NCT05494775

Brief Summary

During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

4.4 years

First QC Date

August 8, 2022

Last Update Submit

August 8, 2022

Conditions

Diabetic Macular EdemaAge-Related Macular DegenerationChoroidal NeovascularizationMyopic Choroidal NeovascularisationDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.

    Baseline and monthly after injection till one year of follow-up

Secondary Outcomes (1)

  • Central subfield thickness

    Baseline and monthly after injection till one year of follow-up

Study Arms (4)

Diabetic macular edema

ACTIVE COMPARATOR

Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors.

Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)

Wet age related macular edema

ACTIVE COMPARATOR

Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors.

Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)

Retinal vein occlusion

ACTIVE COMPARATOR

Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors.

Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)

Myopic choroidal new vascularization

ACTIVE COMPARATOR

Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors.

Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)

Interventions

Anti-vascular endothelial growth factors (Anti-VEGFs)DRUG

Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).

Diabetic macular edemaMyopic choroidal new vascularizationRetinal vein occlusionWet age related macular edema

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema).

You may not qualify if:

  • patients that are known to have hypersensitivity to Anti-VEGFs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy Tabl

Banhā, Benha, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Macular DegenerationChoroidal NeovascularizationDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ahmed A Tabl

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Tabl, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

February 1, 2019

Primary Completion

June 11, 2023

Study Completion

July 30, 2023

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)