Back to resultsEffect of Corona Virus on Intravitreal Injections
Primary Purpose
Diabetic Macular Edema, Age-Related Macular Degeneration, Choroidal Neovascularization
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anti-vascular endothelial growth factors (Anti-VEGFs)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility 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.
Sites / Locations
- Ahmed Abdelshafy TablRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Diabetic macular edema
Wet age related macular edema
Retinal vein occlusion
Myopic choroidal new vascularization
Arm Description
Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Outcomes
Primary Outcome Measures
Visual acuity
Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.
Secondary Outcome Measures
Central subfield thickness
Assessing the changes in central macular thickness in microns measured by optical coherence tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494775
Brief Title
Effect of Corona Virus on Intravitreal Injections
Official Title
Effects of Corona Virus Pandemic on Intravitreal Injections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 11, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Age-Related Macular Degeneration, Choroidal Neovascularization, Myopic Choroidal Neovascularisation, Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetic macular edema
Arm Type
Active Comparator
Arm Description
Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Arm Title
Wet age related macular edema
Arm Type
Active Comparator
Arm Description
Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Arm Title
Retinal vein occlusion
Arm Type
Active Comparator
Arm Description
Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Arm Title
Myopic choroidal new vascularization
Arm Type
Active Comparator
Arm Description
Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors.
Intervention Type
Drug
Intervention Name(s)
Anti-vascular endothelial growth factors (Anti-VEGFs)
Intervention Description
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
Primary Outcome Measure Information:
Title
Visual acuity
Description
Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.
Time Frame
Baseline and monthly after injection till one year of follow-up
Secondary Outcome Measure Information:
Title
Central subfield thickness
Description
Assessing the changes in central macular thickness in microns measured by optical coherence tomography
Time Frame
Baseline and monthly after injection till one year of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Tabl, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy Tabl
City
Banhā
State/Province
Benha
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl
Phone
01222328766
Email
ahmad4lg@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Corona Virus on Intravitreal Injections
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