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

Sponsor

Benha University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05496530

Collaborator

(none)

100

Enrollment

Location

Arms

13.2

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema Vogt Koyanagi Harada Disease Retinal Vein Occlusion	Drug: Suprachoroidal triamcinolone acetonide injection	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2022

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Diabetic macular edema Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.	Drug: Suprachoroidal triamcinolone acetonide injection Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Active Comparator: Vogt-koyanagi harada Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.	Drug: Suprachoroidal triamcinolone acetonide injection Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Active Comparator: Retinal vein occlusion Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.	Drug: Suprachoroidal triamcinolone acetonide injection Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Arm

Intervention/Treatment

Active Comparator: Diabetic macular edema

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

Drug: Suprachoroidal triamcinolone acetonide injection

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Active Comparator: Vogt-koyanagi harada

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

Drug: Suprachoroidal triamcinolone acetonide injection

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Active Comparator: Retinal vein occlusion

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

Drug: Suprachoroidal triamcinolone acetonide injection

Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

Outcome Measures

Primary Outcome Measures

Visual acuity [Baseline and up to one year after injection.]
Changes noted in vision after injection measured 8n logMar units by snellen chart.

Secondary Outcome Measures

Central macular thickness [Baseline and up to one year after injection.]
Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.

Other Outcome Measures

Intraocular pressure [Baseline and up to one year after injection.]
Changes noted in intraocular pressure after injection measured by applanation tonometry in millimeter mercury.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.