Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon

NCT ID: NCT07145008

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-01

Brief Summary

The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection).

The main questions it aims to answer are:

Does vision improve on the eye chart after the injection?

Does the injection lower retinal swelling (reduction in thickness) within 3 months?

Participants will:

Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT).

Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring.

Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans.

Contact the clinic if they notice pain, redness, new floaters, or worsening vision.

Conditions

Macular Edema (ME); Non Infectious Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Suprachoroidal Triamcinolone treatment arm

Group Type: EXPERIMENTAL

Suprachoroidal triamcinolone acetonide injection

Intervention Type: DRUG

For suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth.

Interventions

Suprachoroidal triamcinolone acetonide injection

For suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-infectious uveitis complicated with macular edema
• Uveitic macular edema of less than four months' duration
• Macular edema persisted despite lack of intra-ocular inflammation
• No response to posterior sub-Tenon triamcinolone acetonide injections

Exclusion Criteria

• Those with epiretinal membrane-associated macular edema
• Below 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baghdad college of medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Mutar

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ibn Al-Haitham Eye Teaching Hospital

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Mohammed Suhail Al-Salam

Role: CONTACT

mohammedsuhail@uomustansiriyah.edu.iq

+964 790 183 6367

Facility Contacts

Mohammed Suhail Al-Salam

Role: primary

mohammedsuhail@uomustansiriyah.edu.iq

+964 790 183 6367

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024-234

Identifier Type: -

Identifier Source: org_study_id