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

B

Baghdad college of medicine

Status and phase

Enrolling
Early Phase 1

Conditions

Non Infectious Uveitis
Macular Edema (ME)

Treatments

Drug: Suprachoroidal triamcinolone acetonide injection

Study type

Interventional

Funder types

Other

Identifiers

NCT07145008
2024-234

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Suprachoroidal Triamcinolone treatment arm
Experimental group
Treatment:
Drug: Suprachoroidal triamcinolone acetonide injection

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Mohammed Suhail Al-Salam

Data sourced from clinicaltrials.gov

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