Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

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

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

Study Overview

• Status: Completed
• Conditions: Vogt Koyanagi Harada Disease
• Intervention / Treatment: Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Qualiobeya
    • Banhā, Qualiobeya, Egypt, 13511
      • Ophthalmology department,Benha University and Ebsar eye center,Benha,EGYPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SCTA injection (n=6 eyes); Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.	Drug: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease; Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease; Other Names: SCTA for Exudative RD in VKH disease
No Intervention: Non-injected eyes (Standard Treatment) (n=6 eyes); Non-injected eyes on systemic steroids (standard treatment) and follow up for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity (LogMAR units)	Changes in vision from baseline upto 6 months follow up	6 months after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Foveal Thickness measured by Optical Coherence Tomography	Changes in CFT during 6 months after injection	Upto 6 months after SCTA injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure measured by Goldmann applanation tonometry	Changes in IOP during 6 months follow up	6 months after injection

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Ahmed Abdelshafy, MD, Benha University, Faculty of medicine; Study Director: Marwa Abdelshafy, MD, Benha University, Faculty of medicine; Study Chair: Mohamed Anany, MD, Benha University, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Vogt-koyanagi Harada, Suprachoroidal injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Eye Diseases; Retinal Diseases; Uveitis; Uveal Diseases; Retinal Detachment; Uveomeningoencephalitic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: FDASU-RECD-1234441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No