Cardiovascular risk in patients receiving ranibizumab for exudative age-related macular degeneration: a nationwide self-controlled case-series study

2020 ◽  
pp. bjophthalmol-2020-316373
Author(s):  
Ha-Lim Jeon ◽  
Seong Jun Byun ◽  
Nicole L Pratt ◽  
Janet Sultana ◽  
Sang Jun Park ◽  
...  

AimsTo identify the association between ranibizumab and risk of stroke and acute myocardial infarction (AMI) in patients with exudative age-related macular degeneration (AMD).MethodsWe identified patients aged ≥45 years who received ranibizumab for exudative AMD from the Korean National Health Insurance database. Of these, we selected patients suffering stroke or AMI for the self-controlled case series. We estimated incidence rate ratios (IRR) for stroke or AMI by comparing incidence rates of ranibizumab-exposed periods to that of baseline using conditional Poisson regression. The risks of haemorrhagic and ischaemic strokes were also calculated separately.ResultsAmong 33 134 patients receiving ranibizumab, 2397 patients had stroke or AMI. The risk of stroke (IRR=0.83, 95% CI 0.75 to 0.91) was not increased during the overall exposed period; however, there was a marginally elevated risk in ≥57 days exposed period (IRR=1.14, 95% CI 1.001 to 1.31). When analysing by the types of stroke, no increased risks of haemorrhagic (IRR=1.01, 95% CI 0.80 to 1.26) and ischaemic stroke (IRR=0.78, 95% CI 0.71 to 0.86) were observed during the exposed period, although the risks of ischaemic and haemorrhagic stroke were slightly elevated during ≥57 days exposed period. We could not find an association between ranibizumab and AMI.ConclusionsRanibizumab intravitreal injections did not increase the overall risk of stroke or AMI. Although the cardiovascular risk in patient receiving ranibizumab seems to be low, continuous monthly use of ranibizumab for high-risk patients should be judged carefully.

2021 ◽  
pp. 112067212110017
Author(s):  
Marco H Ji ◽  
Natalia F Callaway ◽  
Cassie A Ludwig ◽  
Daniel Vail ◽  
Ahmad Al-Moujahed ◽  
...  

Purpose: Whether intravitreal anti-vascular endothelial growth factors (VEGFs) cause retinal atrophy is still a subject of debate. We reported 13 eyes that received several injections of anti-VEGF for wet age-related macular degeneration (AMD) with good visual acuity despite geographic atrophy on imaging. Methods: This is a case series study conducted at Byers Eye Institute at Stanford University. Patients of three retina specialists with wet AMD who received six or more intravitreal injection of anti-VEGFs with visual acuity of 20/60 or better and incomplete RPE and outer retina atrophy (iRORA) or complete RPE and outer retinal atrophy (cRORA) were enrolled in this case series. Different imaging modalities were reviewed by three retina specialists comparing the baseline with the most recent exam. Results: About 13 eyes of 10 patients met the selection criteria. Eleven eyes were classified as iRORA and 2 as cRORA. Despite the development of macular atrophy on imaging after an average of 38.1 injections, eyes maintained stable visual acuity. Conclusion: The discrepancy between structural and functional findings in this cohort suggests that patients treated by anti-VEGF drugs exhibit divergent clinical outcomes for currently unknown reasons. The authors propose anti-VEGF may affect melanosomes within RPE without disrupting RPE and photoreceptors function completely. This requires further investigation.


Author(s):  
Mariano Cozzi ◽  
Davide Monteduro ◽  
Salvatore Parrulli ◽  
Federica Ristoldo ◽  
Federico Corvi ◽  
...  

Abstract Purpose The purpose of this study was to investigate the structural variations of the hyporeflective pocket of fluid (prechoroidal cleft) located between Bruch’s membrane and the hyperreflective material within the pigment epithelial detachment (PED) in patients with neovascular age-related macular degeneration (nAMD). Methods In this retrospective, observational case series study, patients diagnosed with nAMD and prechoroidal cleft associated with other activity signs of the macular neovascularization (MNV) were included. Structural optical coherence tomography (OCT) scans were evaluated to obtain anatomical measurements of prechoroidal cleft and PED at three different visits (T0, inactive MNV; T1, active MNV; T2, treated inactive MNV). The variations in size of the cleft and the PED were correlated with nAMD activity. Results Twenty-nine eyes from 27 patients were included. The subfoveal measurements showed a significant increase of prechoroidal cleft height and width from T0 to T1 (P < 0.05) and a subsequent decrease of the cleft height after treatment with anti-VEGF agents (P = 0.004). A similar significant trend was observed for the greatest prechoroidal cleft height and width, obtained assessing the whole OCT raster. In the multivariate analysis, the cleft height was significantly affected by both time (P = 0.001) and PED height (P < 0.0001). By contrast, the effect of fibrovascular tissue size within the PED was not significant. Visual acuity did not correlate with prechoroidal cleft size. Conclusion Prechoroidal cleft increased in association with MNV reactivation and decreased after treatment. Our results suggest that prechoroidal cleft could represent an accumulation of fluid actively exudating from the MNV and should be considered a sign of nAMD activity.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hun Gu Choo ◽  
Jin Hae Lee ◽  
Hyun Sub Oh ◽  
Soon Hyun Kim ◽  
Yong Sung You ◽  
...  

Abstract Background Polypoidal choroidal vasculopathy (PCV) is a type of age-related macular degeneration that can cause permanent vision loss. The purpose of this paper was to report the one-year outcomes of fixed-dosing aflibercept therapy for the treatment of PCV. Methods This was a prospective, single-arm, interventional case series study of 25 PCV patients; 12 pre-treated and 13 treatment-naïve patients. The patients were treated and monitored for 12 months. Each patient was administered with an aflibercept (2.0 mg) injection every month for the first 3 months (the loading phase), and thereafter, once every 2 months. At every follow-up visit, best-corrected visual acuity (BCVA) test, fundus examination, and optical coherence tomography for measuring the central subfield macular thickness (CSMT) were performed. Fluorescein and indocyanine green angiography were conducted at baseline and at 4 and 12 months. Results After 12 months of aflibercept therapy, the mean BCVA of the patients significantly improved from 65.48 letters at baseline to 69.91 letters (p=0.001), and the CSMT significantly decreased from 406.92 um at baseline to 276.12 um (p< 0.001). Additionally, ten patients (40%) showed complete polyp regression. The treatment-naïve patients showed a statistically significant improvement in BCVA from 66.58 letters at baseline to 76.36 letters at 12 months, and a significant decrease in CSMT, from 462 to 243 um. In the pre-treated group, there was no change in BCVA (64.46 letters), and the decrease in CSMT from 356.08 to 303.69 um was not statistically significant. Conclusions The fixed-dosing aflibercept regimen is effective for treating patients with PCV and is more effective in treatment-naïve patients than in pre-treated patients. Trial registration Clinical Research Information Service (CRiS), Republic of Korea. Identifer: KCT0005798, Registered: Jan 20, 2021. Retrospectively registered, URL: https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18546


2017 ◽  
Vol 1 (1) ◽  
pp. 65-74 ◽  
Author(s):  
Bozho Todorich ◽  
Aristomenis Thanos ◽  
Yoshihiro Yonekawa ◽  
Gerta Mane ◽  
Madeleine Hasbrook ◽  
...  

Purpose: To evaluate the efficacy of a dexamethasone intravitreal implant in combination with intravitreal anti-vascular endothelial growth factor (VEGF) agents for treatment-resistant neovascular age-related macular degeneration (nvAMD). Methods: This study was designed as a single-center, retrospective interventional case series. Consecutive patients with treatment-resistant nvAMD underwent simultaneous combined injection of anti-VEGF agent and dexamethasone intravitreal implant. Eighteen patients with mean age of 81.5 years were included. Patients received an average of 26.3 anti-VEGF injections before dual therapy, with a mean follow-up of 8.2 months after dual therapy. Results: Dual therapy produced a significant mean decrease in central foveal thickness (126.3 μm), compared to a mean increase in 29.9 μm when treated with anti-VEGF monotherapy ( P = .0017). Patients also had a mean decrease in macular cube volume of −0.85 mm3 with dual therapy compared to anti-VEGF monotherapy ( P = .0014). There was a moderate correlation between the number of prior anti-VEGF injections and the magnitude of anatomic response, suggesting that shorter disease duration may positively influence response to combined treatment. Although there was a slight trend toward improved mean visual acuity after dual therapy, these differences did not reach statistical significance. Nevertheless, with combination treatment, 33% of patients gained 1 or more lines of vision. Dual therapy resulted in a significantly lower number of required anti-VEGF injections (4.25 vs 5.33) and an increase in the anti-VEGF injection-free interval to 1.41 months from 1.12 months during the 6 months following dual therapy compared to the same interval before dual therapy. Dual therapy was well tolerated; 2 eyes developed mild intraocular pressure elevation effectively managed with topical therapy and 1 patient developed worsening cataract. Conclusions: Combined treatment of anti-VEGF with dexamethasone intravitreal implant is a viable alternative for treatment-resistant nvAMD and may reduce treatment burden. Earlier treatment with dual therapy may be beneficial to maximize anatomic and visual outcomes in these patients.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Yanel Gayadine-Harricham ◽  
Virginie Rufin ◽  
Sandrine Law-Koune ◽  
Thi Ha Chau Tran

Introduction. The objective of the study is to report 4-year treatment outcome with intravitreal Aflibercept injections for neovascular age-related macular degeneration (nAMD) as first life therapy in real-life. Patients and Methods. This is a prospective, monocenter, observational case series analysis. Data from treatment-naïve patients with nAMD with at least 4 years of follow-up were included in the analysis. Data including age, gender, and visual acuity measured on Early Treatment of Diabetic Retinopathy Study charts (ETDRS) and injection numbers were recorded. Spectral domain optical coherence tomography (SD-OCT) data at baseline, month 3, month 6, month 12, year 2, 3, and 4 were also recorded. Patients were treated with a modified treat and extend (T&E) regimen. Results. Of the 48 eyes with nAMD treated, only 31 eyes were available at the 4-year follow-up. The mean age was 81 ± 8 years. The VA gain was 7.3 ± 12.7 letters at 1 year 6.5 ± 12.5 letters at 2 years, VA gain 5.2 ± 17 letters at 3 years, and 6.2 ± 18.6 letters at 4 years. The reduction of central retinal thickness was 118 ± 187 μm at 4 years. Complete resolution of fluid was obtained in 18/31 eyes. The total number of injections was 5.7 ± 2.0 during the first year, 2.9 ± 2.9 during the second year, 3.5 ± 3.3 during the third year, and 4.0 ± 3.4 during the fourth year. The total number of injections was 16 ± 10.6, ranging from 3 to 52 injections. Ten eyes developed macular atrophy over the 4-year period. Conclusion. The results suggest that good long-term morphological and functional outcome can be achieved using Aflibercept in clinical setting.


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