Back to resultsCustom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)
Primary Purpose
Diabetic Macular Edema, Vogt Koyanagi Harada Disease, Retinal Vein Occlusion
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suprachoroidal triamcinolone acetonide injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
- Diabetic macular edema
- Vogt-koyanagi Harada disease
- Retinal vein occlusion.
Exclusion Criteria:
- other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
- Cases with confirmed diagnosis of glaucoma.
Sites / Locations
- Ahmed Abdelshafy TablRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Diabetic macular edema
Vogt-koyanagi harada
Retinal vein occlusion
Arm Description
Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.
Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.
Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.
Outcomes
Primary Outcome Measures
Visual acuity
Changes noted in vision after injection measured 8n logMar units by snellen chart.
Secondary Outcome Measures
Central macular thickness
Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05496530
Brief Title
Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)
Official Title
One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 15, 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
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.
Detailed Description
In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Vogt Koyanagi Harada Disease, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetic macular edema
Arm Type
Active Comparator
Arm Description
Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.
Arm Title
Vogt-koyanagi harada
Arm Type
Active Comparator
Arm Description
Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.
Arm Title
Retinal vein occlusion
Arm Type
Active Comparator
Arm Description
Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.
Intervention Type
Drug
Intervention Name(s)
Suprachoroidal triamcinolone acetonide injection
Intervention Description
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Primary Outcome Measure Information:
Title
Visual acuity
Description
Changes noted in vision after injection measured 8n logMar units by snellen chart.
Time Frame
Baseline and up to one year after injection.
Secondary Outcome Measure Information:
Title
Central macular thickness
Description
Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.
Time Frame
Baseline and up to one year after injection.
Other Pre-specified Outcome Measures:
Title
Intraocular pressure
Description
Changes noted in intraocular pressure after injection measured by applanation tonometry in millimeter mercury.
Time Frame
Baseline and up to one year after injection.
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:
cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
Diabetic macular edema
Vogt-koyanagi Harada disease
Retinal vein occlusion.
Exclusion Criteria:
other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
Cases with confirmed diagnosis of glaucoma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Tabl
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
Ext
Tabl
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed A Tabl, MD
12. IPD Sharing Statement
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Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)
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