Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

Phase 2

Completed

• Conditions: Vogt Koyanagi Harada Disease
• Interventions: Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

• Registration Number: NCT05031143
• Lead Sponsor: Benha University

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-08-24
• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-31
• Status Verified: 2021-09
• Study First Posted: 2021-09-01
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCTA injection (n=6 eyes)	Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease	Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (LogMAR units)	6 months after injection	Changes in vision from baseline upto 6 months follow up

Secondary Outcome Measures

Name	Time	Method
Central Foveal Thickness measured by Optical Coherence Tomography	Upto 6 months after SCTA injection	Changes in CFT during 6 months after injection

Trial Locations

Locations (1)

Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT; 🇪🇬 Banhā, Qualiobeya, Egypt