Use of Ziv Aflibercept in Different Retinal Diseases

Phase 1

Completed

• Conditions: Central Retinal Vein Occlusion With Macular Edema
• Interventions: Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]

• Registration Number: NCT04290195
• Lead Sponsor: Amin El Sayed Nawar

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ziv aflibercept patients	Ziv-Aflibercept 25 MG/ML [Zaltrap]	20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO

Primary Outcome Measures

Name	Time	Method
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection	6 months	To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt