Intravitreal steroids versus observation for macular edema secondary to central retinal vein occlusion.
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SUBMITTER: Gewaily D
PROVIDER: S-EPMC4733851 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AIM:To report the efficacy of intravitreal ziv-aflibercept injections in eyes with macular edema due to retinal vein occlusions (RVOs). METHODS:Consecutive patients with persistent or recurrent macular edema (central macula thickness >250 ?m) due to RVO were enrolled in this prospective study. Study eyes received intravitreal injections of ziv-aflibercept (1.25 mg/0.05 mL) at baseline. Patients were reassessed monthly for 4 months and given additional injections pro re nata for worsening best-corrected visual acuity (BCVA), intraretinal edema or subretinal fluid seen on spectral domain optical coherence tomography, or central macular thickness (CMT) measurements >250 ?m. The primary endpoint was improvement in mean CMT at 4 months. Secondary endpoints included improvement in mean BCVA, and ocular and systemic safety signals. RESULTS:Nine eyes (five central and four branch RVOs) of nine patients were enrolled. The mean ± standard deviation CMT decreased from 604±199 ?m at baseline to 319±115 ?m (P=0.001) at 1 month and to 351±205 ?m (P=0.026) at 4 months. The mean BCVA did not improve significantly from baseline (1.00 LogMAR) to the 1-month (0.74 LogMAR; P=0.2) and 4-month (0.71 LogMAR; P=0.13) visits. No safety signals were noted. CONCLUSION:In this small prospective study, intravitreal ziv-aflibercept significantly improved mean CMT in eyes with persistent or recurrent macular edema due to RVOs. Prospective, randomized trials comparing ziv-aflibercept with standard pharmacotherapy are needed to better define efficacy and safety.
| S-EPMC5038569 | biostudies-literature
Project description:To assess the efficacy and safety of intravitreal conbercept injections in patients with macular edema secondary to retinal vein occlusion (RVO).A prospective, Phase II clinical trial was performed on 60 patients with macular edema secondary to RVO. Thirty patients had branch RVO (BRVO) and 30 had central RVO (CRVO). Each patient received intravitreal injections of conbercept monthly up to 3 months, followed by monthly evaluation and injection pro re nata to Month 9.The average change of best-corrected visual acuity from baseline to Month 9 was 17.83 ± 10.89 letters in BRVO and 14.23 ± 11.74 letters in CRVO. The change in best-corrected visual acuity was not statistically different between the groups (P = 0.216). The mean reduction of central retina thickness from baseline to Month 9 was 289.97 ± 165.42 ?m and 420.47 ± 235.89 ?m in BRVO and CRVO, respectively. The mean numbers of injections was 7.14 ± 1.90 in BRVO and 7.59 ± 1.39 in CRVO from baseline to Month 9 (P = 0.4705). There were 7 serious adverse events (SAEs) in 5 patients (8.33%, 2 BRVO and 3 CRVO). All the SAEs were nonocular and were not related to the drug or the injection procedure.Intravitreal injections of conbercept demonstrated a generally favorable safety and tolerability profile as well as efficacy in the treatment of macular edema due to RVO.
| S-EPMC5598918 | biostudies-literature
Project description: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.
| S-EPMC7040414 | biostudies-literature
Project description:BACKGROUND:Central 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. OBJECTIVES:To investigate the effectiveness and safety of intravitreal anti-VEGF agents in the treatment of CRVO-ME. SEARCH STRATEGY:We 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 CRITERIA:We 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 ANALYSIS:Two review authors independently assessed trial quality and extracted data. MAIN RESULTS:We 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' CONCLUSIONS:Ranibizumab 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.
| S-EPMC4302326 | biostudies-literature
Project description:Background. Ranibizumab is approved for treatment of macular edema in eyes with retinal vein occlusion (RVO). Some eyes show low-response to treatment with regard to visual acuity gain (VA) and OCT central retinal thickness (CRT) reduction. The goal of this study was to quantify the percentage of low-responders. Methods. Treatment of naïve eyes with macular edema secondary to RVO was included and monthly VA and CRT were analyzed. Four weeks after the loading phase, and at the end of the study, eyes were grouped into low- and good responders based on predefined criteria. The responder and low-responder groups were then compared at various time points. Results. Forty-three eyes were included. Regarding VA, 27.9% were low-responders after the loading phase and 30.2% at the end of the study. For CRT, 34.9% were low-responders after the loading phase versus 27.9% at the end of the study. 75% of patients that were VA low-responders and 73.3% of CRT low-responders after loading phase remained low-responders at the end of the study. Conclusion. Approximately 30% of patients showed low response to ranibizumab after the loading phase and after 1 year of treatment. Two-thirds of patients that were low-responders after the loading phase remained low-responders after 1 year.
| S-EPMC5156818 | biostudies-literature
Project description:PurposeTo evaluate whether treatment with intravitreal corticosteroid and anti-vascular endothelial growth factor (VEGF) injections alternately can improve treatment outcomes of macular edema (ME) caused by retinal vein occlusion (RVO).MethodsThis dual-center retrospective study included 112 eyes with treatment-naïve ME secondary to RVO that were alternately treated with intravitreal corticosteroid and anti-VEGF injections (33 eyes, alternate group) or treated only with intravitreal anti-VEGF injections (79 eyes, anti-VEGF group) on a pro re nata basis.ResultsDuring the 12-month follow-up period, the alternate group achieved a visual acuity gain of 0.39 logMAR, while the anti-VEGF group achieved a gain of 0.21 logMAR (P=0.042). The alternate group demonstrated a reduction in the central macular thickness of 229.9-μm, while the anti-VEGF group achieved a reduction of 220.1 μm (P=0.887). The alternate group required an average of 5.2 injections, while the anti-VEGF received 4.2 injections (P < 0.001). In a propensity score-matched cohort to compensate for the differences in the injection numbers between the two groups, the alternate group achieved a better visual acuity gain than the anti-VEGF group at month 12 (0.39 logMAR vs. 0.17 logMAR, P=0.048).ConclusionsIn ME secondary to RVO, treatment with intravitreal corticosteroid and anti-VEGF injections alternately resulted in a more favorable visual outcome compared with intravitreal anti-VEGF monotherapy.
| S-EPMC8492286 | biostudies-literature
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.
| S-EPMC6098881 | biostudies-literature
Project description:Importance:The comparative clinical effectiveness of ranibizumab, aflibercept, and bevacizumab for the management of macular edema due to central retinal vein occlusion (CRVO) is unclear. Objective:To determine whether intravitreal aflibercept or bevacizumab compared with ranibizumab results in a noninferior mean change in vision at 100 weeks for eyes with CRVO-related macular edema. Design, Setting, and Participants:This prospective, 3-arm, double-masked, randomized noninferiority trial (Lucentis, Eylea, Avastin in Vein Occlusion [LEAVO] Study) took place from December 12, 2014, through December 16, 2016, at 44 UK National Health Service ophthalmology departments. Inclusion criteria included age 18 years or older, visual impairment due to CRVO-related macular edema of less than 12 months with best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score (approximate Snellen equivalent) in the study eye between 19 (20/400) and 78 (20/32), and spectral domain optical coherence tomography imaging central subfield thickness of 320 ?m or greater. Data were analyzed from March 4, 2019, to April 26, 2019. Interventions:Participants were randomized (1:1:1) to receive repeated intravitreal injections of ranibizumab (0.5 mg/0.05 mL) (n?=?155), aflibercept (2.0 mg/0.05 mL) (n?=?154), or bevacizumab (1.25 mg/0.05 mL) (n?=?154) for 100 weeks. Main Outcomes and Measures:Adjusted mean change in BCVA in the study eye at 100 weeks wherein noninferiority was concluded if the lower bounds of the 95% CI of both the intention-to-treat and the per protocol analyses were above -5 letters. Results:Of 463 participants, 265 (57.2%) were male, with a mean (SD) age of 69.1 (13.0) years. The mean (SD) gain in BCVA letter score was 12.5 (21.1) for ranibizumab, 15.1 (18.7) for aflibercept, and 9.8 (21.4) for bevacizumab at 100 weeks. Aflibercept was noninferior to ranibizumab (intention-to-treat-adjusted mean BCVA difference, 2.23 letters; 95% CI, -2.17 to 6.63 letters; P?<?.001). Bevacizumab was not noninferior to ranibizumab (intention-to-treat-adjusted mean BCVA difference, -1.73 letters; 95% CI, -6.12 to 2.67 letters; P?=?.07). The per protocol analysis conclusions were similar. Fewer mean injections were given in the aflibercept group (10.0) than in the ranibizumab (11.8) group (mean difference at 100 weeks, -1.9; 95% CI, -2.9 to -0.8). Conclusions and Relevance:Mean changes in vision after treatment of macular edema due to CRVO were no worse using aflibercept compared with ranibizumab. Mean changes in vision using bevacizumab compared with ranibizumab were inconclusive regarding vision outcomes (ie, the change in visual acuity from baseline, on average, may be worse or may not be worse when using bevacizumab compared with ranibizumab). Trial Registration:ISRCTN13623634.
| S-EPMC6865295 | biostudies-literature
Project description:ObjectiveTo compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).MethodsMulticenter, randomized, clinical trial of 271 participants.Main outcome measureGain in visual acuity letter score of 15 or more from baseline to month 12.ResultsSeven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.ConclusionsIntravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
| S-EPMC2872173 | biostudies-literature
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.
| S-EPMC3808377 | biostudies-literature