Real‐world outcomes of anti‐VEGF therapy in treatment‐naïve neovascular age‐related macular degeneration diagnosed on OCT angiography: the REVEAL study

2021 ◽  
Author(s):  
Marco Lupidi ◽  
Stefano Schiavon ◽  
Alessio Cerquaglia ◽  
Daniela Fruttini ◽  
Ramkailash Gujar ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Oct Angiography ◽  
Anti Vegf ◽  
Age Related ◽  
Reveal Study ◽  
Treatment Naïve

scholarly journals Ten-year survival trends of neovascular age-related macular degeneration at first presentation

2020 ◽  
pp. bjophthalmol-2020-317161
Author(s):  
Cristina Arpa ◽  
Hagar Khalid ◽  
Shruti Chandra ◽  
Siegfried Wagner ◽  
Katrin Fasler ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Visual Outcomes ◽  
Anti Vegf ◽  
Kaplan Meier ◽  
Age Related ◽  
Treatment Naïve ◽  
Mean Trend ◽  
Endothelial Growth Factor ◽  
Good Vision

BackgroundTo describe 10-year trends in visual outcomes, anatomical outcomes and treatment burden of patients receiving antivascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD).MethodsRetrospective cohort study of treatment-naïve, first-affected eyes with nAMD started on ranibizumab before January 1, 2009. The primary outcome was time to best-corrected visual acuity (BCVA) falling ≤35 ETDRS letters after initiating anti-VEGF therapy. Secondary outcomes included time to BCVA reaching ≥70 letters, proportion of eyes with BCVA ≥70 and ≤35 letters in 10 years, mean trend of BCVA and central retinal thickness over 10 years, and mean number of injections.ResultsFor our cohort of 103 patients, Kaplan-Meier analyses demonstrated median time to BCVA reaching ≤35 and ≥70 letters were 37.8 (95% CI 22.2 to 65.1) and 8.3 (95% CI 4.8 to 20.9) months after commencing anti-VEGF therapy, respectively. At the final follow-up, BCVA was ≤35 letters and ≥70 letters in 41.1% and 21%, respectively, in first-affected eyes, while this was the case for 5.4% and 48.2%, respectively, in a patient’s better-seeing eye. Mean injection number was 37.0±24.2 per eye and 53.6±30.1 at patient level (63.1% of patients required injections in both eyes).ConclusionsThe chronicity of nAMD disease and its management highlights the importance of long-term visual prognosis. Our analyses suggest that one in five patients will retain good vision (BCVA ≥70 ETDRS letters) in the first-affected eye at 10 years after starting anti-VEGF treatment; yet, one in two patients will have good vision in their better-seeing eye. Moreover, our data suggest that early treatment of nAMD is associated with better visual outcomes.

scholarly journals Patient satisfaction following a switch from treat-and-extend to observe-and-plan regimen in age-related macular degeneration

2022 ◽  
Vol 7 (1) ◽  
pp. e000930
Author(s):  
Tora Sund Morken ◽  
Christina Knutsen ◽  
Margrete Sætre Hanssen ◽  
Dordi Austeng
Keyword(s):  
Patient Satisfaction ◽  
Macular Degeneration ◽  
Standard Treatment ◽  
Age Related Macular Degeneration ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Anti Vegf ◽  
Age Related ◽  
Treatment Naïve ◽  
Endothelial Growth Factor

ObjectiveStandard treatment of neovascular age-related macular degeneration (nAMD) is intravitreal injections (IVI) of antivascular endothelial growth factor (anti-VEGF) according to treat-and-extend (TnE). Observe-and-plan (OnP), a new regimen based on each individual’s relapse interval lead to fewer clinical visits and has so far shown to be safe in treatment-naïve patients. In this study, we explore patient satisfaction and safety in nAMD when switching from TnE to OnP.Methods and analysis38 participants treated acording to TnE for ≥12 months were included and switched from TnE to OnP with their last stable interval. Main outcome was patient satisfaction (Leeds Satisfaction Questionnaire). Secondary outcomes were best-corrected visual acuity (BCVA), central retinal thickness (CRT) before and 12 months after switch and number of monitoring visits and injections of anti-VEGF 12 months prior to and following switch.ResultsMean patient satisfaction was higher (3.7±0.5 SD) at 12 months after switch from TnE to OnP than before (3.6±0.5 SD, p=0.009, response rate 76%). BCVA and CRT were unchanged. Number of monitoring visits and injections were lower in the 12 months following than prior to switch (p<0.001).ConclusionA switch from TnE to OnP in a non-treatment-naïve population resulted in higher patient satisfaction, while maintaining stable BCVA. This indicates that OnP may be applicable in the large group of nAMD patients that have received IVI for several years. OnP may alleviate the treatment burden on both individual and society of frequent clinical visits while increasing patient satisfaction.

scholarly journals Real-world effectiveness, treatment pattern, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration: Subgroup analyses from the LUMINOUS study

2020 ◽  
Author(s):  
Min Sagong ◽  
Se Joon Woo ◽  
Youkyung Lee
Keyword(s):  
Macular Degeneration ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Loading Dose ◽  
Open Label ◽  
Korean Patients ◽  
Age Related ◽  
Younger Age ◽  
Treatment Naïve ◽  
One Year

Abstract Background To evaluate the real-world effectiveness, treatment patterns, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration (nAMD). Methods LUMINOUS™ is a 5-year, global, prospective, observational, open-label study. Adults aged ≥18 years who were either treatment-naïve or prior-treated were enrolled and treated with ranibizumab 0.5 mg per the local label. Outcome measures included mean (±standard deviation) changes from baseline in visual acuity (VA) and central retinal thickness (CRT), and rate of ocular and non-ocular adverse events (AEs). Results Overall, 367 Korean patients with nAMD (152 treatment-naïve and 215 prior-treated) were enrolled. The mean VA changes from baseline at 1-year were +10.1 (±21.77; P = 0.0005) and +1.4 (±15.17; P = 0.2142) Early Treatment Diabetic Retinopathy Study letters, with mean number of injections of 5.2 and 3.4 in the treatment-naïve and prior-treated groups, respectively. VA gains were greater in patients with worse baseline VA, who received a loading dose, and with polypoidal choroidal vasculopathy (PCV). Multivariate logistic regression analyses demonstrated younger age, worse baseline VA, and those who received loading dose being associated with higher odds of any gain in VA at 1 year ( P < 0.05). Mean CRT changes from baseline were –126.7 (±174.90) µm ( P < 0.0001) and +10.8 (±89.52) µm ( P = 0.5833) in the treatment-naïve and prior-treated groups, respectively, with greater reductions observed in patients with PCV. Ocular and non-ocular AEs were reported in 8.4% (n=31) and 10.1% (n=37) of patients, respectively. Conclusion The LUMINOUS study confirms real-world effectiveness and safety of ranibizumab in Korean patients with nAMD; factors including age, baseline VA, and loading-dose were associated with VA gain at one-year post-treatment.

scholarly journals Treatment patterns in patients with age-related macular degeneration and diabetic macular edema: A real-world claims analysis in Dubai

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254569
Author(s):  
Igor Kozak ◽  
Avinash Gurbaxani ◽  
Ammar Safar ◽  
Prasan Rao ◽  
Amal Masalmeh ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Treatment Patterns ◽  
Age Related Macular Degeneration ◽  
Treatment Frequency ◽  
Anti Vegf ◽  
Age Related

Objectives To characterize the pattern of approved anti-vascular endothelial growth factor (VEGF) treatments among patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in the United Arab Emirates (UAE). Method This was a retrospective, nonrandomized, observational cohort analysis of the Dubai Real-world Claims Database with a 360-day follow-up period. Adult patients diagnosed with nAMD or DME treated with ranibizumab or aflibercept for the first time were included. The primary objective was to evaluate anti-VEGF treatment patterns with respect to the proportion of patients receiving ranibizumab and aflibercept for nAMD and DME separately. Results Of the 451 patients included in the final study cohort, 83.6% and 16.4% had a diagnosis of DME (ranibizumab: 48.5%; aflibercept: 51.5%) and nAMD (ranibizumab: 40.5%; aflibercept: 59.5%), respectively, at baseline. Treatment frequency of ranibizumab/aflibercept was similar for nAMD (mean: 2.4/2.9 injections; p = 0.2389) with fewer injections in the ranibizumab cohort for DME (mean: 1.9/2.5 injections; p = 0.0002). Most patients received ≤3 anti-VEGF injections during the 360-day follow-up period. The time between consecutive treatments was large (nAMD: 73.6 days/10.5 weeks; DME: 80.5 days/11.5 weeks). Approximately 10%–13.5% of patients switched their anti-VEGF therapy. Most patients (83.8%) had a diabetes diagnosis during the follow-up period. Conclusions This real-world study provides an initial understanding of anti-VEGF treatment patterns in patients with nAMD and DME in the UAE. Treatment frequency of the 2 anti-VEGF agents assessed was similar in both patient populations. Both treatments were infrequently administered with large dosing intervals.

Natural History of Treatment-Naïve Quiescent Choroidal Neovascularization in Age-Related Macular Degeneration Using OCT Angiography

2018 ◽  
Vol 2 (9) ◽  
pp. 922-930 ◽  
Author(s):  
Adriano Carnevali ◽  
Riccardo Sacconi ◽  
Lea Querques ◽  
Alessandro Marchese ◽  
Vittorio Capuano ◽  
...  
Keyword(s):  
Natural History ◽  
Macular Degeneration ◽  
Choroidal Neovascularization ◽  
Age Related Macular Degeneration ◽  
Oct Angiography ◽  
Age Related ◽  
Treatment Naïve ◽  
History Of

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

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.

scholarly journals Comparing Effectiveness of Three Different Anti-VEGF Treatment Regimens for Neovascular Age-Related Macular Degeneration: Two Years’ Real-World Clinical Outcomes

2021 ◽  
Vol Volume 15 ◽  
pp. 1703-1713
Author(s):  
Faye Horner ◽  
Peck Lin Lip ◽  
Bashar R Mohammed ◽  
William Fusi-Rubiano ◽  
Eesha Gokhale ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Clinical Outcomes ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Treatment Regimens ◽  
Anti Vegf ◽  
Age Related

Type 3 neovascularisation (retinal angiomatous proliferation) treated with antivascular endothelial growth factor: real-world outcomes at 24 months

2018 ◽  
Vol 103 (9) ◽  
pp. 1337-1341 ◽  
Author(s):  
Alessandro Invernizzi ◽  
Kelvin Teo ◽  
Vuong Nguyen ◽  
Mark Daniell ◽  
David Squirrell ◽  
...  
Keyword(s):  
Growth Factor ◽  
Real World ◽  
Age Related Macular Degeneration ◽  
Anti Vegf ◽  
Age Related ◽  
Antivascular Endothelial Growth Factor ◽  
Treatment Naïve ◽  
Type 3 ◽  
Endothelial Growth Factor

AimsTo compare 24 months outcomes of eyes with retinal angiomatous proliferations (RAPs) treated with antivascular endothelial growth factor (anti-VEGF) with a group of controls diagnosed with other neovascular age-related macular degeneration (nAMD) subtypes in a real-world setting.MethodsTreatment-naïve nAMD eyes that commenced anti-VEGF between January 2006 and November 2015 were identified from a registry of nAMD treatment outcomes. Cases were defined as eyes diagnosed with RAP. Three controls per case were selected among nAMD eyes with non-RAP lesions and matched on baseline visual acuity (VA), year of treatment initiation, anti-VEGF agent first injected and follow-up. Baseline VA was compared with 12 and 24 months VA. Change in VA, number of injections received, proportion of visits with active nAMD and time to first inactivation were compared between RAPs and controls.Results157 RAPs and 469 controls were included. Baseline VA (mean (SD)) increased at 12 months (61.4 (15.5) vs 68.7 (14.7) letters, p<0.001) and remained higher (66.6 (17.3) letters) at 24 months (p<0.001) in RAPs. The change from baseline VA (mean(95% CI)) was significantly higher in RAPs than in controls at 12 months (7.3 (5.4 to 9.1) vs 4.1 (2.8 to 5.4) letters, p=0.01) and at 24 months (5.1 (2.8 to 7.3) vs 2.5 (1 to 4) letters, p=0.056). Both groups received a median of 13 injections. RAPs inactivated earlier and were less active than controls (both p<0.001).ConclusionsRAPs responded well to anti-VEGF, with a significant improvement in VA persisting at 24 months. RAPs had better visual outcomes than controls at 12 and 24 months, tended to inactivate earlier and were less active throughout 2 years follow-up.

scholarly journals Endpoints selection in registration clinical trials and the needs of real-world clinical practice with the example of anti-VEGF therapy in neovascular age-related macular degeneration

2021 ◽  
Vol 14 (1) ◽  
pp. 25-33
Author(s):  
Sergey Yu. Astakhov ◽  
Svyatoslav L. Plavinskii
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Macular Degeneration ◽  
Real World ◽  
New Technologies ◽  
Age Related Macular Degeneration ◽  
Type I ◽  
Regulatory Requirements ◽  
Anti Vegf ◽  
Age Related

The issues of endpoints selection for regulatory requirements and real-world clinical practice using the example of anti-VEGF therapy in neovascular age-related macular degeneration (nAMD) are discussed in the article. New technologies (optical coherent tomography) introduction are shown to change clinical practice but not regulatory requirements on the endpoints. In the same time for regulatory purpose clinical trials design is changed from superiority to non-inferiority. The changes in the approach to primary endpoint selection are not anticipated due to regulators conservatism but there is a requirement to the comparison with best treatment alternative (i.e. same class comparator in case of anti-VEGF therapy) due to ethical reasons. To satisfy real-world clinicians need, the secondary endpoints are analyzed, but multiple testing problem appears. Statistical methods developed in recent years allow using specified comparison to be made without inflating Type I error. HAWK and HARRIER clinical trials demonstrated an example how superiority of brolucizumab over aflibercet on anatomical endpoints was reliably found.

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