scholarly journals Implementation of An Intravitreal Therapy Online Audit Tool For Neovascular Age-related Macular Degeneration Clinical Outcomes Reporting: Fight Retinal Blindness Spain (FRB-Spain) Project

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 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 ◽  
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.


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.


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.


2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Martin Stattin ◽  
Julia Forster ◽  
Daniel Ahmed ◽  
Anna-Maria Haas ◽  
Alexandra Graf ◽  
...  

Purpose. To evaluate 7-year visual and anatomical outcomes of intravitreal injections (IVI) with antivascular endothelial growth factor (anti-VEGF) for neovascular age-related macular degeneration (nAMD) based on a personalized pro re nata (PRN) regimen. Methods. Anonymized data of 124 consecutive eyes in 121 patients with treatment-naïve nAMD were initially collected in 2010. Of those, 45 received anti-VEGF IVI at least every 6months until 2017 in one single center in Austria and hence were retrospectively analyzed. All eyes had been initiated on a loading dose of 3 monthly IVI with different anti-VEGF agents followed by a PRN regimen in the first year. At year 2, monitoring as well as therapeutic intervention could be prolonged every 2weeks up to intervals of 3months without capping treatment. Primary outcome measure was the change of visual acuity (VA) assessed by Early Treatment Diabetic Retinopathy Study charts at 4 meters (ETDRS) in letters—counting every correctly read letter—and converted to Snellen. Secondary outcome measures were number of injections and change of central retinal thickness (CMT) from baseline. Results. Mean baseline VA was 20/63 + 1 (0.63 ± 0.26 ETDRS) and declined to 20/100 + 2 (0.45 ± 0.33) with an overall loss of 9 letters ETDRS after 7years (p = 0.001). An average of 3.5 ± 1.9 IVI was given per year and eye. Mean CMT at baseline was 322 ± 95 μm, decreased by 52 μm to 270 ± 70 μm within the first year, and remained below baseline at year 7 (271 ± 106 μm; p<0.001). Conclusions. Our data confirm an absolute vision loss in eyes compromised by nAMD after 7 years of continuous VEGF inhibition. The visual decline was significantly related to baseline VA as well as the number of injections. We suggest following patients thoroughly independent of the initial VA and a greater incentive for the physician to treat.


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.


2013 ◽  
Vol 07 (02) ◽  
pp. 109
Author(s):  
Javier Araiz ◽  
Luis Arias ◽  
Alfredo García-Layana ◽  
José María Ruiz-Moreno ◽  
◽  
...  

Ranibizumab is an antibody fragment (Fab) that binds and inhibits all isoforms of vascular endothelial growth factor (VEGF), which is considered the main target in neovascular age-related macular degeneration (nAMD). Based on scientific evidence of the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR)/Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD (MARINA) studies, intravitreal ranibizumab is indicated in all typical types of nAMD. Nevertheless, specific forms such as retinal angiomatous proliferation (RAP), polypoidal choroidal vasculopathy (PCV) and bad or non-responders may need combination therapies to increase the efficacy and reduce the number of injections. Due to the frequent office visits and injections required with a monthly ranibizumab therapy, several dosing strategies have been evaluated to maintain optimal efficacy while reducing the number of injections and visits in the clinical practice.Pro re nata(PRN) and ‘Treat and Extend’ are the most popular individualised therapeutic regimens. Few studies address long-term results of ranibizumab. It remains controversial whether initial good results can be maintained over time. AMD is a chronic disease and a significant proportion of patients require continued treatment.


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