Use of Ziv Aflibercept in Different Retinal Diseases

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Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеЗавършен

Спонсори

Amin El Sayed Nawar

Сътрудници

Tanta University

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT04290195

BioSeek: nct04290195

Ключови думи

Резюме

A prospective interventional case series study was conducted on 20 eyes of 20 patients with active myopic choroidal neovascularisation (CNV) ,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic central retinal vein occlusion(CRVO) after approval of the Ethical Committee of the Faculty of Medicine, Tanta University . All procedures were carried out under the tenets of the Helsinki Declaration. Written consent was provided by all participants after discussing the procedure, alternative treatment plans, follow-up schedules, and possible benefits and risks.

Описание

Intravitreal injection of 1.25 mg of ziv aflibercept was done in different retinal diseases including myopic CVN,resistant diabetic macular edema to previous ranibizumab injection and non ischaemic CRVO .Thorough ophthalmic evaluation was done including BCVA(best corrected visual acuity) ,anterior and posterior segment examination ,fundus fluorescein angiography and OCT(optical coherence tomography) were performed for all patients .Injection was repeated as PRN(pro re nata) method after one month if persistent intraretinal or subretinal fluid was found.

Дати

Последна проверка:	01/31/2020
Първо изпратено:	02/22/2020
Очаквано записване подадено:	02/25/2020
Първо публикувано:	02/27/2020
Изпратена последна актуализация:	02/25/2020
Последна актуализация публикувана:	02/27/2020
Действителна начална дата на проучването:	05/31/2019
Приблизителна дата на първично завършване:	11/30/2019
Очаквана дата на завършване на проучването:	12/31/2019

Състояние или заболяване

Central Retinal Vein Occlusion With Macular Edema

Интервенция / лечение

Drug: ziv aflibercept patients

Фаза

Фаза 1/Фаза 2

Групи за ръце

Arm	Интервенция / лечение
Experimental: ziv aflibercept patients 20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO	Drug: ziv aflibercept patients Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	31 Years Да се 31 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	Inclusion Criteria: - The study included treatment naive patients suffering from recently diagnosed active myopic subfoveal or juxtafoveal CNV less than 2 months documented by fundus fluorescein angiography (FFA)and optical coherence tomography (OCT ) , pathological myopia more than 6 D was included . Exclusion Criteria: - Previous intraocular surgery . - Coincident retinal pathology as diabetic retinopathy, retinal vein occlusion . - CNV due to other causes like age related macular degeneration ,angioid streaks,trauma and choroiditis. - Extrafoveal myopic CNV . - Patients received other lines of treatment for CNV like photodynamic therapy ,laser photocoagulation or intravitreal injection of triamcinolone or other anti VEGF(vascular endothelial growth factor) agents. - Known glaucoma , clinical suspicion of glaucoma or IOP(intraocular pressure) more than 20 mmHg. - Prior ocular inflammation. - The presence of retinal degeneration. - Patients who didnot complete 6 months of follow up

Резултат

Първични изходни мерки

1. Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection [6 months]

To assess if there is improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept