Use of Ziv Aflibercept in Different Retinal Diseases

Amin El Sayed Nawar

Status and phase

Completed

Phase 2

Phase 1

Conditions

Central Retinal Vein Occlusion With Macular Edema

Treatments

Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]

Study type

Interventional

Funder types

Other

Identifiers

NCT04290195

2AA

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

31 to 63 years old

Volunteers

Accepts Healthy Volunteers

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