Back to resultsResults of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
Primary Purpose
Central Serous Chorioretinopathy, Irvine-Gass Syndrome, Pars Planitis
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central serous chorioretinopathy, Cystoid macular edema
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.
Exclusion Criteria:
- other retinal diseases that may affect CMT and final visual outcome.
- Patients with dense corneal opacity.
Sites / Locations
- Ahmed AbdelshafyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Central serous chorioretinopathy group
Irvine-Gass Syndrome group
Arm Description
Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide.
Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide
Outcomes
Primary Outcome Measures
Central macular thickness
Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)
Secondary Outcome Measures
Best corrected visual acuity
Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05337332
Brief Title
Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
Official Title
Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 1, 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 injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.
Detailed Description
Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy, Irvine-Gass Syndrome, Pars Planitis, Cystoid Macular Edema
Keywords
Central serous chorioretinopathy, Cystoid macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Central serous chorioretinopathy group
Arm Type
Experimental
Arm Description
Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide.
Arm Title
Irvine-Gass Syndrome group
Arm Type
Experimental
Arm Description
Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Suprachoroidal triamcinolone acetonide injection (SCTA)
Intervention Description
Suprachoroidal injection of triamcinolone acetonide
Primary Outcome Measure Information:
Title
Central macular thickness
Description
Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)
Time Frame
Baseline and 12 months after injection.
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.
Time Frame
Baseline and 12 months after injection.
Other Pre-specified Outcome Measures:
Title
Intraocular pressure
Description
Changes in intraocular pressure (IOP) measured in millimeter mercury (mmHg) by applanation tonometry.
Time Frame
Baseline and 12 months after injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.
Exclusion Criteria:
other retinal diseases that may affect CMT and final visual outcome.
Patients with dense corneal opacity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy
Phone
01222328766
Email
ahmad4lg@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
We'll reach out to this number within 24 hrs