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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
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04290195
Enrollment
55
Registered
2020-02-28
Start date
2019-06-01
Completion date
2020-01-01
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Retinal Vein Occlusion With Macular Edema

Keywords

myopic choroidal neovascularisation

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.

Interventions

Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Sponsors

Tanta University
CollaboratorOTHER
Amin El Sayed Nawar
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
31 Years to 63 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection6 monthsTo assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026