Back to resultsSuprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
Primary Purpose
Vogt Koyanagi Harada Disease
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
Sponsored by
About this trial
This is an interventional treatment trial for Vogt Koyanagi Harada Disease focused on measuring Vogt-koyanagi Harada, Suprachoroidal injection
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.
Exclusion Criteria:
- recent intraocular surgery.
- patients refuse to participate in the study.
- media opacity and other causes of serous retinal detachment than VKH.
Sites / Locations
- Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
SCTA injection (n=6 eyes)
Non-injected eyes (Standard Treatment) (n=6 eyes)
Arm Description
Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.
Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity (LogMAR units)
Changes in vision from baseline upto 6 months follow up
Secondary Outcome Measures
Central Foveal Thickness measured by Optical Coherence Tomography
Changes in CFT during 6 months after injection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05031143
Brief Title
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
Official Title
Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection
Detailed Description
Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which was detectable for more than 3 months with limited exposure in the anterior segment. Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated in this study. The aim of this study was to assess the efficacy of suprachoroidal Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT) by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic, Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vogt Koyanagi Harada Disease
Keywords
Vogt-koyanagi Harada, Suprachoroidal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCTA injection (n=6 eyes)
Arm Type
Active Comparator
Arm Description
Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.
Arm Title
Non-injected eyes (Standard Treatment) (n=6 eyes)
Arm Type
No Intervention
Arm Description
Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months
Intervention Type
Drug
Intervention Name(s)
Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
Other Intervention Name(s)
SCTA for Exudative RD in VKH disease
Intervention Description
Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (LogMAR units)
Description
Changes in vision from baseline upto 6 months follow up
Time Frame
6 months after injection
Secondary Outcome Measure Information:
Title
Central Foveal Thickness measured by Optical Coherence Tomography
Description
Changes in CFT during 6 months after injection
Time Frame
Upto 6 months after SCTA injection
Other Pre-specified Outcome Measures:
Title
Intraocular pressure measured by Goldmann applanation tonometry
Description
Changes in IOP during 6 months follow up
Time Frame
6 months after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.
Exclusion Criteria:
recent intraocular surgery.
patients refuse to participate in the study.
media opacity and other causes of serous retinal detachment than VKH.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
Organizational Affiliation
Benha University, faculty of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marwa Abdelshafy, MD
Organizational Affiliation
Benha University, faculty of medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Anany, MD
Organizational Affiliation
Benha University, faculty of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT
City
Banhā
State/Province
Qualiobeya
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment
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