Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

Vogt Koyanagi Harada Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031143
• Other study ID #: FDASU-RECD-1234441
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: September 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 24, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 47 Years to 52 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Detachment
• Uveomeningoencephalitic Syndrome
• Vogt Koyanagi Harada Disease

Intervention

Drug:
• Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease

Locations

Country	Name	City	State
Egypt	Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT	Banha	Qualiobeya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure measured by Goldmann applanation tonometry	Changes in IOP during 6 months follow up	6 months after injection
Primary	Best Corrected Visual Acuity (LogMAR units)	Changes in vision from baseline upto 6 months follow up	6 months after injection
Secondary	Central Foveal Thickness measured by Optical Coherence Tomography	Changes in CFT during 6 months after injection	Upto 6 months after SCTA injection