scholarly journals Fixed Regimen Treatment in Unselected Naïve Patients Cohort with Neovascular Age-Related Macular Degeneration

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Ricardo P. Casaroli-Marano ◽  
Carolina Bernal-Morales ◽  
Lillian Chamorro-López ◽  
Marina Dotti-Boada ◽  
Juan P. Figueroa-Vercellino ◽  
...  

The current treatment of neovascular age-related macular degeneration (nAMD) generates an excessive care pressure in the public health system. The search for a satisfactory treatment regimen, whose anatomical and functional stability may be achieved, is a challenge and a goal to be reached. We analyzed the outcomes in a patient cohort under fixed regimen treatment with intravitreal aflibercept (IVA). A retrospective study, with at least 1-year follow-up, in consecutive treated unselected naïve patients was carried out. Standard protocol was performed and evaluated at baseline, month 4 (after loading dose, LD), and month 12 (after fixed bimonthly regimen). One hundred six patients (123 eyes) aged 80.3 ± 7.7 years were included, receiving 6.8 ± 0.7 IVA. Visual acuity gain after LD was 5.5 ± 12.0 letters ( p < 0.0001 ). At month 12, 23 eyes (18.7%) gained ≥15 letters and 58 (47.1%) had best-corrected visual acuity ≥20/40 (70 letters). The improvement in visual acuity was lower in patients with polypoidal choroidal vasculopathy (+4.9 ± 18.1 letters; p = 0.2544) and somewhat higher in patients with retinal angiomatous proliferation (+5.4 ± 12.3 letters; p = 0.0373 ). Dry macula was present in only 9.8% of cohort at baseline vs. 69.7% at month 12 ( p < 0.0001 ). Atrophy was the most observed complication and related to the elderly patients. The average of follow-up visits was 3 ± 0.5. Functional and anatomical improvement were observed with IVA in a fixed bimonthly regimen treatment after LD, with results maintained up to one year with a good compliance. The fixed bimonthly regimen optimized patient management and logistic issues.

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Fenghua Wang ◽  
Yuanzhi Yuan ◽  
Ling Wang ◽  
Xiaofeng Ye ◽  
Jingke Zhao ◽  
...  

Purpose. To compare the functional and anatomical outcomes of one dose and three loading doses followed by the pro re nata (PRN) regimen in Chinese neovascular age-related macular degeneration (nvAMD) (including polypoidal choroidal vasculopathy (PCV)) patients. Methods. In this multicenter, prospective, open-label, controlled, 12-month study (ClinicalTrials.gov: NCT02810808), patients were randomized (1 : 1) to 1 dose + PRN (PRN group) or 3 loading doses + PRN (LD group) using intravitreal ranibizumab treatment. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated. The main outcome was the change in BCVA. The noninferiority limit was 5 letters. Results. Forty-five patients in the PRN group and 49 patients in the LD group finished 12-month follow-up. Each group included 4 PCV patients. The mean change in BCVA from baseline was 7.8 letters in the PRN group, compared with 10.9 letters in the LD group (P=0.344). There were no significant differences between two groups in the mean change of CRT (−159.3 μm vs. −120.5 μm) at month 12. The mean number of injections during the 12-month follow-up was 6.0 in the PRN group and 6.8 in the LD group. The proportion of patients who gained an improvement in visual acuity by 15 or more letters was 28.9% in the PRN group and 44.9% in the LD group (P=0.066). Conclusion. One dose + PRN showed noninferior visual gains than 3 loading doses + PRN regimen using ranibizumab in Chinese nvAMD and PCV patients. Number of injections in the PRN group was similar as that in the LD group but remained a potential risk of vision instability during one-year follow-up using OCT-guided retreatment criteria. This trial is registered with NCT02810808.


2015 ◽  
Vol 233 (3-4) ◽  
pp. 155-161 ◽  
Author(s):  
João Pinheiro-Costa ◽  
José M. Costa ◽  
João N. Beato ◽  
Paulo Freitas-da-Costa ◽  
Elisete Brandão ◽  
...  

Purpose: To report the clinical outcomes of intravitreal aflibercept therapy in eyes with refractory and recurrent neovascular age-related macular degeneration (AMD) switched from intravitreal bevacizumab or ranibizumab. Methods: This is a retrospective review of eyes with neovascular AMD switched to intravitreal aflibercept with at least 1 year of follow-up after the switch. All patients had had a minimum of 3 injections of bevacizumab or ranibizumab before the switch. Aflibercept was used in patients considered refractory to bevacizumab (group 1) and in recurrent patients on therapy with ranibizumab due to an institutional policy decision (group 2). Changes in best-corrected visual acuity, fluid on optical coherence tomography (OCT), central retinal thickness (CRT) and the frequency of injections were compared. Results: Eighty-five eyes of 69 patients were analyzed, 39 eyes in group 1 and 46 in group 2. The mean follow-up time was 31.6 months prior to the switch and 14.7 months on treatment with aflibercept. One year after the switch, there was a nonsignificant mean decrease of 2 letters in visual acuity in both groups (group 1: from 58.2 to 55.8 letters, p = 0.086; group 2: from 56.4 to 54.5 letters, p = 0.168), but the mean number of injections per month was significantly lower (from 0.76 to 0.57, p < 0.001). With the switch, 90.6% of the patients showed anatomic improvement with a reduction of fluid on OCT, and both groups presented significant improvement in CRT (group 1: 65.3 µm, p = 0.051; group 2: 91.0 µm, p < 0.001). Conclusion: Aflibercept appears to be a valuable tool for the management of patients with poor responses to other anti-vascular endothelial growth factor drugs. These patients could have anatomic improvement, and the injection intervals could be extended.


2014 ◽  
Vol 7 (4) ◽  
pp. 13-21
Author(s):  
Yuriy Sergeyevich Astakhov ◽  
Gassan Basharovich Shaar ◽  
Nikita Yur’yevich Dal’

Purpose. To study the effects of vitrectomy on the course of wet age-related macular degeneration (AMD). Materials and methods. 99 patients (99 eyes) with wet AMD associated with vitreo-macular adhesion or posterior hyaloid traction were included in the study. During the first 6 months, all patients received anti-VEGF treatment according to a PRN regimen. Then, they were divided into two groups: in 45 patients vitrectomy was performed and 54 patients did not receive surgical treatment. The follow-up period duration was one year. Results. At the beginning of the study, visual acuity was 0.27 ± 0.17 in the control group, and 0.17 ± 0.15 in the treatment group. Most prominent differences in visual acuity between the two groups were observed during the first 6 months (visual acuity in the treatment group before surgery was 0.12 ± 0.1) (p < 0.01 and p < 0.001), at the same time during the following 6 follow-up months, this difference decreased (p < 0.05 and p < 0.01). 1 year from the study start, visual acuity in the control group was 0.24 ± 0.17, and 0.17 ± 0.13 in the treatment one. Conclusions. Vitrectomy surgery in patients with wet AMD in association with vitreo-macular adhesion or posterior hyaloid traction does not exacerbate the disease course, stabilizes visual functions and improves the quality of life.


2016 ◽  
Vol 236 (2) ◽  
pp. 95-99 ◽  
Author(s):  
Sebastian Wolf ◽  
Francesco Bandello ◽  
Anat Loewenstein ◽  
Jason Slakter ◽  
Todd Katz ◽  
...  

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.


1999 ◽  
Vol 1 (1) ◽  
pp. 3-9
Author(s):  
John Newnham

This paper aims to provide an overview of age related macular degeneration (ARMD) and its radiotherapy management.ARMD is already the leading cause of adult blindness in the western world. The neovascular form of ARMD is responsible for some 85% of blindness caused by ARMD as a whole. Its aetiology is unknown. The natural course of the disease is rapid progression from onset to disciform scarring and accompanying loss of visual acuity. Laser photocoagulation is only suitable for 10% of patients with neovascular ARMD. Initial studies using low dose fractionated external beam radiotherapy have demonstrated stable visual acuity over the range of 40–93% at short term follow-up. Only transient acute side effects have been observed. No radiation-induced retinopathy or vasculopathy have been observed. Common radiotherapy macula techniques are reviewed, field sizes examined and criteria for a simple macula technique proposed. A subset of patients with rapidly progressing neovascular ARMD may be candidates for rapid treatment starts. Although follow up times have been short, radiotherapy is a promising option for those patients facing imminent blindness due to rapidly progressive neovascular ARMD.


2001 ◽  
Vol 11 (3) ◽  
pp. 309-312 ◽  
Author(s):  
B. Sadowski ◽  
C. Kriegbaum ◽  
E. Apfelstedt-Sylla

Purpose Differential diagnosis of maculopathies can be difficult but is important if patients also suffer from other diseases such as breast cancer treated with antiestrogens. The main possible diagnoses, especially in the elderly, are age-related macular degeneration, tamoxifen and cancer-associated retinopathy (CAR). Methods We describe an 84-year-old patient with breast and colon cancer, who complained of a decrease in visual acuity after treatment with low-dose antiestrogens. She underwent a general ophthalmological investigation, perimetry and electroretinographic examination with multifocal (m-ERG) and flash-electroretinogram (flash-ERG). Results Visual acuity was reduced to 1/50 and 0.3. The ophthalmological examination was normal, except for extensive bilateral maculopathy with shining crystalline deposits, central and peripheral visual field defects, slightly affected scotopic and photopic potentials in the flash-ERG, and an abnormal m-ERG. Conclusions The findings are expected with age-related macular degeneration with crystalline drusen, but also with CAR. Even if the single and total dosage of antiestrogens given to the patient is sufficient to cause tamoxifen retinopathy, this diagnosis can be excluded because, in tamoxifen retinopathy unlike in the case presented here, the deposits are not distributed in all retinal layers.


2021 ◽  
Vol 62 (9) ◽  
pp. 1218-1226
Author(s):  
Gon Soo Choe ◽  
Jong Woo Kim ◽  
Chul Gu Kim ◽  
Jae Hui Kim

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.


2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  

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.


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