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

Benha University

Status: Enrolling

Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Vogt Koyanagi Harada Disease

Treatments: Drug: Suprachoroidal triamcinolone acetonide injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05496530

Rc-11-22

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Diabetic macular edema

Active Comparator group

Description:

Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.

Treatment:

Drug: Suprachoroidal triamcinolone acetonide injection

Vogt-koyanagi harada

Active Comparator group

Description:

Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.

Treatment:

Drug: Suprachoroidal triamcinolone acetonide injection

Retinal vein occlusion

Active Comparator group

Description:

Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.

Treatment:

Drug: Suprachoroidal triamcinolone acetonide injection