scholarly journals Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study

2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Safety Data ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Clinical Practices ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean ◽  
Wet Amd

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.

scholarly journals Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sam Razavi ◽  
Laurent Kodjikian ◽  
Audrey Giocanti-Aurégan ◽  
Ingrid Dufour ◽  
Eric Souied
Keyword(s):  
Macular Degeneration ◽  
Treatment Success ◽  
Safety Data ◽  
Common Adverse Event ◽  
Age Related Macular Degeneration ◽  
Link Type ◽  
Anti Vegf ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean

Abstract Background Anti–vascular endothelial growth factor (anti-VEGF) agents have become the standard of care in neovascular age-related macular degeneration (nAMD). Despite generally excellent response rates to anti-VEGF therapy, some patients do not respond or may respond suboptimally. In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch to another anti-VEGF agent. TITAN was an observational study that assessed the effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with nAMD refractory to ranibizumab who switched to IVT-AFL after less than 12 months of ranibizumab treatment in routine clinical practice in France. Methods TITAN was an observational, retrospective and prospective 12-month study conducted at 28 centres in France. Patients with nAMD refractory to ranibizumab were enrolled. Patients who were switched from ranibizumab to IVT-AFL were followed for 12 months. Data were obtained from medical records for retrospectively included patients, and at routine follow-up visits for those included prospectively. The main outcome measure was percentage of patients who achieved treatment success (gain of ≥1 Early Treatment Diabetic Retinopathy Study letters in best-corrected visual acuity [BCVA] and/or any reduction in central retinal thickness [CRT]) from baseline to 12 months after switching. A sample size of 225 patients was determined based on a 2-sided 95% confidence interval with a width equal to 0.12 when the sample proportion was 0.70. Results We analysed safety data (N = 217) and clinical outcomes from patients in the per-protocol population (n = 125). The mean (standard deviation) number of IVT-AFL injections was 7.5 (2.6). Treatment success was achieved in 68.8% of patients. Mean BCVA change from baseline to Month 12 was + 1.5 letters (P = 0.105) and the mean CRT change was − 45.0 μm (P <  0.001). In a subgroup analysis, in patients who received three initial monthly IVT-AFL injections, mean BCVA gain was 3.3 letters at Month 12 (P = 0.015). Excluding lack of efficacy and inappropriate scheduling of drug administration, the most common adverse event was eye pain (2.3%). Conclusions Switching ranibizumab-refractory patients with nAMD to IVT-AFL may improve visual outcomes in some patients, particularly those who receive three initial monthly injections. Trial registration ClinicalTrials.gov, NCT02321241. First posted: December 22, 2014; Last update posted: July 2, 2018

scholarly journals Visual acuity dynamics after phacoemulsification in patients with “wet” form of age-related macular degeneration, treated by intravitreal angiogenesis inhibitor injections

2013 ◽  
Vol 6 (1) ◽  
pp. 44-50 ◽  
Author(s):  
Natalya Viktorovna Chistyakova ◽  
Yuriy Sergeevich Astakhov ◽  
Nikita Yuryevich Dal
Keyword(s):  
Visual Acuity ◽  
Cataract Surgery ◽  
Macular Degeneration ◽  
Angiogenesis Inhibitor ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
The Mean ◽  
The Difference ◽  
Group 2 ◽  
Wet Amd

Design: prospective non-randomized experimental longitudinal cohort study. The aim of the study: to evaluate the visual acuity after phacoemulsification in patients with the “wet” form of age-related macular degeneration, treated by intravitreal angiogenesis inhibitor injections. Materials: 48 patients (48 eyes) with the “wet” form of AMD, treated by intravitreal angiogenesis inhibitor injections, and incipient cataract. All eyes in the study had a diagnosis of “wet” AMD and underwent cataract surgery. They were followed for a minimum of two years after the cataract surgery. The mean age of patients was 78.16 ± 5 years. There were 36 female (75 %) and 12 male (25 %) patients. Results: All patients were retrospectively divided into two groups. Group No. 1 consisted of 23 patients — operated within a year of the diagnosis of “wet” AMD, and group No. 2 which consisted of 25 patients who had a diagnosis of “wet” AMD for longer than one year prior to the cataract surgery. The mean preoperative visual acuity in the 1st group was 0.16 ± 0.07 (median 0.15), and in patients of group 2 — 0.23 ± 0.06 (median 0,2). Mean visual acuity immediately before surgery in the 1st group was 0.13 ± 0.04 (median 0.09), in the 2nd group — 0.12 ± 0.04 (median 0,08). After surgery, in the 1st group, mean visual acuity was — 0.28 ± 0.08 (median 0.25), in the 2nd group —0.18 ± 0.07 (median 0,15). The difference between the two groups was statistically significant, p < 0.01, t-test. Statistically significant visual acuity increase after surgery was registered in both groups and was preserved after one and two years, when compared to the data before surgery: for the 1st group — 0.13 and 0.1; for the 2nd group — 0,1 and 0.07, respectively (p < 0,01, Wilcoxon criterion). Conclusions: Phacoemulsification is reasonable for eyes with the “wet” form of age-related macular degeneration. Patients with shorter “wet” AMD duration obtain a higher visual acuity increase after cataract surgery. Statistically significant visual acuity increase after surgery is preserved in the majority of patients during next 2 years of follow-up.

scholarly journals Effect of Ranibizumab Treatment in Cases of Choroidal Neovascular Membranes Secondary to Pathological Myopia versus Age-Related Macular Degeneration

QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
M S Abdaltawab ◽  
Z F Ismail ◽  
W M A Ebeid ◽  
S M Fawzy
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
P Value ◽  
Newly Diagnosed ◽  
Pathological Myopia ◽  
Age Related ◽  
Significant Difference ◽  
The Mean

Abstract Aim of the Work The aim of this work is to compare the response of treatment with ranibizumab in terms of visual acuity in cases of CNV secondary to pathological myopia versus CNV secondary to age-related macular degeneration. Methods This prospective, comparative study included ten eyes newly diagnosed as having CNV secondary to pathological myopia, and 10 eyes newly diagnosed as having subfoveal active CNV secondary to AMD. All patients had 3 monthly intravitreal Injections of 0.50 mg (in 0.05 ml of solution) ranibizumab with monthly evaluation of best corrected visual acuity (BCVA) by Landolt C chart, and also calculated in Logarithm of Minimum Angle of Resolution (Log MAR). Results pretreatment there was no significant difference between the two groups as the mean VA (Log Mar) was 1.31 ± 0.2 in AMD group and 1.17 ± 0.3 in MCNV group of P value = 0.431 and also post three IVI of ranibizumab showed no significant difference between the two groups as the mean VA (Log Mar) was 1.22 ± 0.2 for AMD and 1.22 ± 0.5 for MCNV of P value = 0.635. Conclusion there was no significant difference in BCVA between AMD and MCNV groups after three intravitreal injections of ranibizumab.

scholarly journals Baseline Characteristics of the Fellow Eye in Patients with Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the VIEW Studies

2016 ◽  
Vol 236 (2) ◽  
pp. 95-99 ◽  
Author(s):  
Sebastian Wolf ◽  
Francesco Bandello ◽  
Anat Loewenstein ◽  
Jason Slakter ◽  
Todd Katz ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Fellow Eye ◽  
Post Hoc Analysis ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Baseline Characteristics ◽  
Post Hoc ◽  
Fellow Eyes

Purpose: The aim was to describe baseline characteristics of the fellow eye of patients with neovascular age-related macular degeneration (nAMD). Methods: A pooled, post hoc analysis of patients with nAMD enrolled in the VIEW studies was carried out. The VIEW studies compared intravitreal aflibercept (monthly or every 2 months after 3 monthly injections) with monthly ranibizumab. Baseline choroidal neovascularization (CNV) status of fellow eyes and baseline best-corrected visual acuity (BCVA) and lens status of all eyes were evaluated. Additional analyses evaluated the presence of drusen and pigment in fellow eyes. Results: When comparing both eyes, baseline BCVA was worse in 23.8% of fellow eyes and in 75.2% of study eyes. Lens status of fellow eyes and study eyes was similar. Baseline visual acuity of the study eye and that of the fellow eye were not correlated. Most fellow eyes had signs of early AMD, with 34.6% (n = 843) of fellow eyes having evidence of scarring. Conclusions: In patients in the VIEW studies, most fellow eyes had evidence of AMD, highlighting the importance of examining both eyes, with close follow-up thereafter, in order to detect and treat CNV earlier as needed.

scholarly journals Limited Treatment Response during Follow-up after Switching to Aflibercept in Neovascular Age-related Macular Degeneration

2021 ◽  
Vol 62 (9) ◽  
pp. 1218-1226
Author(s):  
Gon Soo Choe ◽  
Jong Woo Kim ◽  
Chul Gu Kim ◽  
Jae Hui Kim
Keyword(s):  
Visual Acuity ◽  
Retrospective Study ◽  
Macular Degeneration ◽  
Treatment Response ◽  
Visual Outcome ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Age Related ◽  
The Mean

Purpose: To investigate the limited response to aflibercept after switching to aflibercept in neovascular age-related macular degeneration (AMD). Methods: This retrospective study included 70 eyes with neovascular AMD that were initially treated with ranibizumab and then switched to aflibercept. The incidence and timing of the limited response to aflibercept were identified and visual outcome was compared between eyes with and without limited response. In addition, factors predictive of limited response were analyzed. Results: A limited response to aflibercept was noted in approximately 1/5 of the patients who underwent switching to aflibercept in neovascular AMD. Switching to aflibercept was performed at a mean of 16.2 ± 12.7 months after diagnosis. During the mean 34.7 months of follow-up after switching, limited response was noted in 15 eyes (21.4%) at a mean of 22.0 ± 13.9 months after switching. The degree of reduction in visual acuity was mean logMAR 0.34 ± 0.41 in eyes with limited response and mean 0.06 ± 0.20 in eyes without (p = 0.002). In addition, the duration between the diagnosis and the switching was shorter (p = 0.012), and the number of ranibizumab injections before switching was lower (p = 0.016) in eyes with limited response than in eyes without. Conclusions: Patients who showed limited response to aflibercept after switching to aflibercept showed a worse visual outcome. The probability of having a limited response is higher when the switching is performed earlier.

scholarly journals Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

2019 ◽  
Vol 104 (1) ◽  
pp. 64-73
Author(s):  
Francesco Bandello ◽  
Giovanni Staurenghi ◽  
Federico Ricci ◽  
Edoardo Midena ◽  
Francesco Viola ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Risk Period ◽  
The Mean ◽  
Low Incidence ◽  
To Receive ◽  
Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

Fellow-Eye Conversion and Treatment in Exudative Age-Related Macular Degeneration

2019 ◽  
Vol 3 (6) ◽  
pp. 438-444
Author(s):  
Eliot R. Dow ◽  
Jennifer O. Adeghate ◽  
Peter G. Coombs ◽  
Mrinali Gupta Patel ◽  
Donald J. D’Amico ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Initial Diagnosis ◽  
Age Related Macular Degeneration ◽  
Fellow Eye ◽  
Visual Outcomes ◽  
Anti Vegf ◽  
Age Related ◽  
Wet Amd ◽  
Fellow Eyes

Purpose: This article assesses anatomical and visual outcomes after intravitreal antivascular endothelial growth factor (anti-VEGF) treatment in fellow eyes with wet age-related macular degeneration (AMD). Methods: A retrospective chart review was conducted of 349 patients diagnosed with wet AMD between 2005 and 2017 at a single academic institution. Initial diagnosis of unilateral wet AMD and a minimum follow-up time of 1 year after diagnosis were required for inclusion. Individuals were excluded if the initial diagnosis of wet AMD was made at an outside institution, if they had received prior treatment at another institution, or if they had bilateral wet AMD at the time of inclusion. Best-corrected visual acuity, optical coherence tomography (OCT) parameters, and frequency and type of intravitreal anti-VEGF injections were recorded. MedCalc Statistical Software version 17.6 (MedCalc Software) and GraphPad Software (GraphPad Software, Inc) were used for statistical analysis. Results: Of the 349 patients with wet AMD, 192 were included in the study (55%). Of these, 47 (24.5%) developed wet AMD in the fellow eye. The average time to second-eye conversion was 2.6 years, with fellow-eye conversion more likely to occur after 2 years of unilateral disease. On average, patients received 2.16 fewer injections per year in the fellow eye compared with the initially diagnosed eye ( P = .03), and fellow eyes tended to have better OCT results after 12 months of treatment. In addition, compared with ranibizumab and bevacizumab, aflibercept injections appeared to improve visual acuity both in initially diagnosed and fellow eyes. Conclusions: Exudative AMD in the fellow eye has a decreased treatment burden and better visual outcomes compared with the initial eye, which may be attributed to more frequent surveillance and early diagnosis.

Comparison of Visual Acuity and Central Macular Thickness in Neovascular Age-related Macular Degeneration Patients with Subretinal and Intraretinal Fluid Treated with Intravitreal Bevacizumab

2019 ◽  
Vol 45 (1) ◽  
pp. 20
Author(s):  
Novia Rahayu ◽  
Elvioza Elvioza ◽  
Aria Kekalih
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Intravitreal Bevacizumab ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Central Macular Thickness ◽  
Neovascular Amd ◽  
Age Related ◽  
Bevacizumab Treatment ◽  
Intraretinal Fluid

Purpose: To compare visual acuity (VA) and central macular thickness (CMT) outcome of loading dose intravitreal bevacizumab treatment between neovascular AMD patients with character of predominant subretinal and intraretinal fluid. Methods: Prospective study of loading dose intravitreal bevacizumab treated age-related macular degeneration, of which has a baseline macular morphology of subretinal or intraretinal fluid. VA, CMT, and their changes were evaluated during and after loading dose was completed. Results: Thirty eight eyes (38 patients, mean age 66,95 years) were enrolled. 20 eyes were in subretinal fluid (SRF group) and 18 intraretinal fluid (IRF) group. Mean VA at baseline eventually was significantly different where SRF group (56,41 letters) were better than IRF group (43,72 letters). No statistically significant difference of mean VA change or CMT change between group, however VA in SRF group remained higher and CMT in SRF group were lower than IRF group. Conclusion: Neovascular AMD, with both SRF and IRF at baseline, benefits from loading dose intravitreal bevacizumab treatment although mean visual acuity and mean central retinal thickness are better in those with SRF.

scholarly journals Macular Hole Surgery in the Case of Wet Age-Related Macular Degeneration Treated with Intravitreal Aflibercept

2019 ◽  
Vol 10 (3) ◽  
pp. 369-373 ◽  
Author(s):  
Agnieszka Nowosielska
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Macular Hole ◽  
Internal Limiting Membrane ◽  
Age Related Macular Degeneration ◽  
Internal Limiting Membrane Peeling ◽  
Age Related ◽  
Full Thickness Macular Hole ◽  
Intravitreal Aflibercept ◽  
Observation Period

A 72-year-old male treated with aflibercept (Eylea) due to choroidal neovascularization (CNV) in his left eye developed a full-thickness macular hole (MH) after the second injection. The occurrence of MH in his left eye resulted in further visual acuity deterioration. As a consequence of having developed the MH, the patient was operated on. Phacoemulsification and vitrectomy with internal limiting membrane peeling and 20% SF6 tamponade were performed. MH closure was achieved and best corrected visual acuity improved to the extent allowed by CNV. The patient continued anti-VEGF treatment with Eylea due to wet age-related macular degeneration in his left eye. The observation period of 2 years has been uneventful and visual acuity of 0.2 has remained stable.

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