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Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial

Current controlled trials in cardiovascular medicine, 2024-04, Vol.25 (1), p.244-244 [Peer Reviewed Journal]

2024. The Author(s). ;COPYRIGHT 2024 BioMed Central Ltd. ;The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;The Author(s) 2024 ;ISSN: 1745-6215 ;EISSN: 1745-6215 ;EISSN: 1468-6694 ;DOI: 10.1186/s13063-024-08082-0 ;PMID: 38589960

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Title:
Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial
Author: Yao, Bangtao ; Wang, Bei ; Yang, Jun ; Geng, Yan ; Yu, Hao ; Liu, Yuhui ; Liu, Gang ; Wang, Xiuying
Subjects: Angiogenesis Inhibitors ; Anti-vascular endothelial growth factor ; Antilipemic agents ; Atherosclerosis ; Atorvastatin ; Atorvastatin - adverse effects ; Best-corrected visual acuity ; Biochemistry ; Blood tests ; Care and treatment ; Carotid plaques ; Cataracts ; Central subfield thickness ; Clinical trials ; Data collection ; Diabetes ; Diabetic retinopathy ; Diagnosis ; Dosage and administration ; Dropsy ; Drug therapy ; Drug therapy, Combination ; Drug withdrawal ; Drugs ; Edema ; Glaucoma ; Health aspects ; Hepatitis ; Humans ; Infections ; Intravitreal conbercept ; Macular degeneration ; Macular Edema - diagnosis ; Macular Edema - drug therapy ; Macular Edema - etiology ; Medical imaging ; Ophthalmic drugs ; Patient outcomes ; Pharmaceuticals ; Product development ; Prospective Studies ; Randomized Controlled Trials as Topic ; Recombinant Fusion Proteins ; Retinal diseases ; Retinal Vein Occlusion - complications ; Retinal Vein Occlusion - diagnosis ; Retinal Vein Occlusion - drug therapy ; Study Protocol ; Surgery ; Syphilis ; Testing ; Tomography ; Tomography, Optical Coherence ; Treatment Outcome ; Ultrasonic imaging ; Vascular endothelial growth factor ; Veins & arteries ; Visual acuity
Is Part Of: Current controlled trials in cardiovascular medicine, 2024-04, Vol.25 (1), p.244-244
Description: Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP). A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student's t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance. The study has been approved by the Institutional Review Board of Nanjing Lishui People's Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal. Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023.
Publisher: England: BioMed Central Ltd
Language: English
Identifier: ISSN: 1745-6215
EISSN: 1745-6215
EISSN: 1468-6694
DOI: 10.1186/s13063-024-08082-0
PMID: 38589960
Source: Open Access: PubMed Central
Geneva Foundation Free Medical Journals at publisher websites
AUTh Library subscriptions: ProQuest Central
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Alma/SFX Local Collection
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ROAD: Directory of Open Access Scholarly Resources
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Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial

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