Use of Ziv Aflibercept in Different Retinal Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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

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Central Retinal Vein Occlusion With Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ziv aflibercept patients

20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO

Group Type EXPERIMENTAL

Ziv-Aflibercept 25 MG/ML [Zaltrap]

Intervention Type DRUG

Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Interventions

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Ziv-Aflibercept 25 MG/ML [Zaltrap]

Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Intervention Type DRUG

Other Intervention Names

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zaltrap

Eligibility Criteria

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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

Minimum Eligible Age

31 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes