDs (p < 0.05). However, the visual outcome did not improve significantly (p > 0.05). A good response was achieved in 69.2% of eyes at 1 month and at the last visit. Relapse and complete resolution were observed in 27.8 and 23.1% of patients, respectively. The number of brolucizumab injections was 2.00 ± 0.85. Intraocular inflammation, vascular obstruction, and retinal pigment epithelial tears were not observed.ConclusionIntravitreal brolucizumab may be an effective and safe treatment option for refractory serous PEDs in patients with PCV.

Retinal pigment epithelial (RPE) tears after serous pigment epithelial detachment (PED) in wet AMD: A retrospective study of 23 patients

AbstractPurpose: Age‐related macular degeneration (AMD) is one of the main causes for vision impairment. Pigment epithelial detachment (PED) is a common finding, which in its serous form is associated with wet AMD. PED can lead to retinal pigment epithelial (RPE) tears, which are associated with a further loss in vision. One known risk factor for RPE ruptures is the use of anti‐VEGF injections in patients with persisting PED. The aim of our study was to identify morphological parameters in the SD‐OCT that could present risk factors for RPE tears. Furthermore, this study aims at helping to predict functional and morphological outcomes for patients with RPE tears associated with PED in AMD.Methods: All patients in the database of Vista Augenklinik Binningen, Switzerland, diagnosed with RPE tears in SD‐OCT were included. Patients who presented with RPE tears at their first consultation were excluded from the study. Both morphological factors in imaging (SD‐OCT, FAF), as well as the history of anti‐VEGF injections prior and after the RPE tears occurred, were retrospectively analysed.Results: 23 eyes of 23 patients (57% females) were included. At the time of the RPE tear, the mean age was 81.9 ± 13.1 years (range: 70–95 years, median: 83 years). Mean follow‐up time was 28.7 ± 31 months (range: 1–52 months) after the rupture. The mean height of PED was 324.5 μm (range: 24‐837 μm) at the first consultation. In 6 out of 7 patients (86%) with initial PED height &gt; 526 μm, an RPE rupture occurred between the first and second consultation. 4 out of those 6 patients (67%) had received their first anti‐VEGF injection. Only 2 out of the other 16 patients (12%) with PED ≤375 μm had a rupture between the first and second consultation. The mean PED height in the last OCT imaging before rupture was 563 ± 486.55 μm (range: 121‐1039 μm). 8 patients (35%) had received exactly one anti‐VEGF injection before the rupture (mean height before rupture: 580,5 μm), another 8 patients (35%) received more than one injection (range: 2–55, mean height before rupture: 589,1 μm) and 7 patients (30%) did not receive anti‐VEGF injections (mean height before rupture: 513.1 μm).Conclusions: The risk of RPE tears should be considered when treating patients with PED in wet AMD. Further studies with larger sample sizes should be encouraged in addition to the existing scores.

Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS).

Background: The purpose of this study is to identify and characterize ocular adverse events (AEs) that are significantly associated with anti-VEGF drugs for treatment of neovascular age-related macular degeneration and compare the differences between each drug, and provide clinical reference. Methods: Ocular AEs submitted to the US Food and Drug Administration were analyzed to map the safety profile of anti-VEGF drugs. The Pharmacovigilance tools used for the quantitative detection of signals were reporting odds ratio and bayesian confidence propagation neural network. Results: A total of 10,608,503 AE reports were retrieved from FAERS, with 20,836 for ranibizumab, 19,107 for aflibercept, and 2,442 for brolucizumab between the reporting period of Q1, 2004 and Q3, 2021. We found and analyzed the different AEs with the strongest signal in each drug-ranibizumab-macular ischaemia (ROR = 205.27, IC-2SD = 3.70), retinal pigment epithelial tear (ROR = 836.54, IC-2SD = 7.19); aflibercept-intraocular pressure increased (ROR = 31.09, IC-2SD = 4.61), endophthalmitis (ROR = 178.27, IC-2SD = 6.70); brolucizumab-retinal vasculitis (ROR = 2930.41, IC-2SD = 7.47) and/or retinal artery occlusion (ROR = 391.11, IC-2SD = 6.10), dry eye (ROR = 12.48, IC-2SD = 2.88). Conclusion: The presence of AEs should bring clinical attention. The use of anti-VEGF drugs should be based on the patient's underlying or present medical condition to reduce any adverse event associated with the treatment.

Dexamethasone implant prior to anti-VEGF therapy in pigment epithelium detachments with high-risk rupture characteristics secondary to neovascular age-related macular degeneration

ObjectiveEvaluate the incidence of pigment epithelial tear when intravitreal delayed-release dexamethasone implant is administered (off-label use) prior to antiangiogenic treatment in pigment epithelium detachments (PED) secondary to neovascular age-related macular degeneration (nAMD) with high-risk rupture characteristics and investigate if it causes a decrease in the PED size. MethodsPatients with nAMD, PED height >500 microns and Ozurdex implant prior to the antiangiogenic therapy were included. The presence of pigment epithelium rupture in optical coherence tomography scans, best-corrected visual acuity (BCVA) and PED measurements (maximum height and diameter) were registered. ResultsThe study included 14 eyes of 14 patients: mean age 77 ± 7 years, 11 (79%) females. 25 ± 13 days after the Ozurdex, patients started with at least 3 anti-VEGF monthly injections. BCVA improved from 64 ± 14–69 ± 11 letters after anti-VEGF therapy (p > 0.05). Mean baseline PED height was 817 ± 269 µm, being 639 ± 268 µm after Ozurdex and 370 ± 260 µm after anti-VEGF injections (p = 0.035 and p = 0.009). One retinal pigment epithelium tear occurred (7%). No other adverse effects were reported. ConclusionsDexamethasone implant prior to anti-VEGF therapy may represent a promising therapeutic modality for large PED in nAMD, reducing PED dimensions and the risk of pigment epithelium tears prior to anti VEGF therapy.

Implante de dexametasona antes de tratamiento anti-VEGF en desprendimientos del epitelio pigmentario secundarios a degeneración macular asociada a la edad con características de alto riesgo de rotura

ObjectiveEvaluate the incidence of pigment epithelial tear when intravitreal delayed-release dexamethasone implant is administered (off-label use) prior to antiangiogenic treatment in pigment epithelium detachments (PED) secondary to neovascular age-related macular degeneration (nAMD) with high-risk rupture characteristics and investigate if it causes a decrease in the PED size. MethodsPatients with nAMD, PED height >500microns and Ozurdex implant prior to the antiangiogenic therapy were included. The presence of pigment epithelium rupture in optical coherence tomography scans, best-corrected visual acuity (BCVA) and PED measurements (maximum height and diameter) were registered. ResultsThe study included 14 eyes of 14 patients: mean age 77±7 years, 11 (79%) females. 25±13 days after the Ozurdex, patients started with at least 3 anti-VEGF monthly injections. BCVA improved from 64±14 to 69±11 letters after anti-VEGF therapy (P>.05). Mean baseline PED height was 817±269μm, being 639±268μm after Ozurdex and 370±260μm after anti-VEGF injections (P=.035 and P=.009). One retinal pigment epithelium tear occurred (7%). No other adverse effects were reported. ConclusionsDexamethasone implant prior to anti-VEGF therapy may represent a promising therapeutic modality for large PED in nAMD, reducing PED dimensions and the risk of pigment epithelium tears prior to anti VEGF therapy.

Visual Outcome after Vitrectomy with Subretinal tPA Injection to Treat Submacular Hemorrhage Secondary to Age-Related Macular Degeneration or Macroaneurysm.

Purpose To determine the efficacy and safety of 23G transconjunctival sutureless vitrectomy, subretinal injection of tissue plasminogen activator using the EVA Surgical System, and pneumatic displacement with air to treat submacular hemorrhages. Methods Retrospective analysis of 93 eyes surgically treated for submacular hemorrhage caused by neovascular AMD or retinal macroaneurysms. Main Outcome Measures. Postoperative visual acuity and surgical complications. Results After surgery, visual acuity improved after 6 weeks but decreased again at the final postoperative visit at 8 months due to progression of the underlying disease. Complications consisted of 2 cases of retinal pigment epithelial tear, 7 vitreous hemorrhages, 4 hyphema, 6 cases of retinal detachment, and 2 subchoroidal hemorrhages during the follow-up period. Conclusions This study suggests that a surgical approach with 23G vitrectomy, subretinal tPA injection, and pneumatic displacement using air may be an effective procedure for submacular hemorrhage displacement in patients with AMD and retinal macroaneurysms. However, visual outcome is limited by the underlying macular pathology. Larger multicenter randomized controlled studies are warranted to determine the therapeutic effect of this surgical approach.

Retinal pigment epithelial tear following intravitreal brolucizumab in neovascular age-related macular degeneration

Retinal pigment epithelial tear following intravitreal brolucizumab in neovascular age-related macular degeneration

Brolucizumab in Neovascular Age-Related Macular Degeneration - Indian Real-World Experience: The BRAILLE Study.

PurposeTo assess the short-term efficacy and safety profile of intravitreal brolucizumab injection in Indian eyes with neovascular age-related macular degeneration (nAMD) under real-world conditions.Patients and MethodsThis was a multicenter, retrospective chart review of 94 eyes of 94 patients with nAMD (treatment-naïve and switch-therapy) undergoing brolucizumab therapy. Re-treatment as per pro-re-nata protocol was performed based on fixed visual and tomographic criteria. The main outcome measures were changes in the best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central subfield thickness (CST), and pigment epithelial detachment (PED) along with safety analysis.ResultsOf the 94 eyes, 20 eyes (21.3%) were treatment-naïve, whereas the rest 74 eyes (78.7%) underwent switch therapy. One hundred and twenty-six injections were given over a mean follow-up of 7.3 ± 2.2 (range 5–30) weeks. The BCVA improved significantly from 0.82 ± 0.5 LogMAR at baseline to 0.66 ± 0.5 LogMAR at the final visit (p < 0.0001). Significant reduction in CST was simultaneously noted (Baseline: 408.45 ± 65.63 µm; Final: 281.14 ± 37.74 µm; p < 0.0001). On qualitative analysis, resolution of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) was observed in 15.5%, 39.29%, and 23.81% of the eyes, respectively. The mean interval of repeat injection was 10.2 ± 2.1 weeks. Three episodes of ocular adverse drug reaction were reported, including two patients developing subretinal hemorrhage while one having a retinal pigment epithelial (RPE) tear. Notably, no intraocular inflammation (IOI) was seen in any of the eyes, and no systemic side effects were identified.ConclusionIn a real-world scenario, brolucizumab therapy is efficacious and safe in the management of nAMD over the short term. Further long-term studies are warranted to validate these findings. Additionally, lack of ocular inflammation after 126 brolucizumab injections in our Indian data is peculiar and underlines the necessity to explore the role of race and genetics in predisposing to/safeguarding against brolucizumab-related IOIs.

OCT Biomarkers in Neovascular Age-Related Macular Degeneration: A Narrative Review

Age-related macular degeneration (AMD) is the leading cause of legal blindness in elderly people. Neovascular AMD (nAMD) is responsible for the majority of cases of severe visual loss in eyes with AMD. Optical coherence tomography (OCT) is the most widely used technology for the diagnosis and follow-up of nAMD patients, which is widely used to study and guide the clinical approach, as well as to predict and evaluate treatment response. The aim of this review is to describe and analyze various structural OCT-based biomarkers, which have practical value during both initial assessment and treatment follow-up of nAMD patients. While central retinal thickness has been the most common and one of the first OCT identified biomarkers, today, other qualitative and quantitative biomarkers provide novel insight into disease activity and offer superior prognostic value and better guidance for tailored therapeutic management. The key importance of retinal fluid compartmentalization (intraretinal fluid, subretinal fluid, and subretinal pigment epithelium (RPE) fluid) will be discussed firstly. In the second part, the structural alterations of different retinal layers in various stages of the disease (photoreceptors layer integrity, hyperreflective dots, outer retinal tubulations, subretinal hyperreflective material, and retinal pigment epithelial tears) will be analyzed in detail. The last part of the review will focus on how alterations of the vitreoretinal interface (vitreomacular adhesion and traction) and of the choroid (sub-RPE hyperreflective columns, prechoroidal clefts, choroidal caverns, choroidal thickness and choroidal volume, and choroidal vascular index) interact with nAMD progression. OCT technology is evolving very quickly, and new retinal biomarkers are continuously described. This up-to-date review article provides a comprehensive description on how structural OCT-based biomarkers provide a valuable tool to monitor the progression of the disease and the treatment response in nAMD patients. Thus, in this perspective, clinicians will be able to allocate hospital resources in the best possible way and tailor treatment to the individual patient's needs.

Brolucizumab for Choroidal Neovascular Membrane with Pigment Epithelial Tear and Subretinal Fluid.

The aim of this study was to determine the utility of brolucizumab in the management of choroidal neovessels (CNV) with a retinal pigment epithelial (RPE) tear and subretinal fluid. We used a case series of patients with CNV who developed an RPE tear either spontaneously or following an intravitreal injection. All patients received intravitreal brolucizumab as primary or switch therapy. Appropriate data were collected. Follow-up was one year. The paired t-test was used to determine the significance of the results. The primary outcome measure was the change in best corrected visual acuity (BCVA). Secondary outcome measures were the change in subretinal fluid and complications, if any. A total of five patients were included in the analysis. The age range was 67−74 years and baseline BCVA was from 20/80 to 20/100. On average, all patients showed improvement in BCVA (p = 0.012) and also showed a significant anatomical improvement (p = 0.03). None of the patients had any complications, and all patients responded to additional anti-VEGF injections. In conclusion, all patients showed significant visual and anatomical improvement with brolucizumab; no complications were noted. All patients, including those who received switch, demonstrated a favorable anatomical and visual response to intravitreal brolucizumab without safety concerns.

Real-World Safety Outcomes of Intravitreal Ranibizumab Biosimilar (Razumab) Therapy for Chorioretinal Diseases.

IntroductionTo assess the safety profile of the intravitreal ranibizumab biosimilar molecule, Razumab® (Intas Pharmaceuticals, Ahmedabad, India) in chorioretinal disorders under real-world conditions.MethodsThis was a multicenter, retrospective chart review which included patients from 15 centers receiving intravitreal Razumab (IVRz) injections from 2016 to 2020. Patient demographics, ocular examination data, and detailed safety information regarding serious adverse events (SAE) or serious adverse drug reactions (sADR), and non-serious AEs (nsAE) or non-serious ADRs (nsADR) occurring within 1 month of IVRz injections were compiled.ResultsA total of 6404 eyes of 6404 patients received 9406 IVRz injections [mean (± SD) = 1.49 (± 0.63)] during 4.25 years. Adverse events were reported after 1978 injections (21.03%): 64.16% nsAE, 32.96% nsADR, 2.37% sADR, and 0.51% SAE. The most frequent adverse events were subconjunctival hemorrhage (8.2% of total injections), transient blurring of vision (6.5% of total injections), and mild ocular pain (5.27% of total injections). Serious ocular (31 cases with retinal pigment epithelial tears [0.33%], two cases of non-infectious vitritis [0.02%], and one case of endophthalmitis [0.01%]) and systemic (seven patients with non-fatal myocardial infarction [0.12%] and six patients with non-fatal cerebrovascular accident [0.09%]) adverse events were infrequent.ConclusionThe study reports the largest pooled safety data on IVRz use in a real-world scenario. The results did not raise any new ocular or systemic safety concerns for the biosimilar agent, with the incidence and spectrum of adverse reactions similar to those reported with other anti-vascular endothelial growth factor (anti-VEGF) drugs. The real-world evidence suggests that IVRz is a safe anti-VEGF agent in the management of chorioretinal disorders.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-021-00345-2.

Retinal pigment epithelial tear following intravitreal injection of brolucizumab

Retinal pigment epithelial tear following intravitreal injection of brolucizumab