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Combination therapy of intravitreal bevacizumab with single simultaneous posterior subtenon triamcinolone acetonide for macular edema due to branch retinal vein occlusion.

ABSTRACT: PurposeTo evaluate efficacy and safety of combination therapy of intravitreal bevacizumab (IVB) with single simultaneous posterior subtenon triamcinolone acetonide (STA) for treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO).MethodsThis was a prospective, randomized, interventional comparative study conducted in 45 eyes with ME secondary to BRVO who were treated primarily with IVB 1.25?mg (23 eyes, IVB group) or combination therapy of IVB 1.25?mg with a single simultaneous STA 40?mg (18 eyes, IVB/STA group). Reinjections were performed with IVB if optical coherence tomography (OCT) showed recurrent ME associated with decreased visual acuity. The main outcome measurement was the number of additional IVB injections, and changes of best-corrected visual acuity (BCVA) and central macular thickness (CMT) during a 6-month follow-up period were compared.ResultsBCVA showed significant improvement in two groups at 6 months. In addition, CMT showed significant decrease in two groups at 6 months. No significant differences in the change of BCVA and CMT at 6 months after injection (P=0.973, P=0.639) were observed between the two groups. A statistically significant difference was found regarding the number of additional IVB injections (IVB group 0.96±0.83; IVB/STA group 0.44±0.70, P=0.034).ConclusionAlthough combination therapy of IVB with a single simultaneous STA for treatment of ME secondary to BRVO did not affect the visual outcomes compared with IVB monotherapy, it had a benefit of reducing the number of additional IVB injections.

SUBMITTER: Moon J

PROVIDER: S-EPMC4985687 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Combination therapy of intravitreal bevacizumab with single simultaneous posterior subtenon triamcinolone acetonide for macular edema due to branch retinal vein occlusion.

Moon J J Kim M M Sagong M M

Eye (London, England) 20160527 8

PurposeTo evaluate efficacy and safety of combination therapy of intravitreal bevacizumab (IVB) with single simultaneous posterior subtenon triamcinolone acetonide (STA) for treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO).MethodsThis was a prospective, randomized, interventional comparative study conducted in 45 eyes with ME secondary to BRVO who were treated primarily with IVB 1.25 mg (23 eyes, IVB group) or combination therapy of IVB 1.25 mg with a single simu ...[more]

PMID: 27229707

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Project description:ImportanceThe Standard of Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study showed that intravitreal triamcinolone acetonide (IVTA) is effective at reducing macular edema and improving visual acuity in participants with retinal vein occlusion. Secondary analysis of the incidence, risk factors, and timing of intraocular pressure (IOP) elevation occurring after IVTA provides guidance for clinical decision making and management of patients treated with IVTA.ObjectiveTo investigate the incidence, risk factors, and time course of IOP elevation in participants in the SCORE Study.Design, setting, and participantsSecondary analysis conducted from August through December 2014 of a prospective, randomized clinical trial featuring an evaluable population conducted at 75 clinical sites. Six hundred eighty-two patients with macular edema secondary to retinal vein occlusion were enrolled in the study. The SCORE Study enrollment period ran from November 4, 2004, to February 29, 2008, with participant follow-up ending February 28, 2009.InterventionsStudy participants were randomized to standard of care, 1 mg of IVTA, or 4 mg of IVTA therapy and followed up for a mean (SD) of 24.7 (10.3) months.Main outcomes and measuresIntraocular pressure elevation greater than 10 mm Hg from baseline.ResultsKaplan-Meier incidences of IOP elevation greater than 10 mm Hg from baseline at 36 months were 0.02 (95% CI, 0.01-0.06), 0.09 (95% CI, 0.05-0.14), and 0.45 (95% CI, 0.38-0.53) in the standard of care, 1-mg IVTA, and 4-mg IVTA groups, respectively. The rates of IOP-related events were higher for the 4-mg IVTA group compared with the other groups (P ≤ .001 for main outcome measure). Younger age, 4-mg IVTA vs 1-mg IVTA treatment, and higher baseline IOP were found to confer greater risk for IOP-related events (P < .05 for all). The median number of days from time of first injection to IOP elevation greater than 10 mm Hg from baseline was 34.0 and 52.5 days in participants treated with 1-mg and 4-mg IVTA, respectively.Conclusions and relevanceIntravitreal triamcinolone acetonide injection therapy, in particular the 4-mg dose, is associated with an increased risk for IOP elevation. The risk factors for an IOP-related event include higher treatment dose, younger age, and higher baseline IOP. Intraocular pressure-related events may take several months from the time of first IVTA injection to occur. Clinicians should be mindful of these risk factors when assessing the risks and benefits of IVTA therapy and also of the need for long-term follow-up of participants at risk for this complication.Trial registrationclinicaltrials.gov Identifier: NCT00105027.

Project description:ObjectiveTo evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).DesignMulticenter, randomized clinical trial.ParticipantsEight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320.MethodsEyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years.Main outcome measuresVisual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety.ResultsAt 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively.ConclusionsOver a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.

Project description:BACKGROUND:Intravitreal agents have replaced observation in macular edema in central (CRVO) and grid laser photocoagulation in branch retinal vein occlusion (BRVO). We conducted a systematic review to evaluate efficacy and safety outcomes of intravitreal therapies for macular edema in CRVO and BRVO. METHODS AND FINDINGS:MEDLINE, Embase, and the Cochrane Library were systematically searched for RCTs with no limitations of language and year of publication. 11 RCTs investigating anti-VEGF agents (ranibizumab, bevacizumab, aflibercept) and steroids (triamcinolone, dexamethasone implant) with a minimum follow-up of 1 year were evaluated. EFFICACY CRVO:Greatest gain in visual acuity after 12 months was observed both under aflibercept 2 mg: +16.2 letters (8.5 injections), and under bevacizumab 1.25 mg: +16.1 letters (8 injections). Ranibizumab 0.5 mg improved vision by +13.9 letters (8.8 injections). Triamcinolone 1 mg and 4 mg stabilized visual acuity at a lower injection frequency (-1.2 letters, 2 injections). BRVO:Ranibizumab 0.5 mg resulted in a visual acuity gain of +18.3 letters (8.4 injections). The effect of dexamethasone implant was transient after 1.9 implants in both indications. SAFETY:Serious ocular adverse events were rare, e.g., endophthalmitis occurred in 0.0-0.9%. Major differences were found in an indirect comparison between steroids and anti-VEGF agents for cataract progression (19.8-35.0% vs. 0.9-7.0%) and in required treatment of increased intraocular pressure (7.0-41.0% vs. none). No major differences were identified in systemic adverse events. CONCLUSIONS:Anti-VEGF agents result in a promising gain of visual acuity, but require a high injection frequency. Dexamethasone implant might be an alternative, but comparison is impaired as the effect is temporary and it has not yet been tested in PRN regimen. The ocular risk profile seems to be favorable for anti-VEGF agents in comparison to steroids. Because comparative data from head-to-head trials are missing currently, clinicians and patients should carefully weigh the benefit-harm ratio.

Project description:BackgroundTo study potential ischemic effects of intravitreal Bevacizumab (IVB) on unaffected retina in treatment-naive eyes with macular edema secondary to branch retinal vein occlusion (BRVO) and contralateral eyes secondary to systemic absorption.Methods and findingsProspective, interventional series included 27 treatment-naive eyes with BRVO and macular edema.Exclusion criteriaEyes with diabetic retinopathy, glaucoma, vasculitides, papilledema or systemic neurologic condition. Subjects underwent complete ophthalmological examination including fluoroscein angiography (FA), optical coherence tomography (OCT) and multifocal electroretinogram (mf-ERG). All subjects received single 1.25 mg/0.05ml IVB injection. Two observers measured all parameters; inter-observer agreements were expressed as kappa values. Paired t-test was used to compare values at baseline and follow-up. The statistical analysis was done using SPSS for Windows, Version 14.0. (Chicago, SPSS Inc.) Presenting mean CFT (central foveal thickness) was 499.5(+/-229.7) μm, mean BCVA (best corrected visual acuity) was 0.64(+/-0.41) logMAR. At last follow-up, mean CFT was 267.9(+/-159.3) μm (P<0.001), 95% CI [127.18, 422.32]; mean BCVA was 0.28(+/-0.24) logMAR. Respectively, mean N1 and P1 amplitudes of mfERG in 'unaffected quadrant' at presentation were -6.10(+/-4.00) nV/deg2 and 17.17(+/-11.54)nV/deg2; and -5.33(+/-1.30)nV/deg2 and 15.29(+/-4.69)nV/deg2 at final follow-up (P = 0.631 and 0.197, respectively), (95% CIs [-0.93, 1.42] and [-4.22, 1.08] respectively). In fundus quadrant of fellow eyes corresponding to unaffected quadrant in treated eyes, mean N1 and P1 amplitudes at presentation were -5.39(+/-1.56)nV/deg2 and 15.89(+/-3.89)nV/deg2; and -5.39(+/-1.90)nV/deg2 and 15.9(+/-5.52)nV/deg2 (P = 0.380 and 0.208), (95% CIs [-0.57, 1.28] and [-4.1, 1.1]) at last follow-up, respectively.LimitationsThis study analysed the effects with a single injection of bevacizumab. However, whether ischemic adverse effects will emerge with repeated IVB injections as a consequence of cumulative dosing needs further investigation. The setting of our study being a tertiary care centre, the numbers of fresh BRVO cases without prior intervention were limited. Thus, the limitations of our study include a small sample size with a small follow-up period. No major ocular/systemic adverse event was observed in the study period.ConclusionNo evidence of progressive ischaemia attributable to single bevacizumab treatment was observed in this study. However, a larger prospective study involving subjects with cumulative dosing of bevacizumab and a longer follow-up could provide a better understanding of the potential ischaemic effects of bevacizumab or other anti-VEGF agents.

Dataset Information

Combination therapy of intravitreal bevacizumab with single simultaneous posterior subtenon triamcinolone acetonide for macular edema due to branch retinal vein occlusion.

Publications

Combination therapy of intravitreal bevacizumab with single simultaneous posterior subtenon triamcinolone acetonide for macular edema due to branch retinal vein occlusion.

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