Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease

Conditions
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Vogt Koyanagi Harada Disease

Intervention / Treatment
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* Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SCTA injection (n=6 eyes)<br>Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months. | Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease<br>* Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease<br>* Other names: SCTA for Exudative RD in VKH disease;|
| No Intervention: Non-injected eyes (Standard Treatment) (n=6 eyes)<br>Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (LogMAR units) | Changes in vision from baseline upto 6 months follow up | 6 months after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Foveal Thickness measured by Optical Coherence Tomography | Changes in CFT during 6 months after injection | Upto 6 months after SCTA injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vogt-koyanagi Harada, Suprachoroidal injection