Real-life results in treating neovascular age-related macular degeneration with anti-VEGF therapy. Analysis of 122 patients from a single centre

Author(s):  
L. Giralt-Peret ◽  
A. Rodríguez-Urzay ◽  
S. Pérez-Fernández ◽  
N. Martínez-Alday ◽  
A. Fonollosa-Calduch
2021 ◽  
pp. 112067212110378
Author(s):  
Francesco Ciucci ◽  
Giuseppina Ioele ◽  
Antonio Bardocci ◽  
Giorgio Lofoco ◽  
Barbara Antonelli ◽  
...  

Purpose: This is a retrospective, single-center, non randomized interventional real life study, investigating the correlation between variability of central retinal thickness (CRT) and functional outcomes during 2 years of anti-VEGF therapy in patients treated for neovascular age related macular degeneration (nAMD). Background: CRT fluctuations can depend on various factors such as the correct timing of injections, the therapeutic algorithm, and the number of injections (NI) performed; it is important to understand if CRT fluctuations are responsible for worse visual outcomes and consequently to identify the correct ways to avoid or reduce them. Methods: Forty-one patients were treated for nAMD with aflibercept: 0.5 mg intravitreal aflibercept was administered every 4 weeks during the first 3 months, then bimonthly over the first year, and after the first year adopting a PRN regimen. Standard deviation of CRT (CRT/SD), BCVA, and NI were recorded. Correlation studies were performed by Pearson’s test, Ancova, and Principal Component Analysis. Results: A negative correlation was found between CRT/SD and final BCVA. In patients who lost more than 15 letters, CRT/SD mean was significantly higher in comparison with patients who lost less than 15 letters. Patients with final BCVA >65 letters showed lower CRT/SD values compared to patients with final BCVA ⩽65 letters. Multivariate analysis confirmed that in patients with higher baseline BCVA, improvement of BCVA was correlated to NI, and lower values of CRT fluctuations were observed. Conclusions: CRT fluctuations, even after an appropriate NI given per year, significantly influence BCVA; a proactive treatment algorithm appears crucial when treating patients with nAMD.


2021 ◽  
Author(s):  
Alba Parrado-Carrillo ◽  
Marc Figueras-Roca ◽  
Ricardo P. Casaroli-Marano ◽  
Vuong Nguyen ◽  
Daniel Barthelmes ◽  
...  

Abstract Purpose: To implement an intravitreal therapy audit tool for neovascular age-related macular degeneration (nAMD) outcome reporting in a tertiary referral center. Methods: Implementation of an online audit tool (Fight Retinal Blindness platform) for nAMD eyes receiving anti-vascular endothelial growth factor (anti-VEGF) intravitreal therapy over a 24-month follow-up period. Data entry was compliant with the ICHOM dataset for nAMD. These data included visual acuity (VA), eye conditions, injection drug and number of injections. Subgroup analysis was performed for treatment-naive (TN) and previously treated (PT) eyes. Results: 234 eyes (191 patients) were included in the study. No significant differences were observed in the subgroup analysis in mean baseline VA (logMAR letters: 58.8 TN vs 62.7 PT, p= 0.081) or final VA at 12 months (TN 61.4 vs PT 62.4; p= 0.703). However, 12 months median VA change favoured TN cases (+4 TN vs +0 PT, p= 0.010) and median number of injections showed no differences (7 TN vs 7 PT, p= 0.644). No statistically significant differences were found at two years on number of injections even though mean final VA showed significant differences (66 TN vs 59.5 PT, p = 0.032) and VA change favoured the TN group (+2.4 TN vs - 4.6 PT, p= 0.003).Conclusion: We have successfully implemented an online tool to evaluate nAMD anti-VEGF treatment delivered in our center. This feasibility study demonstrates that the online audit tool allows evaluating real world intravitreal therapy outcomes and benchmark these results with clinical practice guidelines and other real-life series.


2021 ◽  
Vol 238 (04) ◽  
pp. 396-402
Author(s):  
Andrea R. Wenkstern ◽  
Christophe Valmaggia

Abstract Background To report visual outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy for exudative age-related macular degeneration (AMD) in a real-life setting. Patients and Methods Retrospective case series of consecutive patients treated with either ranibizumab and/or aflibercept for monolateral or bilateral exudative AMD. A physician established the indication for treatment and administered the injections. An independent physician confirmed the indication for primary treatment. A Pro Re Nata and a Treat and Extend regimen were used. Assessment of subretinal and/or intraretinal fluid, retinal hemorrhage and increase in pigment epithelial detachment served as criteria for further treatment decisions. Visual acuity (VA) was measured in ETDRS letters at each examination and then analyzed using a specialized software. Evolution of mean VA was considered for all study eyes and subgroups of eyes with an initial VA ≥ 70 ETDRS letters (subgroup 1) and ≤ 69 ETDRS letters (subgroup 2). Results A total of 102 eyes of 76 patients (30 men, mean age 75.9 years; 46 women, mean age 81.5 years) were included. Subgroup 1 consisted of 47 eyes, and subgroup 2 of 55 eyes. Mean follow-up was 55 months (range 6 to 150 months). For the entire collective as for subgroups 1 and 2, the mean VA was 64, 77, or 51 ETDRS letters at baseline. Mean VA improved at month 12 (68, 80, or 58 ETDRES letters) and then slowly decreased over time until month 150 (62, 72, or 54 ETDRS letters). Maximum improvement of + 5, + 3, or, + 9 ETDRS letters occurred after 9, 8, or 10 months of follow-up. Atrophy and fibrosis were mainly responsible for VA decrease. Ten serious adverse events were reported to Swissmedic: two cases of cardiovascular events and eight cases of intraocular inflammation. Conclusions Anti-VEGF therapy carried out in a real-life setting shows good VA outcomes with a favorable safety profile.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Paolo Corazza ◽  
Francesco Maria D’Alterio ◽  
Jamil Kabbani ◽  
Mostafa Mohamed Ragheb Alam ◽  
Stefano Mercuri ◽  
...  

Abstract Purpose To describe real-life data from wet age-related macular degeneration (AMD) patients treated with anti-vascular endothelial growth factors (VEGFs) and to compare our results with previous studies and clinical trials. Methods This retrospective monocentric cohort study analyzed 865 eyes of 780 wet-AMD patients treated with an anti-VEGF treat-and-extend regimen over a long-term follow-up period. Aflibercept and Ranibizumab were considered first-line agents whereas Bevacizumab was reserved for use on a compassionate basis in patients not meeting treatment criteria. All patients underwent a best corrected visual acuity (BCVA) assessment at each follow-up visit. Results One-year follow-up figures were available for 82.5% of patients, whilst follow-up data was recorded for 55.6%, 37.6%, 25.1%, and 15.0% of the cohort at years 2, 3, 4, and 5 respectively. Patients treated with Bevacizumab received fewer yearly injections than those treated with Ranibizumab. However, no significant difference in the number of injections per year was detected in other comparisons between groups. Whilst our data showed no significant difference in mean BCVA between the three groups, there was a gradual deterioration of visual function over time for the patient cohort as a whole. Conclusion No significant differences between the 3 anti-VEGF molecules were recorded in wet-AMD patients in real-life conditions. Despite the long-term therapy, we found a slight reduction in visual function especially after the third year of treatment.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yan Lu ◽  
Wenzhi Huang ◽  
Yuehong Zhang ◽  
Xiongfei Huang ◽  
Xu Zhang ◽  
...  

Purpose: To evaluate the treatment solutions and effectiveness of intravitreal ranibizumab (RBZ) or conbercept in patients with wet age-related macular degeneration (wAMD) in a real-life setting in China.Methods: The medical records of 368 patients with wAMD who started RBZ or conbercept treatment between 1 May 2014 and 30 April 2018 were evaluated. All patients were defined on fundus angiography at baseline to determine the subtype of AMD (PCV or CNV). We report visual acuity (VA) and central retinal thickness (CRT) measurements at baseline and 12 months.Results: The average number of anti-VEGF injections was 2.1 ± 1.2. The BCVA improvement of these two groups was similar with a difference of 1.00 letter (95% CI: −1.4~3.4, p = 0.8505). At the end of the study, a BCVA increase of at least 5 letters was determined to be a satisfactory efficacy endpoint. Several factors were related to the possible improvement in the satisfactory efficacy endpoint, including female sex (OR 2.07, 95% CI 1.22~3.51), number of injections (OR 1.40, 95% CI 1.12~1.75) and VA change at the first month (OR 13.75, 95% CI 7.41~25.51). Additionally, some factors were related to the possible reduction in the satisfactory efficacy endpoint, including diabetes (OR 0.27, 95% CI 0.10~0.73) and disease history (OR 0.75, 95% CI 0.57~0.98).Conclusion: Our study demonstrates that anti-VEGF drugs can effectively improve BCVA and reduce CRT in AMD patients. Sex, number of injections, VA change at the first month, diabetes and disease history are the most important factors affecting visual acuity.


2021 ◽  
Vol 15 (1) ◽  
pp. 130-136
Author(s):  
Settimio Rossi ◽  
Carlo Gesualdo ◽  
Antonio Tartaglione ◽  
Giovan Battista Scazzi ◽  
Anna Cristina D’Alessio ◽  
...  

Aim: To evaluate the real utilization of ranibizumab and aflibercept in the daily management of patients with neovascular age-related macular degeneration (nAMD) treated at the Eye Clinic of Campania University L.Vanvitelli. Background: Therapy with anti-vascular endothelial growth factor represents the gold standard in wet age-related macular degeneration. There are nonreal life italian studies of this therapy in the literature. Objective: To analyze in our sample the post-therapy variations of best-corrected visual acuity (BCVA) and central retinal thickness (CRT) observed at the end of a 12-month follow-up period. Methods: This real-life study analyzes 109 patients that underwent monthly checks for the first 4 months and then every 2 months until the end of the 12-month follow-up. The sample was first analyzed in its entirety, subsequently subdivided into 3 groups based on baseline BCVA, age, and the number of intravitreal injections performed, in order to identify possible predictive elements of the anti-VEGF response. Results: On average, patients underwent 4.16 ± 1.58 intravitreal anti-VEGF injections in 1 year. At the end of the 12-month follow-up, the patients’ average BCVA increased from 33.01 letters to 33.75 letters (+0.74 ± 9,4 letters), while the average CRT decreased from 346.86 µm to 265.39 µm (-81.47 ± 121 µm). Conclusion: The study shows the efficacy of anti-VEGF therapy in the stabilization of BCVA in nAMD, confirming the differences in visual outcomes compared to clinical trials, mainly for economic-organizational reasons.


2021 ◽  
Author(s):  
Styliani Blazaki ◽  
Emmanouil Blavakis ◽  
Georgios Smoustopoulos ◽  
Georgios Bontzos ◽  
Anastasios Stavrakakis ◽  
...  

Purpose To evaluate the progression of macular atrophy (MA) based on near-infrared reflectance (NIR) and optical coherence tomography (OCT) images, in patients with age-related macular degeneration (AMD), receiving anti-vascular endothelial growth factor (anti-VEGF) treatment for at least a 6-year period. Materials and Methods This retrospective study included 53 naïve patients (53 eyes) with neovascular AMD from two centers, who were treated with anti-VEGF intravitreal injections and had no MA at baseline. MA was evaluated in an annual basis using NIR images, while all available OCT images were used to confirm that the atrophic area fulfilled the criteria proposed by the Classification of Atrophy Meetings (CAM) group for complete retinal pigment epithelium RPE and outer retinal atrophy (cRORA). Incidence and progression of MA were evaluated. Associations with best-corrected visual acuity (BCVA) and total number of injections were also studied. Results Treatment duration of our patients was 7.34 ± 1.54 years. The mean number of anti-VEGF injections was 24.4 ± 13.6. BCVA at baseline was 0.38 ± 0.27 logMAR while at final visit it was 0.60 ± 0.35 logMAR (p=0.731). The cumulative incidence of new MA at years 1, 2, 3, 4, 5, and 6 was 1.89%, 18.87% 32.08%, 39.62%, 49.06% and 50.94% respectively. In patients who developed MA, mean MA area increased from zero at baseline to 5.66 ± 7.18 mm2 at final visit. The estimated annual enlargement of MA was 0.45 mm/year based on square root transformation (1.12 mm2/year, untransformed data). MA progression does not appear to be significantly associated with age (R=0.055; p=0.784), gender (R=0.113; p=0.576), BCVA (R=0.168; p=0.404) and total number of injections (R=0.133; p=0.255). Conclusion In this real-life setting, half of neovascular AMD patients under anti-VEGF treatment, without MA at therapy initiation, developed MA over a period of at least 6 years. In this work, the number of injections did not seem to have a significant association with MA progression.


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