Dataset Information

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes.

ABSTRACT: Purpose:To report the long-term visual and anatomic outcomes of intravitreal injections for macular edema (ME) secondary to retinal vein occlusion (RVO) in a real-life clinical setting. Design:Retrospective interventional case series. Methods:A total of 223 consecutive eyes with ME secondary to RVO, treated with the first three intravitreal Ranibizumab or dexamethasone injections between August 2008 and September 2018, were enrolled in the study. Subsequent retreatment was guided by best-corrected visual acuity (BCVA) and central macular thickness (CMT) measurements, aimed at achieving macular fluid regression and BCVA stability. BCVA and CMT were recorded at baseline and at subsequent annual time points. The mean number of injections administered each year and the incidence of adverse events were recorded. Results:The mean BCVA and CMT at baseline were 0.79 logMar (SD 0.71) and 615.7??m (SD 257.5), respectively. The mean follow-up (FU) period was 47.8 months (min 12-max 120). At 12 months, the mean BCVA and CMT had significantly improved to 0.62 logMar (SD 0.68; p < 0.0001) and 401.04??m (SD 257.5), respectively. The mean follow-up (FU) period was 47.8 months (min 12-max 120). At 12 months, the mean BCVA and CMT had significantly improved to 0.62 logMar (SD 0.68; p < 0.0001) and 401.04?. Conclusion:Intravitreal Ranibizumab and/or dexamethasone injections were found to be effective at inducing a long-lasting improvement of BCVA and CMT in a real-life clinical setting. A safety profile similar to that already well-established in Ranibizumab and dexamethasone treatment was observed, as well as a steady decrease in the number of intraocular injections required. The results support intravitreal treatments for BRVO and CRVO in patient populations with similar characteristics in similar settings.

SUBMITTER: Maggio E

PROVIDER: S-EPMC7040414 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes.

Maggio Emilia E Mete Maurizio M Maraone Giorgia G Attanasio Marcella M Guerriero Massimo M Pertile Grazia G

Journal of ophthalmology 20200213

<h4>Purpose</h4>To report the long-term visual and anatomic outcomes of intravitreal injections for macular edema (ME) secondary to retinal vein occlusion (RVO) in a real-life clinical setting.<h4>Design</h4>Retrospective interventional case series.<h4>Methods</h4>A total of 223 consecutive eyes with ME secondary to RVO, treated with the first three intravitreal Ranibizumab or dexamethasone injections between August 2008 and September 2018, were enrolled in the study. Subsequent retreatment was ...[more]

PMID: 32104597

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Project description:BackgroundThe comparative safety and efficacy of different doses of intravitreal triamcinolone acetonide (IVTA) for diabetic macular edema (DME) and macular edema (ME) secondary to retinal vein occlusion (RVO) is unclear.ObjectivesThis meta-analysis aimed to compare the safety and efficacy of different doses of IVTA in this setting.MethodsA systematic literature search for randomized clinical trials (RCTs) was conducted on Cochrane Library, Ovid MEDLINE, and EMBASE from January 2005 to May 2022. Studies that reported on patients with DME or ME secondary to RVO that received treatment with different doses of IVTA were included. A random-effects meta-analysis was performed. Cochrane's Risk of Bias Tool 2 was used to assess the risk of bias, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines were used to assess certainty of evidence.ResultsFive RCTs reporting on 1,041 eyes at baseline were included in this meta-analysis. In eyes with ME secondary to RVO, high-dose (4 mg) IVTA achieved a significantly better change in best-corrected visual acuity (WMD = -4.75 ETDRS letters, 95% CI = [-7.73, -1.78], p = 0.002) and reduction in retinal thickness (WMD = -93.02 μm, 95% CI = [-153.23, -32.82], p = 0.002) at months 4-6 compared to low-dose (1-2 mg) IVTA. However, high-dose IVTA had a higher risk of intraocular pressure-related adverse events (RR = 2.99, 95% CI = [1.05, 8.50], p = 0.04) and cataract surgery (RR = 5.67, 95% CI = [3.09, 10.41], p < 0.00001) than low-dose IVTA in eyes with ME secondary to RVO. These efficacy and safety differences in high-dose and low-dose IVTA were not observed in DME eyes.ConclusionsThe RCT evidence in this setting is limited. High-dose IVTA achieved greater improvements in visual acuity and reductions in retinal thickness than low-dose IVTA at months 4-6. However, high-dose IVTA had a less favorable safety profile than low-dose IVTA. The significance of these outcomes was based on patients with ME secondary to RVO, but not DME.

Project description:PurposeTo assess the relationship between best-corrected visual acuity (BCVA) and anatomic features in patients with macular edema (ME) related to retinal vein occlusion (RVO).DesignPost hoc analysis of 3 clinical trials, which included verified diagnoses, protocol refractions, and the assessment of OCT and fluorescein angiography (FA) images at a masked reading center.ParticipantsPatients diagnosed with RVO-ME.MethodsCorrelation analyses were performed to determine the correlation between BCVA and macular anatomy at baseline and at 12 and 24 weeks and between changes from baseline to 12 and 24 weeks.Main outcome measuresThe correlations between BCVA and central subfield thickness (CST), ellipsoid zone (EZ) integrity, intraretinal fluid (IRF), subretinal fluid, central leakage, and ischemia were assessed.ResultsIn a total of 828 eyes with RVO-ME, the mean age, BCVA, and CST at baseline was 64.7 years, 51.1 letters, and 656.9 μm, respectively. At baseline, a moderate negative correlation was observed between BCVA and CST (r = - 0.56, P < 0.001). At weeks 12 and 24, the mean BCVA of eyes with definitely abnormal (absent) EZ was statistically significantly worse than that of eyes with normal EZ. At week 12, a moderate negative correlation was observed between changes in BCVA and changes in CST (r = - 0.35, P < 0.001), with a similar degree of association noted at week 24 (r = - 0.35, P < 0.001). At weeks 12 and 24, eyes that showed any improvement in central IRF showed a greater improvement in BCVA than eyes that showed no improvement worsening (week 12: 463 eyes, 18.3 letters vs. 177 eyes, 13.0 letters, respectively, P < 0.001) and (week 24: 332 eyes, 20.2 letters vs. 131 eyes, 13.3 letters, respectively, P < 0.001). With respect to the correlation between baseline BCVA and fluorescein leakage or capillary nonperfusion, the Pearson correlation coefficients were - 0.41 (P < 0.001) and - 0.16 (P = 0.060), respectively.ConclusionsIn addition to CST, there are important clinically relevant relationships between BCVA and both OCT and FA anatomic features in patients with RVO-ME.

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:BackgroundCentral retinal vein occlusion (CRVO) is a common retinal vascular disorder in which macular edema (ME) may develop, with a consequent reduction in visual acuity. The visual prognosis in CRVO-ME is poor in a substantial proportion of patients, especially those with the ischemic subtype, and until recently there has been no treatment of proven benefit. Macular grid laser treatment is ineffective, and whilst a few recent randomized controlled trials (RCTs) suggest short-term gains in visual acuity with intravitreal steroids for patients with non-ischemic CRVO-ME, there is no established treatment for ischemic CRVO-ME. Anti-vascular endothelial growth factor (anti-VEGF) agents have been used to treat ME resulting from a variety of causes and may represent a treatment option for CRVO-ME.ObjectivesTo investigate the effectiveness and safety of intravitreal anti-VEGF agents in the treatment of CRVO-ME.Search strategyWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 8), MEDLINE (January 1950 to August 2010), EMBASE (January 1980 to August 2010), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to August 2010), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1937 to August 2010), OpenSIGLE (January 1950 to August 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov). There were no language or date restrictions in the search for trials. The electronic databases were last searched on 10 August 2010.Selection criteriaWe considered RCTs that compared intravitreal anti-VEGF agents of any dose or duration to sham injection or no treatment. We focused on studies that included individuals of any age or gender with unilateral or bilateral disease and a minimum of six months follow up. Secondarily, we considered non-randomized studies with the same criteria, but did not conduct a separate electronic search for these.Data collection and analysisTwo review authors independently assessed trial quality and extracted data.Main resultsWe found two RCTs that met the inclusion criteria after independent and duplicate review of the search results. These RCTs utilized different anti-VEGF agents which cannot be assumed to be directly comparable. We, therefore, performed no meta-analysis. Evidence from these trials and from other non-randomized case series is summarized in this review.Authors' conclusionsRanibizumab and pegaptanib sodium have shown promise in the short-term treatment of non-ischemic CRVO-ME. However, effectiveness and safety data from larger RCTs with follow up beyond six months are not yet available. There are no RCT data on anti-VEGF agents in ischemic CRVO-ME. The use of anti-VEGF agents to treat this condition therefore remains experimental.

Project description:IntroductionAURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Here, we report the 24-month outcomes in the RVO cohort from France, Germany, Italy, and Taiwan.MethodsAURIGA (NCT03161912) was a prospective observational study. Eligible patients with RVO were enrolled for whom the decision to treat with IVT-AFL had already been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month (M) 12. All statistical analyses were descriptive.ResultsIn 554 treatment-naïve and 65 previously treated patients with RVO, the respective mean (95% confidence interval) change in VA from baseline was + 12.5 (10.8, 14.3) and + 7.9 (3.3, 12.6) letters by M12 and + 11.4 (9.4, 13.3) and + 4.4 (- 0.6, 9.5) letters by M24 (baseline mean ± standard deviation: 51.0 ± 21.9 and 51.9 ± 20.4 letters); 44.0% of treatment-naïve and 27.9% of previously treated patients reported ≥ 15-letter gains by M24. By M24, the mean change in central retinal thickness from baseline was - 247 (- 267, - 227) µm in treatment-naïve patients and - 147 (- 192, - 102) µm in previously treated patients. From baseline to M6, M12, and M24, treatment-naïve patients received a total of 4.0 ± 1.3, 5.5 ± 2.5, and 6.9 ± 4.2 injections, respectively, and previously treated patients received 3.8 ± 1.5, 5.0 ± 2.2, and 6.3 ± 3.7 injections, respectively. The safety profile of IVT-AFL was consistent with that of previous studies.ConclusionsIn AURIGA, patients with RVO experienced clinically relevant functional and anatomic improvements following IVT-AFL treatment in routine clinical practice. These improvements were largely maintained in treatment-naïve patients over the 24-month study despite the decreasing treatment frequency, suggesting long-term durability of IVT-AFL treatment outcomes. Infographic available for this article.Trial registrationClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017). INFOGRAPHIC.

Dataset Information

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes.

Publications

Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes.

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