Dataset Information

Efficacy of a Modified Treat-and-Extend Aflibercept Regimen for Macular Oedema in Eyes with Central Retinal Vein Occlusion: 2-Year Prospective Study.

ABSTRACT: This prospective, multicentre, interventional study evaluated the efficacy of a modified treat-and-extend (mTAE) aflibercept regimen as personalized therapy for macular oedema (MO) due to central retinal vein occlusion (CRVO). Fifty eyes were studied from 50 patients who were enrolled between November 2016 and July 2019. All patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for 24 months. Primary outcome measures were best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months. Secondary endpoints were BCVA and CST at 24 months. Mean (standard deviation) baseline BCVA (logMAR) and CST were 0.50 (0.51) and 557 (240) µm, respectively. BCVA and CST showed significant improvements at month 12 (0.19 (0.38) and 275 (98) µm, respectively; both p < 0.0001, paired t-test). BCVA and CST also showed significant improvements at 24 months (0.26 (0.50) and 255 (91) µm, respectively, p = 0.0004 and p < 0.0001, paired t-test). The mean numbers of IVA injections and clinic visits over the 24-month study period were 6.2 (3.0) and 10.3 (1.0), respectively. The mTAE regimen of IVA injections for MO due to CRVO was effective in improving BCVA and decreasing CST at 24 months. The mTAE regimen might be an effective personalized therapy for CRVO.

SUBMITTER: Arai Y

PROVIDER: S-EPMC10419814 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Efficacy of a Modified Treat-and-Extend Aflibercept Regimen for Macular Oedema in Eyes with Central Retinal Vein Occlusion: 2-Year Prospective Study.

Arai Yusuke Y Takahashi Hidenori H Inoda Satoru S Sakamoto Shinichi S Tan Xue X Kawashima Hidetoshi H Yanagi Yasuo Y

Journal of clinical medicine 20230802 15

This prospective, multicentre, interventional study evaluated the efficacy of a modified treat-and-extend (mTAE) aflibercept regimen as personalized therapy for macular oedema (MO) due to central retinal vein occlusion (CRVO). Fifty eyes were studied from 50 patients who were enrolled between November 2016 and July 2019. All patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for 24 months. Primary outcome measures were best-corrected visual acuity (BCVA) and central s ...[more]

PMID: 37568491

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Project description:BackgroundTo determine whether aflibercept (Eylea; Regeneron Pharmaceuticals, Inc., Tarrytown, NY) could continue to extend the macular edema free interval in patients on a treat and extend (TAE) with non-ischemic central retinal vein occlusions (CRVOs) previously treated with ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) or bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA) in the second year.MethodsTwenty patients with macular edema secondary to non-ischemic CRVOs previously treated with ranibizumab or bevacizumab were prospectively treated with intravitreal aflibercept injection (IAI) using a TAE dosing regimen. Injection frequencies were extended 2 weeks if there were no signs of disease activity on OCT or change in visual acuity. In the second year of the study, patients who have recurrences of macular edema could be re-challenged with a longer treatment interval under the following criterion: absence of any macular edema on three consecutive visits with the same treatment interval.ResultsTwenty patients had an average duration of a CRVO for 22 months (range 7-90) and averaged an anti-VEGF treatment every 42 days (range 28-60 days). The macular edema free interval increased from 38 to 75 days when switched to aflibercept (p = 0.000003) at month 24. There was an average increase of 37 days (median 34 days; range 0-91 days) in the macular edema free interval with aflibercept. At the month 24 visit, 50% (8/16) went > 12 weeks with a macular edema free interval between IAI. There was an improvement in vision (+ 8 ETDRS letters, p = 0.006) and decreased retinal thickness (158 µm, p = 0.00003) with aflibercept treatment at month 24.ConclusionsThe 2-year results of the NEWTON study demonstrated the sustained benefits of a TAE dosing regimen with aflibercept in patients with chronic CRVOs. The visual acuity gains and anatomic improvements observed at year one were maintained through month 24 with less visits and treatments. This may help minimize the treatment burden in patients with recurrent macular edema secondary to non-ischemic CRVO.Trial Registration ClinicalTrials.gov, NCT01870427, Registered June 6, 2013, https://clinicaltrials.gov/ct2/show/NCT01870427?cond=NEWTON&rank=1.Presented at the RETICON 2017: The Retina Congress with Live Surgery, Chennai, India-April 2017.

Project description:ObjectivesTo review systematically the randomised controlled trial (RCT) evidence for treatment of macular oedema due to central retinal vein occlusion (CRVO).Data sourcesMEDLINE, EMBASE, CDSR, DARE, HTA, NHSEED, CENTRAL and meeting abstracts (January 2005 to March 2013).Study eligibility criteria, participants and interventionsRCTs with at least 12 months of follow-up assessing pharmacological treatments for CRVO were included with no language restrictions.Study appraisal and synthesis methods2 authors screened titles and abstracts and conducted data extracted and Cochrane risk of bias assessment. Meta-analysis was not possible due to lack of comparable studies.Results8 studies (35 articles, 1714 eyes) were included, assessing aflibercept (n=2), triamcinolone (n=2), bevacizumab (n=1), pegaptanib (n=1), dexamethasone (n=1) and ranibizumab (n=1). In general, bevacizumab, ranibizumab, aflibercept and triamcinolone resulted in clinically significant increases in the proportion of participants with an improvement in visual acuity of ≥15 letters, with 40-60% gaining ≥15 letters on active drugs, compared to 12-28% with sham. Results for pegaptanib and dexamethasone were mixed. Steroids were associated with cataract formation and increased intraocular pressure. No overall increase in adverse events was found with bevacizumab, ranibizumab, aflibercept or pegaptanib compared with control. Quality of life was poorly reported. All studies had a low or unclear risk of bias.LimitationsAll studies evaluated a relatively short primary follow-up (1 year or less). Most had an unmasked extension phase. There was no head-to-head evidence. The majority of participants included had non-ischaemic CRVO.Conclusions and implications of key findingsBevacizumab, ranibizumab, aflibercept and triamcinolone appear to be effective in treating macular oedema secondary to CRVO. Long-term data on effectiveness and safety are needed. Head-to-head trials and research to identify 'responders' is needed to help clinicians make the right choices for their patients. Research aimed to improve sight in people with ischaemic CRVO is required.

Dataset Information

Efficacy of a Modified Treat-and-Extend Aflibercept Regimen for Macular Oedema in Eyes with Central Retinal Vein Occlusion: 2-Year Prospective Study.

Publications

Efficacy of a Modified Treat-and-Extend Aflibercept Regimen for Macular Oedema in Eyes with Central Retinal Vein Occlusion: 2-Year Prospective Study.

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