Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

NCT ID: NCT05031143

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-08-24

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.

Conditions

Vogt Koyanagi Harada Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCTA injection (n=6 eyes)

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

Group Type: ACTIVE_COMPARATOR

Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

Intervention Type: DRUG

Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease

Intervention Type: DRUG

Other Intervention Names

SCTA for Exudative RD in VKH disease

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.

• Minimum Eligible Age: 47 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdelshafy

Lecturer of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abdelshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University, faculty of medicine

Marwa Abdelshafy, MD

Role: STUDY_DIRECTOR

Benha University, faculty of medicine

Mohamed Anany, MD

Role: STUDY_CHAIR

Benha University, faculty of medicine

Locations

Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT

Banhā, Qualiobeya, Egypt

Countries

Egypt

Other Identifiers

FDASU-RECD-1234441

Identifier Type: -

Identifier Source: org_study_id