Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)
One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases
1 other identifier
interventional
100
1 country
1
Brief Summary
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedAugust 11, 2022
August 1, 2022
1.1 years
August 9, 2022
August 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
Changes noted in vision after injection measured 8n logMar units by snellen chart.
Baseline and up to one year after injection.
Secondary Outcomes (1)
Central macular thickness
Baseline and up to one year after injection.
Other Outcomes (1)
Intraocular pressure
Baseline and up to one year after injection.
Study Arms (3)
Diabetic macular edema
ACTIVE COMPARATORCases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.
Vogt-koyanagi harada
ACTIVE COMPARATORCases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.
Retinal vein occlusion
ACTIVE COMPARATORCases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.
Interventions
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
- Cases with confirmed diagnosis of glaucoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed A Tabl
Benha University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Ophthalmology
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
July 10, 2022
Primary Completion
July 30, 2023
Study Completion
August 15, 2023
Last Updated
August 11, 2022
Record last verified: 2022-08