Real-World Results of Aflibercept versus Ranibizumab for the Treatment of Exudative AMD Using a Fixed Regimen

Intravitreal injections of antivascular endothelial growth factors have been considered a milestone in the treatment of neovascular age-related macular degeneration (nAMD). However, the increasing incidence of AMD and the burden of visits and injections overcharge both the patient and the healthcare systems. Real-world solutions depend on treatment protocols aimed at optimizing the number of clinical visits while guaranteeing good functional outcomes. We performed a retrospective analysis of 72 eyes from 63 naïve patients diagnosed with nAMD that underwent a fixed intravitreal protocol consisting of bimonthly injections after a three-month loading dose, with either Aflibercept or Ranibizumab (no predefined criteria for treatment selection). Best corrected visual acuity (BCVA) and optical coherence tomography were analyzed at baseline and during follow-up clinical visits (months 3, 6, 12, and 18). From the included participants, 42 followed a fixed regimen with Aflibercept and 30 with Ranibizumab. At the 12-month visit, there was not a statistically significant difference in the mean change of BCVA between the two groups (p=0.121); however, the mean difference in the central retinal thickness was significantly superior in the Aflibercept group (-142.2 versus -51.5, p=0.011). The described fixed regimen seems to be efficient in the treatment of nAMD in a clinical practice setting.

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Comparison of the Effectiveness and Prognostic Factors of Intravitreal Ranibizumab between Typical Neovascular Age-Related Macular Degeneration and Polypoidal Choroidal Vasculopathy over 24 Months of Follow-Up

Ophthalmologica ◽

10.1159/000431000 ◽

2015 ◽

Vol 234 (1) ◽

pp. 33-39 ◽

Cited By ~ 9

Author(s):

Wataru Matsumiya ◽

Shigeru Honda ◽

Keiko Otsuka ◽

Akiko Miki ◽

Takayuki Nagai ◽

...

Keyword(s):

Macular Degeneration ◽

Polypoidal Choroidal Vasculopathy ◽

Age Related Macular Degeneration ◽

Morphological Parameters ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

Age Related ◽

The Mean ◽

Choroidal Vasculopathy

Purpose: To compare the response to ranibizumab between patients with typical neovascular age-related macular degeneration (tAMD) and those with polypoidal choroidal vasculopathy (PCV), and to determine the predictors for the outcomes. Methods: Fifty-nine eyes from 59 consecutive patients (tAMD: 27 eyes, PCV: 32 eyes) were treated with three monthly ranibizumab injections followed by as-needed retreatment. Best-corrected visual acuity (BCVA) and morphological parameters were evaluated over 24 months of follow-up. Results: The mean BCVA in tAMD and PCV patients was significantly improved at 3 months (-0.22 and -0.09 logMAR units, respectively). The improvement in BCVA was sustained up to 24 months in tAMD (p = 0.01) but not in PCV patients. The significant predictor for good response to ranibizumab in tAMD patients was the improvement of BCVA at 3 months, whereas that in PCV patients was the anatomical resolution at 3 months. Conclusions: Ranibizumab is an effective therapy for tAMD and PCV over 24 months. The predictors for good outcome might be different between tAMD and PCV.

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Real-World Experience with Brolucizumab in Wet Age-Related Macular Degeneration: The REBA Study

Journal of Clinical Medicine ◽

10.3390/jcm10132758 ◽

2021 ◽

Vol 10 (13) ◽

pp. 2758

Author(s):

Alper Bilgic ◽

Laurent Kodjikian ◽

Francesc March de Ribot ◽

Vaishali Vasavada ◽

Jesus H. Gonzalez-Cortes ◽

...

Keyword(s):

Macular Degeneration ◽

Real World ◽

Age Related Macular Degeneration ◽

Secondary Outcome ◽

The Real ◽

Switch Therapy ◽

Age Related ◽

Treatment Naïve ◽

The Mean

The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters (p = 0.011) and +10.4 ± 4.8 letters (p = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive (p = 0.021) and the switch-therapy (p = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.

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Effects of Intravitreal Ranibizumab Injection on Chinese Patients with Wet Age-Related Macular Degeneration: 5-Year Follow-Up Results

Journal of Ophthalmology ◽

10.1155/2016/6538192 ◽

2016 ◽

Vol 2016 ◽

pp. 1-5

Author(s):

Yingyi Lu ◽

Jianfeng Huang ◽

Jing Zhao ◽

Xiaobing Yu ◽

Li Long ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Age Related Macular Degeneration ◽

Chinese Patients ◽

Intravitreal Ranibizumab ◽

Corrected Visual Acuity ◽

Age Related ◽

The Mean ◽

Number Of Injections

Purpose. To observe the effect of intravitreal ranibizumab injection on wet age-related macular degeneration (wAMD) over 5 years in Chinese patients. Methods. Thirty-seven patients who were diagnosed with wAMD in our hospital from June 2007 to June 2014 were retrospectively reviewed. The PRN regimen and the treatment and extend regimen were applied. Best corrected visual acuity (BCVA), number of ranibizumab injections, and changes in the choroidal neovascularization (CNV) lesion over 5 years were analyzed. Results. The mean BCVA measured by the ETDRS chart at baseline was 47.4 and 5 years after the treatment it was 34.89 letters, which was significantly different (p=0.013). Fourteen eyes (37.8%) had improved visual acuity after 5 years. The number of injections in 5 years was 11.53, and most of the injections were in the first two years. Seventeen (45.9%) cases developed fibrous lesions, and 2 (5.4%) cases had atrophic lesions after 5 years. The fibrosis/atrophy was significantly correlated with the injection numbers (Pearson, r=0.663, and p=0.000). Conclusion. Most of the patients can maintain visual acuity treated by ranibizumab in the first 3 years. After 5 years, some patients can still improve or maintain visual acuity. Fibrous scarring of the lesion is the main reason for a decrease in vision of wAMD patients.

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

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

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.

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

QJM ◽

10.1093/qjmed/hcaa058.011 ◽

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.

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Outcomes of coaxial microincision cataract surgery versus conventional phacoemulsification surgery

Asian Journal of Ophthalmology ◽

10.35119/asjoo.v16i3.458 ◽

2019 ◽

Vol 16 (3) ◽

pp. 168-178

Author(s):

Anu Malik ◽

Smruti Ranjan Dethi ◽

Yogesh Kumar Gupta ◽

Alka Gupta

Keyword(s):

Cataract Surgery ◽

Randomized Study ◽

Corrected Visual Acuity ◽

Age Related ◽

Significant Difference ◽

Induced Astigmatism ◽

The Mean ◽

Group 2 ◽

Surgically Induced ◽

Group 1

Aim: To compare surgical parameters and visual outcomes of coaxial microincision cataract surgery (MICS) with standard phacoemulsification. Methods: A prospective randomized study was conducted on 60 eyes of 60 patients with age-related uncomplicated cataract who underwent: standard phacoemulsification surgery (30 eyes) i.e., Group 1, or coaxial MICS (30 eyes) i.e., Group 2. Intraoperative parameters were mean effective phacoemulsification power (EPP), effective phacoemulsification time (EPT), and total volume of balanced salt solution (BSS) used. Best-corrected visual acuity (BCVA) and surgically induced astigmatism (SIA) were evaluated pre- and postoperatively. Results: Mean BCVA at 6 weeks was 0.04 ± 0.07 in Group 1 and 0.05 ± 0.08 in Group 2. No significant difference was observed in SIA between the two groups. Mean EPT was 29.80 ± 3.67 seconds in Group 1 and 31.93 ± 4.08 seconds in Group 2. The mean total EPP in Group 1 was 35.77 ± 5.17%, whereas it was 33.70 ± 3.05% in Group 2. There was a significant statistical difference between mean EPP and EPT in the two groups. Mean total BSS volume used in Group 1 was 128.83 ± 19.81 ml, whereas it was 139.33 ± 13.57 ml in Group 2. Conclusion: Although EPT and BSS volume used were significantly higher in coaxial MICS, the postoperative results of the two techniques were comparable.

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Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Journal of Ophthalmic and Vision Research ◽

10.18502/jovr.v16i1.8248 ◽

2021 ◽

Author(s):

Ahmad Mirshahi ◽

Alireza Lashay ◽

Hamid Riazi-Esfahani ◽

Nazanin Ebrahimiadib ◽

Hassan Khojasteh ◽

...

Keyword(s):

Macular Edema ◽

Intravitreal Injection ◽

Case Series ◽

Age Related Macular Degeneration ◽

Intraocular Injection ◽

Vein Occlusion ◽

Corrected Visual Acuity ◽

Age Related ◽

Limited Experience ◽

The Mean

Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®. Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection. Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively. Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.

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Association between Retinal Thickness Variability and Visual Acuity Outcome during Maintenance Therapy Using Intravitreal Anti-Vascular Endothelial Growth Factor Agents for Neovascular Age-Related Macular Degeneration

Journal of Personalized Medicine ◽

10.3390/jpm11101024 ◽

2021 ◽

Vol 11 (10) ◽

pp. 1024

Author(s):

Timothy Y. Y. Lai ◽

Ricky Y. K. Lai

Keyword(s):

Visual Acuity ◽

Retinal Thickness ◽

Age Related Macular Degeneration ◽

Vascular Endothelial ◽

Anti Vegf ◽

Age Related ◽

Thickness Variability ◽

The Mean ◽

Endothelial Growth Factor

Previous studies based on clinical trial data have demonstrated that greater fluctuations in retinal thickness during the course of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD) is associated with poorer visual acuity outcomes. However, it was unclear whether similar findings would be observed in real-world clinical settings. This study aimed to evaluate the association between retinal thickness variability and visual outcomes in eyes receiving anti-VEGF therapy for nAMD using pro re nata treatment regimen. A total of 64 eyes which received intravitreal anti-VEGF therapy (bevacizumab, ranibizumab or aflibercept) for the treatment of nAMD were evaluated. Variability in spectral-domain optical coherence tomography (OCT) central subfield thickness (CST) was calculated from the standard deviation (SD) values of all follow-up visits after three loading doses from month 3 to month 24. Eyes were divided into quartiles based on the OCT CST variability values and the mean best-corrected visual acuity values at 2 years were compared. At baseline, the mean ± SD logMAR visual acuity and CST were 0.59 ± 0.39 and 364 ± 113 µm, respectively. A significant correlation was found between CST variability and visual acuity at 2 years (Spearman’s ρ = 0.54, p < 0.0001), indicating that eyes with lower CST variability had better visual acuity at 2 years. Eyes with the least CST variability were associated with the highest mean visual acuity improvement at 2 years (quartile 1: +9.7 letters, quartile 2: +1.1 letters, quartile 3: −2.5 letters, quartile 4: −9.5 letters; p = 0.018). No significant difference in the number of anti-VEGF injections was found between the four CST variability quartile groups (p = 0.21). These findings showed that eyes undergoing anti-VEGF therapy for nAMD with more stable OCT CST variability during the follow-up period were associated with better visual outcomes. Clinicians should consider adopting treatment strategies to reduce CST variability during the treatment course for nAMD.

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Efficacy Comparison of Intravitreal Anti-VEGF Therapy for Three Subtypes of Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis

Journal of Ophthalmology ◽

10.1155/2018/1425707 ◽

2018 ◽

Vol 2018 ◽

pp. 1-10 ◽

Cited By ~ 4

Author(s):

Jianqing Li ◽

Jiayi Xu ◽

Yiyi Chen ◽

Jiaju Zhang ◽

Yihong Cao ◽

...

Keyword(s):

Systematic Review ◽

Macular Degeneration ◽

Meta Analysis ◽

Age Related Macular Degeneration ◽

Cochrane Library ◽

Anti Vegf ◽

Age Related ◽

Significant Difference ◽

The Mean

Purpose. Intravitreal antivascular endothelial growth factor (anti-VEGF) therapy has been widely used for the treatment of neovascularization (NV) secondary to age-related macular degeneration (AMD). This study aimed to compare the efficacy among different subtypes of neovascular age-related macular degeneration (nAMD). Methods. PubMed, Embase, and the Cochrane Library were searched for eligible studies. We performed meta-analysis using Review Manager 5.3 and Stata/SE 12.0. Results. A total of 24 studies met our inclusion criteria and were included in the systematic review. At 3 months, the mean logarithm of the minimum angle of resolution (logMAR) improvements were −0.09, −0.18, and −0.23 for type 1, 2, and 3, respectively, while the mean macular thickness (MT) changes were −104.83, −130.76, and −196.29 μm. At 12 months, the mean changes in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters were 6.38, 8.12, and 9.37, while the MT decrease was 126.51, 126.52, and 139.85 μm, respectively. However, statistically significant difference was only found between type 1 and 3 in vision improvement, both in the short term (p=0.0002) and long term (p=0.01). Conclusions. The reactivity to VEGF inhibitors varied among different subtypes of nAMD. The efficacy of intravitreal anti-VEGF therapy in type 3 nAMD was statistically better than type 1 when considering vision improvement at 3 and 12 months. Thus, the lesion subtype is a predictor for the treatment outcome which can help guide prognosis.

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Questionnaire Survey on Driving among Patients with Age-Related Macular Degeneration in Japan

Journal of Clinical Medicine ◽

10.3390/jcm10214845 ◽

2021 ◽

Vol 10 (21) ◽

pp. 4845

Author(s):

Chikako Hara ◽

Miki Sawa ◽

Fumi Gomi ◽

Kohji Nishida

Keyword(s):

Macular Degeneration ◽

Age Related Macular Degeneration ◽

University Hospital ◽

Corrected Visual Acuity ◽

Age Related ◽

Paracentral Scotoma ◽

The Mean ◽

The Right ◽

The Relationship ◽

Car Driving

Purpose: This study aimed to assess driving capabilities in patients with exudative age-related macular degeneration (AMD) causing unilateral blindness or paracentral scotoma without vision deterioration. Methods: Of the 275 patients with AMD who responded to a questionnaire regarding car driving at Osaka University Hospital, we excluded 78 patients who answered that they had never driven. Finally, 197 patients were included (50 with bilateral and 142 with unilateral AMD). We investigated the relationship between the questionnaire findings and best-corrected visual acuity (BCVA). Results: The mean age was 74.8 ± 6.9 years, and the mean BCVA in the right and left eyes were 0.48 and 0.47, respectively. A negative correlation was observed between the proportion of patients who stopped driving due to AMD and the vision in the worse eye (p < 0.0001); however, 66% of participants were still driving. Regardless of the BCVA, 84% of them wished to continue driving. Concerning perceived dangerous situations, all patients reported an oversight of people or signals and night driving; further, patients with unilateral and bilateral vision deterioration reported vision narrowness and difficulty with discerning signal colours, respectively. Conclusion: Despite the associated danger, patients with AMD continued driving. Close attention should be paid to the driving activities among patients with AMD, even if they have passed the relevant driving tests.

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