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Clinical Trials/NCT05031143
NCT05031143
Completed
Phase 2

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

Benha University1 site in 1 country6 target enrollmentApril 1, 2020

Overview

Phase
Phase 2
Intervention
Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease
Conditions
Vogt Koyanagi Harada Disease
Sponsor
Benha University
Enrollment
6
Locations
1
Primary Endpoint
Best Corrected Visual Acuity (LogMAR units)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
August 24, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdelshafy

Lecturer of Ophthalmology

Benha University

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.

Arms & Interventions

SCTA injection (n=6 eyes)

Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.

Intervention: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (LogMAR units)

Time Frame: 6 months after injection

Changes in vision from baseline upto 6 months follow up

Secondary Outcomes

  • Central Foveal Thickness measured by Optical Coherence Tomography(Upto 6 months after SCTA injection)

Study Sites (1)

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