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Use of Ziv Aflibercept in Different Retinal Diseases

Sponsor
Amin El Sayed Nawar (Other)
Overall Status
Completed
CT.gov ID
NCT04290195
Collaborator
Tanta University (Other)
55
Enrollment
1
Location
1
Arm
7
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisationResistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ziv aflibercept patients

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]
Intravitreal injection of 1.25 mg of ziv aflibercept in patients
Other Names:
  • zaltrap

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection [6 months]

      To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    31 Years to 63 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Tanta El Gharbia Egypt 31111

    Sponsors and Collaborators

    • Amin El Sayed Nawar
    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amin El Sayed Nawar, Amin Nawar MD.Lecturer of Ophthalmology, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04290195
    Other Study ID Numbers:
    • 2AA
    First Posted:
    Feb 28, 2020
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Amin El Sayed Nawar, Amin Nawar MD.Lecturer of Ophthalmology, Tanta University
    myopic choroidal neovascularisation
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Vein Occlusion
    Choroidal Neovascularization
    Aflibercept

    Study Results

    No Results Posted as of Oct 11, 2021