One-year outcomes of the Polish treatment program for the wet form of age-related macular degeneration using intravitreal therapy

2020 ◽  
Vol 30 (3) ◽  
pp. 586-594
Author(s):  
Małgorzata Figurska ◽  
Anna Matysik-Wożniak ◽  
Joanna Adamiec-Mroczek ◽  
Joanna Dolar-Szczasny ◽  
Marta Misiuk-Hojło ◽  
...  

Purpose: To report 12-month outcomes of a Polish National Treatment Program using aflibercept and ranibizumab in eyes with wet, age-related macular degeneration in routine clinical practice. Material and Methods: This was a non-randomized, retrospective, observational multicenter study. Anonymous data contained in the electronic Therapeutic Program Monitoring System were utilized in this study. Results: The study population consisted of 2828 eyes from 2718 patients. The median age was 76.0 [70.0, 81.0] years; 61.7% were female. Best corrected visual acuity increased from 58.86 [50.05, 69.95] letters to 65.1 [50.1, 73.9] letters (p < 0.001). The median change in best corrected visual acuity was 0.0 [−4.0, 12.2] letters: 2.9 [−2.9, 15.1] letters for treatment-naïve eyes and 0.0 [−4.0, 8.8] letters for those continuing treatment (p < 0.001). The median central retinal thickness was significantly reduced from 341.0 [281.0, 422.0] to 275.0 [221.0, 344.0] μm (p < 0.001). The median number of visits was 9.0 [8.0, 9.0]. The median number of injections was 7.0 [6.0, 8.0]: 8.0 [7.0, 8.0] for treatment-naïve eyes and 6.0 [5.0, 7.0] for those continuing treatment (p < 0.001). Conclusion: Eyes treated as part of the Polish therapeutic program gained functional stability and morphological improvement. Treatment-naïve eyes showed the greatest functional benefit.

2021 ◽  
Vol 8 (3) ◽  
pp. 167-173
Author(s):  
Małgorzata Wichrowska ◽  
Jarosław Kocięcki ◽  
Wojciech Suda

Introduction: Aflibercept and ranibizumab have become the most used drugs in the treatment of wet age-related macular degeneration. Some patients; however, do not respond to aflibercept and ranibizumab treatment. Our aim was to determine whether the switch from aflibercept to ranibizumab, and then switchback, is effective in a group of patients poorly responding to aflibercept. We assessed best corrected visual acuity, central retinal thickness, and the presence of intra- and subretinal fluid (respectively). Material and methods: We conducted a retrospective comparative case series study. Twenty eyes of 20 patients, who had no inhibition of disease activity after at least one year of treatment with aflibercept, were included in the study. If after switch to ranibizumab the response to the drug was again inadequate, we returned to aflibercept. We divided the study population into two groups: treatment- naïve and patients who had received injections before entering the Drug Program for the Treatment of Age-Related Exudative Macular Degeneration. Results: We observed an improvement in both best corrected visual acuity and central retinal thickness parameters, but only in the treatment-naïve group. We did not observe any statistically credible effects for sub- and intraretinal fluid in the studied groups. Conclusions: Drug conversion may be beneficial for patients poorly responding to primary therapy. Greater improvement is seen in previously untreated patients.


2019 ◽  
Vol 30 (5) ◽  
pp. 1082-1090
Author(s):  
Jordi Monés ◽  
Marc Biarnés ◽  

Importance: To provide new insights into aflibercept effect in non-naive-treated patients with neovascular age-related macular degeneration. Purpose: To assess the efficacy of intravitreal aflibercept in patients with neovascular age-related macular degeneration without optimal response to previous anti-vascular endothelial growth factor A therapy. Design: Single-arm, multi-centre, prospective study. Participants: Patients ⩾50 years with active neovascular age-related macular degeneration, best-corrected visual acuity between 20/32 and 20/320 with suboptimal response to ranibizumab or bevacizumab. Methods: Aflibercept was administered monthly (3-first months), and bimonthly thereafter until month 8. Anatomical and functional outcomes were assessed. Main outcome measure: Percentage of eyes without intra or subretinal fluid on optical coherence tomography after 3-monthly loading doses of aflibercept. Results: A total of 46 patients were included. At week 12, 45.7% (95% confidence interval: 31.5%–60.1%) of eyes showed no fluid on optical coherence tomography. The mean (standard deviation) best-corrected visual acuity increased from 65.1 (8.3) to 69.6 (8.1) letters (+4.5 (5.8) p < 0.0001) and was stabilized at week 40 as compared to baseline. Mean central macular thickness decreased from 430 (119) µm to 323 (100) µm at week 12 (–107 (90) µm, p < 0.0001) and was reduced at week 40 (–46 (111) µm, p = 0.0056). At week 40, 21.7% (95% confidence interval: 9.8%–33.7%) had no fluid. There was a case of presumed noninfectious endophthalmitis that was successfully managed. Conclusion: Almost half of patients presented no fluid on optical coherence tomography at week 12, and there was a clinically significant improvement in best-corrected visual acuity. At week 40, one in five patients did not show intra or subretinal fluid, central macular thickness decreased and best-corrected visual acuity was stabilized compared to baseline.


2019 ◽  
Vol 30 (2) ◽  
pp. 376-381
Author(s):  
Alberto Piatti ◽  
Antonella Croce ◽  
Danilo Mazzacane ◽  
Giovanni Traina ◽  
Lina Ambrosino ◽  
...  

Purpose: To examine the effect of a long-term nutritional supplementation on age-related macular degeneration progression. Methods: In this prospective, double-blind, placebo-controlled study, 80 patients with intermediate age-related macular degeneration were randomized (2:1) to receive 1 tablet/day of a nutritional supplement containing a mixture of carotenoids, vitamins and omega-3 fatty acids or placebo. Age-related macular degeneration progression assessed by digital fundus photography (primary outcome) and best-corrected visual acuity were evaluated. Differences between arms were tested using chi-square test or Fisher’s exact test. Results: Seventy-four patients completed the follow-up at 24 months (48 in the treated arm and 26 in the placebo arm). An age-related macular degeneration progression was observed in the 2.1% of patients of the treated arm and in the 15.4% of patients in the placebo arm (p = 0.05, Fisher’s exact test). Best-corrected visual acuity data alone were not statistically significant among groups. Conclusion: A clinically meaningful stabilization of intermediate age-related macular degeneration over a period of 2 years may be obtained by treating patients with a mixture of carotenoids, vitamins and omega-3 fatty acids.


2015 ◽  
Vol 2015 ◽  
pp. 1-4 ◽  
Author(s):  
Oldřich Chrapek ◽  
Jiří Jarkovský ◽  
Martin Šín ◽  
Jan Studnička ◽  
Petr Kolář ◽  
...  

Aim. To assess the significance of age, gender, baseline best corrected visual acuity, baseline macula thickness, and type and size of choroidal neovascularization in early morphological therapeutic response to ranibizumab treatment in patients with the wet form of age-related macular degeneration.Methods. From 09/2008 to 06/2013 we evaluated 1153 newly diagnosed, treatment-naïve patients treated with ranibizumab. Based on the morphological findings in the macula following the initial 3 injections of ranibizumab, the patients were divided into two groups based on active and inactive choroidal neovascularization.Results. After the initial 3 injections of ranibizumab, we examined the sample of 841 eyes with active CNV and 312 eyes with inactive CNV. In the inactive group, we found a statistically higher proportion of occult CNV (P<0.001) and lower incidence of CNV greater than 5DA (P < 0.001) compared with the active group. We found no statistically significant difference in age, gender, baseline best corrected visual acuity, or baseline macula thickness between the inactive and active groups.Conclusion. Occult CNV and CNV smaller than 5DA are optimistic factors for a better morphological therapeutic response at the beginning of ranibizumab treatment.


2020 ◽  
Author(s):  
Lungwani Muungo

Background: This study aimed to demonstrate the phenotypic and genotypic factors associated with photodynamic therapy (PDT) for age-related macular degeneration (AMD).Methods: The study included 149 patients with exudative AMD treated by PDT. Eight phenotypic factors and ten genotypic factors for three single nucleotide polymorphisms (SNPs; rs800292, rs1061170, rs1410996) in the complement factor H (CFH) gene, rs 11200638-SNP in the high temperature requirement A-1 (HTRA1) gene, two SNPs (rs699947, rs2010963) in the vascular endothelial growth factor (VEGF) gene, and four SNPs (rs12948385, rs12150053, rs9913583, rs1136287) in the pigment epithelium-derived factor (PEDF) gene were evaluated.Results: A significant association with best-corrected visual acuity change was demonstrated in the greatest linear dimension, presence or absence of pigment epithelial detachment, and HTRA1-rs11200638 genotype statistically (P=3.67×10-4, 1.95×10-2, 1.24×10-3, respectively). Best-corrected visual acuity in patients with AA genotype of HTRA1-rs11200638 significantly decreased compared with that in patients with GG genotype (P=1.33×10-3). Logistic regression analyses demonstrated HTRA1-rs11200638 genotype was most strongly associated with best-corrected visual acuity outcome from baseline at 12 months after photodynamic therapy (P=4.60×10-3; odds ratio 2.363; 95% confidence interval 1.303–4.285).Conclusion: The HTRA1-rs11200638 variant showed the most significant association. Therefore, this variant may be used as a prognostic factor to estimate the PDT response with significant predictive power.Keywords: age-related macular degeneration, photodynamic therapy, phenotypic and genotypic factors, high temperature requirement A-1, greatest linear dimension, pigment epithelial detachment


2019 ◽  
pp. 112067211988360
Author(s):  
Tomas Bro ◽  
Staffan Hägg

Purpose: To examine the clinical effects of switching intravitreal drug treatment from the approved vascular endothelial growth factor inhibitors, ranibizumab and aflibercept, to off label use of bevacizumab in patients with wet age-related macular degeneration. Methods: This retrospective study scrutinized medical records of patients with wet age-related macular degeneration who switched therapy to bevacizumab due to a policy decision. Best corrected visual acuity, central retinal thickness, and number of injections before and 1 year after the switch was compared. The non-inferiority margin of best corrected visual acuity was five Early Treatment Diabetic Retinopathy Study letters. Results: A switch from ranibizumab was evaluable in 93 eyes and from aflibercept in 19 eyes. Neither of the groups had a significant non-inferior visual acuity 16 month after the switch. Mean best corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters was 63.8 (95% confidence interval: 61.3–66.4) before and 62.2 (95% confidence interval: 59.3–65.1) after in the ranibizumab group and 68.2 (95% confidence interval: 63.3–73.1) before and 67.7 (95% confidence interval: 62.8–72.6) after in the aflibercept group. Mean central retinal thickness in micrometers decreased from 254 (95% confidence interval: 247–261) to 250 (95% confidence interval: 225–275) in the ranibizumab group and from 265 (95% confidence interval: 255–276) to 262 (95% confidence interval: 251–273) in the aflibercept group. The treatment was changed again after the switch in 18% of the patients in the ranibizumab group and 19% in the aflibercept group and these subjects were excluded from the analyses. Conclusion: In patients with neovascular age-related macular degeneration, a switch from ranibizumab or aflibercept to bevacizumab seems possible without a significant decrease in visual acuity in most patients.


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