Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)

Diabetic Macular Edema Clinical Trial

Official title:

One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496530
• Other study ID #: Rc-11-22
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2022
• Source: Benha University
• Contact: Ahmed A Tabl
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.

Description:

In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:

• Diabetic macular edema

• Vogt-koyanagi Harada disease

• Retinal vein occlusion.

Exclusion Criteria:

• other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.

• Cases with confirmed diagnosis of glaucoma.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema
• Retinal Vein Occlusion
• Uveomeningoencephalitic Syndrome
• Vogt Koyanagi Harada Disease

Intervention

Drug:
• Suprachoroidal triamcinolone acetonide injection
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Locations

Country	Name	City	State
Egypt	Ahmed Abdelshafy Tabl	Banha	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraocular pressure	Changes noted in intraocular pressure after injection measured by applanation tonometry in millimeter mercury.	Baseline and up to one year after injection.
Primary	Visual acuity	Changes noted in vision after injection measured 8n logMar units by snellen chart.	Baseline and up to one year after injection.
Secondary	Central macular thickness	Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.	Baseline and up to one year after injection.