This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Corona Virus on Intravitreal Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05494775
Recruitment Status : Recruiting
First Posted : August 10, 2022
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdelshafy, Benha University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Age-Related Macular Degeneration Choroidal Neovascularization Myopic Choroidal Neovascularisation Diabetic Retinopathy Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Corona Virus Pandemic on Intravitreal Injections
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 11, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05494775


Contacts
Layout table for location contacts
Contact: Ahmed A Tabl, MD 01222328766 ahmad4lg@gmail.com

Locations
Layout table for location information
Egypt
Ahmed Abdelshafy Tabl Recruiting
Banhā, Benha, Egypt, 13511
Contact: Ahmed A Tabl    01222328766    ahmad4lg@gmail.com   
Sponsors and Collaborators
Benha University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed A Tabl Benha University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed Abdelshafy, Associate professor of Ophthalmology, Benha University
ClinicalTrials.gov Identifier: NCT05494775    
Other Study ID Numbers: Rc-11-2022
First Posted: August 10, 2022    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Macular Degeneration
Macular Edema
Diabetic Retinopathy
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs