NCT04290195

Use of Ziv Aflibercept in Different Retinal Diseases

Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Amin El Sayed Nawar · Academic / Other
• Sex: All
• Age: 31 Years – 63 Years
• Healthy volunteers: Accepted

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.

Conditions

• Central Retinal Vein Occlusion With Macular Edema

Interventions

Type	Name	Description
DRUG	Ziv-Aflibercept 25 MG/ML [Zaltrap]	Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Timeline

• Start date: 2019-06-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2020-02-28
• Last updated: 2021-10-11

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study