The Use of Suprachoroidal Triamcinolone Acetonide to Treat Macular Edema in Retinal Vein Occlusion

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This prospective non-randomized open-label interventional study aimed to evaluate feasibility in regard to potential efficacy and safety of triamcinolone acetonide (TA) injected in the suprachoroidal space (SCS) as a promising therapeutic route that provides a better bioavailability, longer sustained duration of action, and thus improved patients' compliance for the treatment of macular edema due to retinal vein occlusion (RVO).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damascus University
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

1. Male or nonpregnant female patients >18 years of age.

2. Has a clinical diagnosis of Retinal Vein Occlusion (RVO) in the study eye.

3. Best-Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score ≥ 20 (20/400 Snellen equivalent), and ≤75 in the study eye (20/32 Snellen equivalent).

4. Central Subfield Thickness (CST) ≥310 microns measured by Spectral Domain Optical Coherence Tomography (SD-OCT) in the study eye.

Exclusion Criteria:

1. Intravitreal (IVT) injection of anti-VEGF: Bevacizumab (Avastin; Genentech, South San Francisco, CA, USA/Roche, Basel, Switzerland) or ranibizumab (Lucentis; Genentech Inc., South San Francisco, CA, USA) within 1 month and aflibercept (Eylea®; Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA, and Bayer HealthCare Pharmaceuticals, Berlin, Germany) within 2 months in the study eye.

2. Intraocular or periocular corticosteroid injection within 3 months, dexamethasone implant (Ozurdex, Allergan, Dublin, Ireland) within 6 months, Retisert (Bausch and Lomb, Bridge water, NJ) within 1 year, or fluocinolone acetonide implant (Iluvien, Alimera Sciences, Alpharetta, GA) within 3 years in the study eye.

3. Macular laser photocoagulation treatment in the study eye.

4. Topical ophthalmic nonsteroidal anti-inflammatory drugs in the study eye within a month.

5. Any significant media opacity that could hinder the evaluation of the retina or ocular condition causing decreased vision other than RVO.

6. IOP >22 mm Hg, or history of steroid-induced ocular hypertension; uncontrolled glaucoma.

7. Past vitreoretinal or glaucoma surgery in the study eye.

8. Uncontrolled systemic disease that could hinder follow-up, immunodeficiency, or any other systemic contraindication for steroids.