Skip to main content
OpenTrials
Completed

NCT Number: NCT05031143

Suprachoroidal Triamcinolone Acetonide in Harada's Retinal Detachment

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

47 year–52 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Banhā, Qualiobeya, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease

Drug

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

Other names: SCTA for Exudative RD in VKH disease

Primary outcomes

  1. Best Corrected Visual Acuity (LogMAR units)

    Time frame: 6 months after injection

    Changes in vision from baseline upto 6 months follow up

Secondary outcomes

  1. Central Foveal Thickness measured by Optical Coherence Tomography

    Time frame: Upto 6 months after SCTA injection

    Changes in CFT during 6 months after injection

Other outcomes

  1. Intraocular pressure measured by Goldmann applanation tonometry

    Time frame: 6 months after injection

    Changes in IOP during 6 months follow up

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2021
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.