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Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review.

ABSTRACT: OBJECTIVE:To compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO). DESIGN:Systematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE). DATA SOURCES:PubMed, Cochrane Library and ClinicalTrials.gov registry were searched from inception to 10 December 2019, without language restrictions. ELIGIBILITY CRITERIA:Randomised controlled trials (RCTs) and real-world observation studies comparing the efficacy of DEX implant and anti-VEGF agents for the treatment of patients with RVO, naïve or almost naïve to both arms, were included. DATA EXTRACTION AND SYNTHESIS:Two reviewers independently extracted data for mean changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) and product safety. Review Manager V.5.3 and GRADE were used to synthesise the data and validate the evidence, respectively. RESULTS:Four RCTs and 12 real-world studies were included. An average lower letter gain in BCVA was determined for the DEX implant (mean difference (MD) = -6.59; 95%?CI -8.87 to -4.22 letters) administered at a retreatment interval of 5-6?months. Results were similar (MD6 months=-12.68; 95%?CI -21.98 to -3.37 letters; MD12 months=-9.69; 95%?CI -12.01 to -7.37 letters) at 6 and 12 months. The DEX implant resulted in comparable or marginally less CST reduction at months 6 and 12 but introduced relatively higher risks of elevated intraocular pressure (RR=3.89; 95%?CI 2.16 to 7.03) and cataract induction (RR=5.22; 95%?CI 1.67 to 16.29). Most real-life studies reported an insignificant numerical gain in letters for anti-VEGF drugs relative to that for DEX implant. However, the latter achieved comparable efficacy with a 4-month dosage interval. CONCLUSION:Compared with anti-VEGF agents, DEX implant required fewer injections but had inferior functional efficacy and safety. Real-life trials supplemented the efficacy data for DEX implant.

SUBMITTER: Ming S

PROVIDER: S-EPMC7322510 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review.

Ming Shuai S Xie Kunpeng K Yang Mingzhu M He Huijuan H Li Ya Y Lei Bo B

BMJ open 20200628 6

<h4>Objective</h4>To compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO).<h4>Design</h4>Systematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).<h4>Data sources</h4>PubMed, Cochrane Library and <i>ClinicalTrials.gov</i> registry were searched from inception to 10 December ...[more]

PMID: 32595145

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Project description:Purpose:To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion. Methods:Twenty-six consecutive patients affected by retinal vein occlusion complicated by cystoid macular edema were enrolled in this prospective interventional study. All patients underwent a baseline complete ophthalmological evaluation as well as retinal angiography, OCT examination, and microperimetry evaluation. Each patient was treated with intravitreal injection of a long-term steroid implant (Ozurdex, Allergan). Follow-up evaluations were performed at months 1, 3, and 6 and completed by OCT and MP1 examination. Clinical data underwent statistical analysis. Results:Baseline functional evaluation showed mean visual acuity of 0,63±0,42 LogMAR and retinal sensitivity of 7,93±4,73?dB (mean±standard deviation); after treatment, at day 30 we found, respectively, 0,43±0,38 LogMAR (p<0.05, compared to baseline) and 10,15±4,410?dB (p<0.05); at day 90, we found 0,44±0,32 (p<0.05) and 9.61±4,29?dB (p<0.05); at day 180, we found 0,41±0,31 (p<0.05) and 9,95±3,79?dB (p<0.05). Fixation pattern improved significantly (p<0.05), showing a stable fixation in 30% of patients at baseline, increasing to 77% of patients at day 180. Baseline morphological evaluation showed a central retinal thickness (CRT) of 398,21±181,65??m after treatment; we found a CRT of 222,64±95,21??m at day 30 (p<0.05, compared to baseline), 307,50±120,25??m (p<0.05) at day 90, and 294,93±135,86??m (p<0.05) at day 180. About 15,3% patients showed already at month 3 a recurrence of macular edema. They underwent a retreatment before month 6 as for treatment guidelines. Conclusion:Our detailed analysis showed the significative increase in retinal function in the early phases of the follow-up. Retinal sensibility showed a stronger correlation than VA in macular edema reabsorption, better underlying the progressive functional recovery and increase in quality of vision and life for the patients. This trial is registered with ClinicalTrials.gov NCT03559491.

Project description:PURPOSE:To test the efficacy of the intravitreal dexamethasone (DEX) implant in patients with retinal vein occlusions (RVOs) who have failed multiple anti-vascular endothelial growth factor (anti-VEGF) treatments. METHODS:A randomized exploratory study of ten patients with branch RVO or central RVO who received at least two previous anti-VEGF treatments and had persistent or unresponsive cystoid macular edema. Treatment with the DEX implant was either every 4 months or pro re nata (PRN) depending on their group assignment for 1 year. Multifocal electroretinography and microperimetry were the primary end points, with high-resolution optical coherence tomography and best-corrected visual acuity as the secondary end points. RESULTS:All patients in both the every 4 month and PRN cohorts who completed the study received the three maximal injections of DEX; therefore, the data from both cohorts were combined and reported as a case series. On average, the multifocal electroretinography amplitude increased significantly from 5.11±0.66 to 24.19±5.30 nV/deg2 at 12 months (P<0.005), mean macular sensitivity increased from 7.67±2.10 to 8.01±1.98 dB at 4 months (P=0.32), best-corrected visual acuity increased significantly from 51.0±5.1 to 55.4±5.1 early treatment of diabetic retinopathy study letters at 2 months (P<0.05), and central retinal thickness decreased from 427.6±39.5 to 367.1±37.8 ?m at 4 months (P<0.05). Intraocular pressure increased significantly in one patient, with that patient requiring an additional glaucoma medication for management. Additionally, cataract progression increased significantly (P<0.05) in this patient population and partially limited analysis of other end points. CONCLUSION:DEX should be considered as a treatment option in patients with RVOs who have failed anti-VEGF therapy, as the results of this study demonstrated an improvement in retinal morphology and macular function. Cataract progression did occur following multiple consecutive injections; however, steroid-induced glaucoma was not a limiting factor.

Dataset Information

Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review.

Publications

Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review.

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