Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

Benha University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vogt Koyanagi Harada Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05031143

FDASU-RECD-1234441

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 47 to 52 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

SCTA injection (n=6 eyes)

Active Comparator group

Description:

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

Treatment:

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

Non-injected eyes (Standard Treatment) (n=6 eyes)

No Intervention group

Description:

Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months