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

PURPOSE: To report short-term outcomes of treatment switch to faricimab in real-world patients with aflibercept-resistant neovascular age-related macular degeneration (AMD). METHODS: 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. RESULTS: 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: - 31 µm, IQR: 55, p < 0.0001 and median difference: - 21 µm, IQR: 36, p < 0.0001, respectively) and a statistically significant increase in CRT (median difference: + 19 µm, IQR: 20, p = 0.0143) and no change in PED height (median difference: + 22 µm, 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. CONCLUSIONS: 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. STUDY REGISTRATION: ClinicalTrials.gov registration number: NCT06124677. Date of registration: 09/11/2023, retrospectively registered.

Diabetic macular oedema treated with intravitreal anti-vascular endothelial growth factor - 2-4 years follow-up of visual acuity and retinal thickness in 566 patients following Danish national guidelines.

PURPOSE: To investigate long-term functional and anatomical outcomes, discontinuation patterns, drug switching and rates of nonimprovement in patients treated with ranibizumab pro re nata (PRN) regimen for diabetic macular oedema (DME) according to the Danish national guidelines. METHODS: Retrospective cohort study of 566 eyes in 566 patients with centre-involved DME who started intravitreal treatment with ranibizumab between January 2011 and December 2013 in the Greater Copenhagen region. Data were retrieved from a database and patient records between January 2011 and March 2016 and analysed using mixed-model statistics. RESULTS: At the conclusion of follow-up, 24.6% were in active ranibizumab follow-up, 25.4% had switched to other intravitreal pharmacotherapy, 31.6% had been discontinued because of disease stability, 13.8% had been lost to follow-up, 1.4% had been discontinued because of low visual acuity (VA), and 3.2% had died. At baseline, mean best-corrected visual acuity (BCVA) and mean central subfield thickness (CST) were 64.9 (±15.0) letters and 400.2 (±120.3) µm. Mean change in BCVA and mean change in CST from baseline to 3, 12, 24, 36 and 48 months of follow-up were +3.9, +3.5, +2.7, +1.8, +2.3 letters and -97.4, -102.6, -106.9, -105.9, -131.6 µm, respectively. Mean number of injections was 6.1 in year 1 and 1.8 in year 4. In 93 patients, drug switching to aflibercept showed no difference between the two drugs on BCVA or CST. In 79 patients, CST decreased <10% compared to baseline during the first year. CONCLUSION: In a single-centre clinical setting, 566 patients treated for DME with ranibizumab according to the Danish national guidelines were followed for up to 4 years. Best-corrected visual acuity (BCVA) outcomes are in the low end of clinical studies, but studied on a wider population and achieved with fewer injections.

Diabetic Macular Edema Treated with Anti-Vascular Endothelial Growth Factor: Considerations Related to Nonimprovers.

PURPOSE: To investigate central subfield thickness (CST) nonimprovers' anatomic response in macular areas outside the central subfield and the time course of this response. Furthermore, to investigate the relationship between peripheral improvement and visual acuity. DESIGN: Retrospective study. PARTICIPANTS: A total of 566 eyes in 566 patients with center-involved diabetic macular edema who initiated intravitreal treatment with ranibizumab between January 1, 2011 and December 31, 2013 in the Greater Copenhagen Region. Follow-up was completed at 2 years. METHODS: Patients were initially grouped as CST improvers and CST nonimprovers. The CST improvers had a ≥10% reduction in CST on ≥1 visit as opposed to CST nonimprovers with <10% reduction in CST on all visits. The CST nonimprovers were divided into peripheral improvers with ≥10% reduction in retinal thickness in ≥1 subfield outside the central subfield on ≥1 visit and overall nonimprovers with <10% reduction in retinal thickness in all subfields on all visits. Thus, 3 response groups were defined on the basis of retinal thickness change during the first year of treatment: CST improvers, peripheral improvers, and overall nonimprovers. MAIN OUTCOME MEASURES: The OCT total volume and best-corrected visual acuity (BCVA). RESULTS: A total of 79 of 566 patients (14%) were CST nonimprovers, consisting of 45 (57%) peripheral improvers and 34 (43%) overall nonimprovers. For CST improvers and peripheral improvers, total retinal volume decreased from baseline to 3 months: -3.93% per month (95% confidence interval [CI], -4.15 to -3.71) and -2.00% per month (95% CI, -2.74 to -1.26), respectively. Overall nonimprovers' total retinal volume remained unchanged from baseline to 3 months: 0.13% per month (95% CI, -1.02 to 0.76). From 3 to 24 months, the decrease in total retinal volume was not significantly different among the 3 groups. Improvement in BCVA was not significantly different among the 3 groups from baseline to 3 months (P = 0.28). After 3 months, BCVA remained stable. CONCLUSIONS: Some 57% of CST nonimprovers experience a decrease in retinal volume outside the central subfield within the first 3 months of treatment and then remain stable in central and peripheral subfields. However, peripheral improvement did not influence BCVA, and development of BCVA was similar for the response groups. Our study shows that re-treatment criteria should be based on BCVA stability for CST nonimprovers rather than a main reliance on OCT parameters.

Quantification of fluid resorption from diabetic macular oedema with foveal serous detachment after dexamethasone intravitreal implant (Ozurdex® ) in a pregnant diabetic.

PURPOSE: To quantify the fluid resorption from the centre of the fovea in a pregnant woman with diabetic macular oedema by daily optical coherence tomography (OCT) measurements after the administration of intravitreal dexamethasone implant (Ozurdex® ). METHODS: A 36-year-old pregnant woman with type 1 diabetes for 33 years presented with diabetic macular oedema with foveal serous detachment and symptomatic vision loss at 16 gestational weeks. Best-corrected visual acuity (BCVA) in Snellen notation and central retinal volume assessed by optical coherence tomography (OCT, Topcon Corporation) were measured almost on a daily basis the first five weeks after implantation and then 2-3 times per month until childbirth. RESULTS: The pretreatment BCVA was 0.6/1.0, and pretreatment central retinal volume was 0.32 mm3 . Near elimination of the oedema was achieved 3 days after treatment. One week after treatment, BCVA improved to preconception level, and full regression of the oedema was achieved. The rate of fluid resorption from the centre of the fovea was highest 3 days after treatment 0.00139 µL/hr and decreasing to 0.00065 µL/hr 1 week after treatment. CONCLUSION: Intravitreal dexamethasone implant Ozurdex reduces promptly central retinal volume in diabetic macular oedema involving the centre of the fovea in pregnancy with highest rate of fluid resorption 3 days after treatment initiation.

Diabetic macular oedema quantified with spectral-domain optical coherence tomography--evaluation of boundary line artefacts and the effect on retinal thickness.

PURPOSE: To characterize frequency, morphological cause and time-dependent change of boundary line artefacts in optical coherence tomography (OCT) examinations of centre-involved diabetic macular oedema (ciDME) patients who underwent ranibizumab treatment with 1-year follow-up and to evaluate the impact of artefacts on retinal thickness. METHODS: One hundred and fourteen patients were examined with radial scan protocol by Topcon 3D OCT at baseline, 3 and 12 months. All B scans from all visits were examined for boundary line artefacts (artefacts) and were stratified by morphological element causing artefacts including hard exudates (HE), epiretinal membranes (ERM), optical opacities and serous detachments. Boundary line artefacts were manually corrected and the corrected central subfield thickness (CST) and macular volume were compared with automated values. Data were compared with a repeatability coefficient of 25 µm. RESULTS: Boundary line artefacts were found in 51.8% of the total 342 OCT examinations and in 25.5% of the total 2052 B scans. Morphological elements that caused artefacts in the total 2052 B scans were HE (10.6%), ERM (10.3%), optical opacities (4.4%), serous detachments (1.7%) and others (1.2%). The number of artefacts due to HE decreased significantly (p = 0.0005), and the number of artefacts due to ERM were unchanged (p = 0.087) during 12 months. In OCT examinations with artefacts caused by HE, manually corrected CST was statistically significant higher than automated value at baseline and 3 months. For ERM, manually corrected CST was statistically significant lower than automated value at baseline and 12 months. CONCLUSION: Boundary line artefacts in OCT examinations of ciDME patients using Topcon 3D OCT occur in 51.8%. In situation of boundary line artefacts in centre 1-mm area every fourth OCT examination has a change in CST beyond 25 µm.