Use of Ziv Aflibercept in Different Retinal Diseases

Study Overview
=================
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.

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

Conditions
-----------------
Central Retinal Vein Occlusion With Macular Edema

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 31 Years
Maximum Age: 63 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ziv aflibercept patients<br>20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO | Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]<br>* Intravitreal injection of 1.25 mg of ziv aflibercept in patients<br>* Other names: zaltrap;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myopic choroidal neovascularisation