scholarly journals Visual and anatomical outcomes associated with treat-and-extend administration of intravitreal aflibercept for neovascular age-related macular degeneration

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Mohamed Kamel Soliman ◽  
Nicolas Tuli ◽  
Thomas K. Lee ◽  
William A. Britton ◽  
Raman Tuli
Keyword(s):  
Macular Degeneration ◽  
Subretinal Fluid ◽  
Retrospective Chart Review ◽  
Age Related Macular Degeneration ◽  
Treat And Extend ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Anatomical Outcomes

Abstract Purpose To investigate the visual and anatomical outcomes associated with treat-and-extend (TAE) regimen of intravitreal (IVT) aflibercept in eyes with treatment naïve neovascular age-related macular degeneration (nvAMD). Methods A retrospective chart review of eyes that underwent IVT aflibercept injections for nvAMD between May 2014 and March 2018 was performed. The primary outcome was the change in best corrected visual acuity (BCVA) at 12 months. Secondary outcomes included the change in central retinal thickness (CRT), subretinal fluid (SRF) and intraretinal fluid (IRF). Results Data from 213 eyes of 213 patients (138 female, 65%) met the inclusion criteria. The mean (SD) age of the patients was 80.4 (±  9.2) years. The mean baseline BCVA (0.92  ±  0.50 logMAR, improved by 0.20 (±  0.40) logMAR units at 12 months (p  <  0.001). Seventy-two (34%) eyes gained  ≥  0.3 logMAR and 47 (22%) eyes achieved BCVA  ≤  0.3 logMAR at 12 months. Baseline BCVA, patient age, and the number of aflibercept injections received were predictors of the change in BCVA at 12 months. Mean CRT improved from 347 (±  117) µm at baseline to 246 (±  55) µm at 12 months (p  <  0.001). The percentage of eyes with SRF and IRF on SD-OCT declined from 63 to 21% and from 60 to 26% at 12 months, respectively. Conclusion A TAE regimen of IVT aflibercept in treatment naïve nvAMD is associated with good visual and anatomical outcomes in routine clinical practice. Resolution of exudation occurred in about half of nvAMD cases at 12 months. Individualized administration of IVT aflibercept may reduce injection burden.

scholarly journals Tolerating subretinal fluid in the treatment of neovascular age-related macular degeneration with intravitreal aflibercept

2021 ◽  
Vol 13 ◽  
pp. 251584142110228
Author(s):  
Dilan Yildiz ◽  
Akin Cakir ◽  
Burak Erden ◽  
Selim Bolukbasi ◽  
Serkan Erdenöz ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Subretinal Fluid ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Intensive Treatment Group ◽  
Significant Difference ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Change In The Mean ◽  
The Mean

Objective: To compare the anatomical and functional outcomes of intensive and relaxed intravitreal aflibercept regimen in the management of neovascular age-related macular degeneration. Methods: The medical records of 50 eyes of 50 patients with treatment-naive neovascular age-related macular degeneration, who underwent intravitreal aflibercept therapy in the Retinal Department of University of Health Sciences Okmeydanı Training and Research Hospital (Istanbul, Turkey), were retrospectively reviewed. The demographic features and best-corrected visual acuities at baseline and at 1st-, 2nd-, 3rd-, 4th-, 6th-, 10th- and 12th- months, optical coherence tomography measurements, presence of intraretinal fluid, subretinal fluid and intraocular pressure values were studied. The patients were divided into two groups: intensive (subretinal fluid intolerant) and relaxed (<200 microns subretinal fluid tolerated) intravitreal aflibercept regimens. Results: The change in the mean best-corrected visual acuities from baseline to 12th month was 13.72 ± 33.97 letters in the intensive treatment group and 8.68 ± 27.22 in the relaxed group. There was no statistically significant difference between the groups ( p = 0.566). Similar proportions of both groups achieved ⩾10 letters gain (%48 vs. %40, respectively; p = 0.755) and ⩾10 letters loss (%20 vs. %24, respectively; p = 0.755). The mean central subfield thickness values decreased statistically significantly in both groups ( p < 0.001). There was no statistically significant difference between the groups (442.40 ± 161.32 to 318.0 ± 63.10 vs. 431.64 ± 151.52 to 303.08 ± 140.91, respectively; p = 0.724). The mean total injection numbers were significantly lower in the relaxed group (6.4 ± 1.65 vs. 4.8 ± 1.45, respectively; p = 0.01). Conclusion: Relaxed intravitreal aflibercept regimen has comparable efficiency and safety outcomes at 12 months with intensive intravitreal aflibercept regimen with fewer injections in the management of neovascular age-related macular degeneration.

Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

2021 ◽  
pp. 112067212110057
Author(s):  
Pierre Gascon ◽  
Prithvi Ramtohul ◽  
Charles Delaporte ◽  
Sébastien Kerever ◽  
Danièle Denis ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real Life ◽  
Age Related Macular Degeneration ◽  
Cumulative Number ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Treatment Naïve ◽  
The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

scholarly journals Two-year outcomes of intravitreal aflibercept in a Swiss routine treat and extend regimen for patients with neovascular age-related macular degeneration

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Andreas Ebneter ◽  
Stephan Michels ◽  
Christian Pruente ◽  
Pascal Imesch ◽  
Felix Eilenberger ◽  
...  
Keyword(s):  
Real Life ◽  
Age Related Macular Degeneration ◽  
Routine Practice ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Treat And Extend Regimen

AbstractThe aim of this observational study was to assess the use and outcome of intravitreal aflibercept in a treat and extend regimen in treatment-naïve neovascular AMD patients in routine practice. This both retrospective and prospective study was conducted in four larger Swiss retina clinics (ASTERIA study). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in ETDRS letters from baseline to 12 months. Between December 2017 and August 2018, 160 patients were included. For patients with available data, the mean change in BCVA was + 8.4 (± 14.4) letters at month 12 (n = 139) and + 5.0 (± 11.4) letters at month 24 (n = 95). A mean number of 8.3 (± 2.4) injections were administered within the first year and 5.4 (± 2.9) injections during the second year. On average, the observed treatment interval at month 12 was 63.3 (± 22.0) days and increased to 69.1 (± 28.6) days at month 24. For 37% of the patients, a treatment interval ≥ 12 weeks was attained at month 24. In conclusion,  intravitreal aflibercept in a Swiss real-life treat and extend regimen resulted in comparable anatomic and functional outcomes as were observed in the prospective registration trials of aflibercept for nAMD treatment.

scholarly journals Four-year outcomes of intravitreal aflibercept treatment for neovascular age-related macular degeneration using a treat-and-extend regimen in Japanese patients

2021 ◽  
Vol 13 ◽  
pp. 251584142098458
Author(s):  
Koki Ishibashi ◽  
Masatoshi Haruta ◽  
Yumi Ishibashi ◽  
Rie Noda ◽  
Shotaro Dake ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Japanese Patients ◽  
Age Related Macular Degeneration ◽  
Rank Test ◽  
Neovascular Amd ◽  
Treat And Extend ◽  
Treatment Interval ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
The Mean

Objective: The purpose of our study was to determine the 4-year visual and anatomic outcomes of intravitreal aflibercept treatment for neovascular age-related macular degeneration (AMD) using a treat-and-extend (TAE) regimen. Methods: We retrospectively reviewed the medical records of 39 patients with neovascular AMD who were treated continuously with intravitreal aflibercept injections using the TAE regimen for at least 4 years. The outcome measures were the best-corrected visual acuity (BCVA) and central macular thickness (CMT) on spectral-domain optical coherence tomography. The BCVAs were measured as decimal values and converted to the corresponding Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores for statistical analysis. The Wilcoxon signed-rank test was used to compare the differences in BCVAs and CMTs. Results: The mean ETDRS letter scores improved significantly from 63.9 at baseline to 70.4, 67.8, 67.2, and 67.3 at 1, 2, 3, and 4 years, respectively. The mean baseline CMT was 380 µm, which decreased significantly to 229, 231, 221, and 210 µm at 1, 2, 3, and 4 years, respectively. The mean numbers of injections were 7.9, 6.0, 5.5, and 5.4 at 1, 2, 3, and 4 years, respectively. The percentages of patients with a treatment interval of 12 weeks or more were 46.2%, 46.2%, 43.6%, and 46.2% at 1, 2, 3, and 4 years, respectively. At year 4, 30.8% of the patients had a treatment interval of 7 weeks or less, whereas 25.6% had 16 weeks or more. Conclusion: Intravitreal aflibercept TAE treatment may be an effective and efficient method for treating patients with neovascular AMD up to 4 years of follow-up. The TAE regimen is a potential tool to optimize appropriate treatment intervals, avoiding both undertreatment and overtreatment of neovascular AMD.

scholarly journals PERSEUS 24-month analysis: a prospective non-interventional study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Germany in patients with neovascular age-related macular degeneration

2021 ◽  
Author(s):  
Nicole Eter ◽  
◽  
Zoran Hasanbasic ◽  
Georgios Keramas ◽  
Christine Rech ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Primary Endpoint ◽  
Age Related Macular Degeneration ◽  
Interventional Study ◽  
Regular Treatment ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
The Mean

Abstract Purpose To evaluate the real-world effectiveness of intravitreal aflibercept injections in Germany in patients with neovascular age-related macular degeneration over 24 months. Methods PERSEUS was a prospective, non-interventional cohort study. The primary endpoint was the mean change in visual acuity (VA) from baseline. Secondary endpoints included the proportion of patients with a VA gain or loss of ≥ 15 letters and the frequency of injections and examinations. Patients with regular (bimonthly after 3 monthly injections during year 1 and ≥ 4 injections in year 2) and irregular (any other) treatment were analyzed. The last observation carried forward (LOCF) and the observed cases (OC) approach was applied for primary endpoint analysis to account for missing data. Results 803 patients were considered for effectivity analysis. At month 24, only 38% of the patients were still under observation. The LOCF population included 727, the OC population 279 patients. Treatment-naïve patients improved by 6.3 (LOCF)/8.1 (OC) letters with regular treatment over 24 months but only by 3.3 (LOCF)/3.1 (OC) letters with irregular treatment. The proportion of treatment-naïve patients achieving a VA improvement of ≥ 15 letters was similar between regularly and irregularly treated cohorts. However, considerably more patients in the irregular cohorts experienced a VA worsening of ≥ 15 letters than in the regular cohorts (LOCF: 18.7% vs. 7.4%). Conclusions Regular IVT-AFL treatment resulted in better VA outcomes than irregular treatment at month 24. However, only a minority of patients received regular treatment over a 2-year period.

scholarly journals Aflibercept for age-related macular degeneration: 4-year outcomes of a ‘treat-and-extend’ regimen with exit-strategy

2020 ◽  
pp. bjophthalmol-2020-316514
Author(s):  
Damian Jaggi ◽  
Thanoosha Nagamany ◽  
Andreas Ebneter ◽  
Marion Munk ◽  
Sebastian Wolf ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Long Term Outcomes ◽  
Treat And Extend ◽  
Age Related ◽  
Central Subfield Thickness ◽  
Treatment Naïve ◽  
Treat And Extend Regimen

AimTo report long-term outcomes on best-corrected visual acuity (BCVA) and treatment intervals with a treat-and-extend (T&E) regimen in patients with neovascular age-related macular degeneration (nAMD).MethodsThis observational study included treatment-naïve patients with nAMD, treated with aflibercept. A specific T&E protocol without a loading phase and predefined exit criteria was administered. After reaching predefined ‘exit-criteria’, the treatment period was complete, and patients were observed three monthly.ResultsEighty-two patients with a follow-up period of ≥2 years were included. BCVA (mean±SD, ETDRS letters) increased from 51.9±25.2 at baseline to 63.7±17.7 (p<0.0001) at 1 year, 61.7±18.5 (p<0.0001) at 2 years, 62.4±19.5 (p<0.0001, n=61) at 3 years and remained insignificantly higher than baseline at 4 years at 58.5±24.3 (p=0.22). Central subfield thickness (mean±SD, μm) decreased significantly from 387.5±107.6 (p<0.0001) at baseline to 291.9±65.5 (p<0.0001) at 1 year, and remained significantly lower until 4 years at 289.0±59.4 (p<0.0001). Treatment intervals (mean±SD, weeks) could be extended up to 9.3±3.1 weeks at 1 year and remained at 11.2±3.5 weeks at 4 years. Twenty-nine (35%) patients reached exit criteria and continued with three monthly observation only.ConclusionsAfter 4 years of treatment, initial vision gains were maintained with a reasonable treatment burden, even without an initial loading phase. Our results on functional outcomes are comparable with large controlled studies.

scholarly journals A Case of Sustained Intraocular Pressure Elevation after Multiple Intravitreal Injection of Ranibizumab and Aflibercept for Neovascular Age-Related Macular Degeneration

2016 ◽  
Vol 7 (1) ◽  
pp. 230-236 ◽  
Author(s):  
Hisashi Matsubara ◽  
Ryohei Miyata ◽  
Maki Kobayashi ◽  
Hideyuki Tsukitome ◽  
Kengo Ikesugi ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Macular Degeneration ◽  
Subretinal Fluid ◽  
Age Related Macular Degeneration ◽  
Intravitreal Injections ◽  
Multiple Injections ◽  
Anti Vegf ◽  
Age Related ◽  
Intravitreal Aflibercept ◽  
Iop Elevation

Intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents are widely used to treat neovascular age-related macular degeneration (nAMD). Although these treatments are effective, multiple injections have recently been recommended to ensure that there is a good long-term prognosis. However, sustained intraocular pressure (IOP) elevations have been reported to develop after multiple injections of anti-VEGF agents. We present our findings of a case of uncontrolled and persistent IOP elevation after switching from intravitreal ranibizumab injections to intravitreal aflibercept injections. A 74-year-old Japanese man without a history of glaucoma underwent 22 ranibizumab injections for nAMD and suddenly developed an elevated IOP after the 22nd injection. Although the subsequent medical treatment led to normalization of his IOP, the subretinal fluid under the central fovea remained even after the 25th injection of ranibizumab. Thus, ranibizumab treatment was switched to bimonthly intravitreal aflibercept injections in conjunction with glaucoma medications. His IOP recovered to within the normal range; however, after the 11th aflibercept injection, there was a sudden elevation of his IOP in spite of the continued glaucoma medications. Due to this sustained IOP elevation, his aflibercept injections were suspended for 16 weeks. Because his IOP could not be normalized by a full glaucoma medication regimen, the patient underwent trabeculotomy, which resulted in a lowering of the IOP to normal levels. We conclude that patients who receive serial intravitreal injections of anti-VEGF agents need to be closely monitored because severe and sustained ocular hypertension can develop.

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