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EFFICACY AND SAFETY OF INTRAVITREAL CONBERCEPT INJECTIONS IN MACULAR EDEMA SECONDARY TO RETINAL VEIN OCCLUSION.

ABSTRACT: 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.

SUBMITTER: Sun Z

PROVIDER: S-EPMC5598918 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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EFFICACY AND SAFETY OF INTRAVITREAL CONBERCEPT INJECTIONS IN MACULAR EDEMA SECONDARY TO RETINAL VEIN OCCLUSION.

Sun Zuhua Z Zhou Haiying H Lin Bing B Jiao Xuan X Luo Yingdong Y Zhang Feng F Tao Shanshan S Wu Quan Q Ke Zunhong Z Liu Xiaoling X

Retina (Philadelphia, Pa.) 20170901 9

<h4>Purpose</h4>To assess the efficacy and safety of intravitreal conbercept injections in patients with macular edema secondary to retinal vein occlusion (RVO).<h4>Methods</h4>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 ...[more]

PMID: 27893623

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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: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:OBJECTIVES:To evaluate the efficacy and safety of anti-vascular endothelial growth factor (VEGF) agents and corticosteroids for the treatment of macular oedema (ME) secondary to central retinal vein occlusion (CRVO). DESIGN:Systematic review and network meta-analysis. PARTICIPANTS:Patients from previously reported randomised controlled trials (RCTs) comparing anti-VEGF and corticosteroids for the treatment of ME secondary to CRVO. METHODS:Literature searches were conducted using PubMed, Medline, Embase, Cochrane Library and clinicaltrials.gov until March 2017. Therapeutic effects were estimated using the proportions of patients gaining/losing ?15 letters, best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Treatment safety was estimated using the proportions of adverse events, namely increased intraocular pressure (IOP), cataracts, vitreous haemorrhage (VH) and retinal tear. The software ADDIS (V.1.16.8) was used for analysis. Treatment effect and safety of different drugs could be ranked based on simulation. RESULTS:Eleven RCTs comprising 2060 patients were identified. Regarding patients gaining ?15 letters, aflibercept and ranibizumab were significantly more effective than sham/placebo at 6 months. Regarding patients losing ?15 letters at 6 months, ranibizumab showed significant improvement compared with dexamethasone. Aflibercept, bevacizumab or ranibizumab showed greater improvements in BCVA than sham/placebo at 6 months. Intravitreal ranibizumab injection demonstrated greater CRT reduction than both sham and dexamethasone did. Dexamethasone had a higher risk of increased IOP than aflibercept and ranibizumab. Ranibizumab demonstrated a greater risk of cataracts than dexamethasone. Aflibercept and ranibizumab demonstrated low incidence of VH and retinal tear, respectively. Aflibercept had a slight advantage over ranibizumab as assessed by benefit-risk analysis. CONCLUSIONS:Anti-VEGF agents have advantages in the treatment of ME secondary to CRVO. Aflibercept and ranibizumab showed marked BCVA improvement and CRT reduction. Aflibercept may have a slight advantage over ranibizumab. The results of this study can serve as a reference for clinicians to provide patient-tailored treatment. PROSPERO REGISTRATION NUMBER:CRD42017064076.

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.

Dataset Information

EFFICACY AND SAFETY OF INTRAVITREAL CONBERCEPT INJECTIONS IN MACULAR EDEMA SECONDARY TO RETINAL VEIN OCCLUSION.

Publications

EFFICACY AND SAFETY OF INTRAVITREAL CONBERCEPT INJECTIONS IN MACULAR EDEMA SECONDARY TO RETINAL VEIN OCCLUSION.

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