NCT04290195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

February 23, 2020

Last Update Submit

October 4, 2021

Conditions

Central Retinal Vein Occlusion With Macular Edema

Keywords

myopic choroidal neovascularisation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

ziv aflibercept patients

EXPERIMENTAL

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]

Interventions

Ziv-Aflibercept 25 MG/ML [Zaltrap]DRUG

Intravitreal injection of 1.25 mg of ziv aflibercept in patients

Also known as: zaltrap
ziv aflibercept patients

Eligibility Criteria

Age31 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El Gharbia, 31111, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 16234465RESULT

  • 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.

    PMID: 35768859DERIVED

  • 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.

    PMID: 33076864DERIVED

Related Links

MeSH Terms

Interventions

aflibercept

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Resistant diabetic macular edema,non ischaemic central retinal vein occlusion and myopic choroidal neovascularisation
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Amin Nawar MD.Lecturer of Ophthalmology

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 28, 2020

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

October 11, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)