scholarly journals Implantation of Scharioth macula lens in patients with age-related macular degeneration: results of a prospective European multicentre clinical trial

2019 ◽  
Vol 4 (1) ◽  
pp. e000322 ◽  
Author(s):  
Sathish Srinivasan ◽  
Gabor Scharioth ◽  
Anneliese Riehl ◽  
Ivan V Tanev ◽  
Pavel Rozsival ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Macular Degeneration ◽  
Intraoperative Complications ◽  
Age Related Macular Degeneration ◽  
Inclusion Criteria ◽  
Multicentre Clinical Trial ◽  
Refractive Outcomes ◽  
Age Related ◽  
The Mean

ObjectiveTo report the visual and refractive outcomes following monocular implantation of a supplementary (piggyback) Scharioth macula lens (SML) in previously pseudophakic eyes with age-related macular degeneration (AMD).Methods and analysisProspective European multicentre clinical trial. 50 eyes of 50 pseudophakic patients with either dry or previously treated and stable neovascular AMD for at least 6 months were included. The inclusion criteria were age over 55, corrected distance visual acuity (CDVA) of 0.4–0.1 (decimal), improvement of at least three lines of corrected near visual acuity (CNVA) when tested with a +6.0 dioptre (D) reading addition at 15 cm, compared with a +2.5 D reading addition at 40 cm using a standardised, self-illuminated Early Treatment Diabetic Retinopathy Study near vision chart. The SML intraocular lens (IOL) was implanted as an add-on/piggyback IOL in the ciliary sulcus, monocularly in the better seeing eye of each subject meeting the inclusion criteria.ResultsThere were no intraoperative complications. One subject had the SML explanted in the postoperative period due to postoperative glare/halos. The mean CNVA improved from 0.23±0.12 (decimal) preoperatively to 0.57±0.33 at 1 year. The mean CDVA remained unchanged measuring 0.19±0.13 preoperatively and 0.19±0.09 at 1 year postoperatively.ConclusionThe SML appears to be safe and effective in improving the CNVA in patients with AMD. Data suggest that the CDVA remains unaffected following implantation. Further data are needed to assess the long-term safety and efficacy.

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.

APEX: a phase II randomised clinical trial evaluating the safety and preliminary efficacy of oral X-82 to treat exudative age-related macular degeneration

2020 ◽  
pp. bjophthalmol-2020-316511
Author(s):  
Michael N. Cohen ◽  
Denis O’Shaughnessy ◽  
Kate Fisher ◽  
Jennifer Cerami ◽  
Carl C Awh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Age Related Macular Degeneration ◽  
Anti Vegf ◽  
Age Related ◽  
Dose Dependent

PurposeThe safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial.MethodsThis phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet. At each 4-week interval visit for 52 weeks, subjects were to be assessed to determine if rescue treatment was needed with anti-VEGF therapy.Results157 patients were enrolled. Due to gastrointestinal and hepatobiliary adverse events and the fulfilment of the primary endpoint, the trial was stopped prematurely after a second interim analysis. The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001). There was a dose-dependent trend in the number of injections over a 52-week period, with the 50 mg (n=40), 100 mg (n=39), 200 mg (n=39) and placebo (n=39) group requiring 6.7, 6.0, 4.7 and 8.1 injections, respectively.ConclusionsX-82 oral therapy in combination with pro re nata anti-VEGF injections showed non-inferiority in visual acuity outcomes while achieving a dose-dependent decrease in the number of anti-VEGF injections compared with placebo. Given the limited tolerability and safety issues observed, X-82 does not have a sufficient benefit to risk profile in treatment of patients with AMD.

scholarly journals High-addition segmented refractive bifocal intraocular lens in inactive age-related macular degeneration: A multicenter pilot study

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0256985
Author(s):  
Gerd U. Auffarth ◽  
Josef Reiter ◽  
Martin Leitritz ◽  
Karl-Ulrich Bartz-Schmidt ◽  
Fabian Höhn ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Intraocular Lens ◽  
Intraoperative Complications ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Near Visual Acuity ◽  
Reading Distance ◽  
Bifocal Intraocular Lens

This multicenter, open-label study aimed to determine the safety and functional outcome of a high-addition segmented refractive bifocal intraocular lens (IOL) in late inactive age-related macular degeneration (AMD). Twenty eyes of 20 patients were enrolled and followed until 12 months after the intervention. Patients underwent cataract surgery with implantation of a LS-313 MF80 segmented refractive bifocal intraocular lens with a near addition of +8.0 D (Teleon Surgical Vertriebs GmbH, Berlin, Germany). The main outcome measures were distance corrected near visual acuity (DCNVA) and safety as determined by intra- and post-operative complications. Secondary outcomes included distance corrected visual acuity (CDVA), uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), the need for magnification to read newspaper, preferred reading distance, speed and performance (logRAD), as well as patient satisfaction. Mean DCNVA improved from 0.95 (±0.19) to 0.74 (±0.35) logMAR, until 6 months after surgery, P<0.05. CDVA improved from 0.70 (±0.23) to 0.59 (±0.30) logMAR, UDVA from 0.94 (±0.25) to 0.69 (±0.34) logMAR, UNVA from 1.08 (±0.19) to 0.87 (±0.43) logMAR. The mean need for magnification decreased from 2.9- to 2.3-fold, preferred reading distance from 23 to 20 cm. No intraoperative complications occurred during any of the surgeries. One patient lost > 2 lines of CDVA between 6 and 12 months, in another case, the study IOL was exchanged for a monofocal one due to dysphotopsia and decreased CDVA. Implantation of a segmented refractive bifocal IOL with +8.0 D addition improves near and distance vision in patients with late AMD and has a satisfactory safety profile.

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.

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.

Consecutive case series of 244 age-related macular degeneration patients undergoing implantation with an extended macular vision IOL

2017 ◽  
Vol 28 (2) ◽  
pp. 198-203 ◽  
Author(s):  
Muhammad A. Qureshi ◽  
Scott J. Robbie ◽  
Fritz H. Hengerer ◽  
Gerd U. Auffarth ◽  
Ina Conrad-Hengerer ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Perioperative Complications ◽  
Case Series ◽  
Age Related Macular Degeneration ◽  
Retinal Eccentricity ◽  
Consecutive Case ◽  
Refractive Outcomes ◽  
Age Related ◽  
Corrected Distance Visual Acuity

Purpose: To determine safety and visual outcomes in eyes with age-related macular degeneration (AMD) implanted with a novel intraocular lens (IOL) that delivers an optimized retinal image to all macular areas within 10 degrees of retinal eccentricity. Methods: This was a consecutive case series of 244 eyes with dry/stable wet AMD and logMAR visual acuity ≥0.3 implanted with iolAMD Eyemax monoTM (London Eye Hospital Pharma), a single-piece, injectable, hydrophobic acrylic IOL sited in the capsular bag. Primary outcome was safety. Secondary outcomes were changes in corrected distance visual acuity (CDVA) and corrected near visual acuity (CNVA) (logMAR). Results: Mean age at surgery was 80 years. Mean duration of follow-up was 3 months (range 1-16 months). No eyes had worsening of CDVA. Frequency of perioperative complications was equivalent to standard IOL implantation. Postoperative refractive outcomes were within ±1 D of the target refraction in 88% of cases. Mean preoperative CDVA improved from 1.06 to 0.71 postoperatively (mean of differences -0.35; 95% confidence interval [CI] -0.3886 to -0.3223; p<0.0001), equating to an approximate Early Treatment Diabetic Retinopathy Study gain of 18 letters. Mean preoperative CNVA (N-point; logMAR conversion) improved from 1.36 to 0.88 postoperatively (mean of differences -0.48; 95% CI -0.53 to -0.44; p<0.0001). Conclusions: This novel IOL appears safe in the short to medium term. Improvements in postoperative CDVA and CNVA exceed those observed with standard implants.

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.

Centenarians With Age-Related Macular Degeneration

2017 ◽  
Vol 1 (5) ◽  
pp. 310-313
Author(s):  
Maxwell S. Stem ◽  
Danny A. Mammo ◽  
Yoshihiro Yonekawa ◽  
Bozho Todorich ◽  
Benjamin J. Thomas ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Clinical Findings ◽  
Age Related Macular Degeneration ◽  
Neovascular Amd ◽  
Ellipsoid Zone ◽  
Age Related ◽  
Snellen Visual Acuity ◽  
The Mean

Purpose: To report the clinical findings in patients ≥100 years old who have age-related macular degeneration (AMD). Methods: We identified patients ≥100 years old who had non-neovascular AMD, neovascular AMD or both. Results: Sixty-two patients were included. The mean (SD) age was 102 (1.4) years (range, 100-106 years). Most patients were white (n = 51, 82%), women (n = 51, 82%), and had at least 1 eye affected by neovascular AMD (n = 55, 89%). The mean Snellen visual acuity (VA) among eyes with neovascular AMD was worse than that for eyes with non-neovascular AMD (20/600 [range, 20/40-hand motions] vs 20/250 [range, 20/20-hand motions], respectively, P = .03). Eyes with an intact subfoveal ellipsoid zone (EZ) had much better mean VA than eyes with an absent or disrupted EZ (20/50 vs 20/500, P = .002). Conclusion: Most centenarians with AMD in our cohort had the neovascular form, and these individuals tended to have poorer vision than those with non-neovascular AMD. The presence of an intact subfoveal EZ is associated with better VA in eyes with neovascular or non-neovascular AMD compared to eyes with an absent or disrupted EZ.

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