Effect of Corona Virus on Intravitreal Injections

August 8, 2022 updated by: Ahmed Abdelshafy, Benha University

Effects of Corona Virus Pandemic on Intravitreal Injections

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetic macular edema
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)
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Wet age related macular edema
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)
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Retinal vein occlusion
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)
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Active Comparator: Myopic choroidal new vascularization
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)
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Baseline and monthly after injection till one year of follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central subfield thickness
Time Frame: Baseline and monthly after injection till one year of follow-up
Assessing the changes in central macular thickness in microns measured by optical coherence tomography
Baseline and monthly after injection till one year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed A Tabl, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

June 11, 2023

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc-11-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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