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Use of Ziv Aflibercept in Different Retinal Diseases

Primary Purpose

Central Retinal Vein Occlusion With Macular Edema

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ziv-Aflibercept 25 MG/ML [Zaltrap]
Sponsored by
Amin El Sayed Nawar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion With Macular Edema focused on measuring myopic choroidal neovascularisation

Eligibility Criteria

31 Years - 63 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ziv aflibercept patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2020
Last Updated
October 4, 2021
Sponsor
Amin El Sayed Nawar
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04290195
Brief Title
Use of Ziv Aflibercept in Different Retinal Diseases
Official Title
Safety and Efficacy of Ziv Aflibercept in Myopic Choroidal Neovascularisation ,Central Retinal Vein Occlusion and Resistant Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amin El Sayed Nawar
Collaborators
Tanta University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion With Macular Edema
Keywords
myopic choroidal neovascularisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ziv aflibercept patients
Arm Type
Experimental
Arm Description
20 eyes of myopic CNV,20 eyes with resistant diabetic macular edema and 15 eyes with non ischaemic CRVO
Intervention Type
Drug
Intervention Name(s)
Ziv-Aflibercept 25 MG/ML [Zaltrap]
Other Intervention Name(s)
zaltrap
Intervention Description
Intravitreal injection of 1.25 mg of ziv aflibercept in patients
Primary Outcome Measure Information:
Title
Improvement of BCVA by log MAR(minimum angle of resolution) and reduction of CMT after intravitreal injection
Description
To assess sustained improvement of BCVA(Best corrected visual acuity) and reduction of the CMT (central macular thickness) after intravitreal injection of zivaflibercept
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
ZIP/Postal Code
31111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16234465
Citation
Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Choroidal neovascularisation in pathological myopia: an update in management. Br J Ophthalmol. 2005 Nov;89(11):1522-8. doi: 10.1136/bjo.2005.074716.
Results Reference
result
PubMed Identifier
35768859
Citation
Nawar AE, Wasfy T, Shafik HM. Switching to ziv-aflibercept in resistant diabetic macular edema non responsive to ranibizumab injection. BMC Ophthalmol. 2022 Jun 29;22(1):287. doi: 10.1186/s12886-022-02503-x.
Results Reference
derived
PubMed Identifier
33076864
Citation
Nawar AE, Shafik HM. Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients. BMC Ophthalmol. 2020 Oct 19;20(1):414. doi: 10.1186/s12886-020-01679-4.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov
Description
medical journal that contains multiple papers

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Use of Ziv Aflibercept in Different Retinal Diseases

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