Clinical trial NCT05031143: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vogt Koyanagi Harada Disease
Keywords: Vogt-koyanagi Harada, Suprachoroidal injection
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 6
Sex: ALL
Minimum age (years): 47
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Best Corrected Visual Acuity (LogMAR units)
timeFrame: 6 months after injection
Secondary outcomes:
measure: Central Foveal Thickness measured by Optical Coherence Tomography
timeFrame: Upto 6 months after SCTA injection
Other outcomes:
measure: Intraocular pressure measured by Goldmann applanation tonometry
timeFrame: 6 months after injection
Locations:
city: Banhā
country: Egypt
facility: Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT
state: Qualiobeya
Study officials:
affiliation: Benha University, faculty of medicine
name: Ahmed Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University, faculty of medicine
name: Marwa Abdelshafy, MD
role: STUDY_DIRECTOR
affiliation: Benha University, faculty of medicine
name: Mohamed Anany, MD
role: STUDY_CHAIR
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