Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- suprachoroidal injection of Triamcinolone Acetonide.
- Conditions
- Macular Edema
- Sponsor
- Damascus University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Percentage of participants with BCVA gain≥ 15 Letters at 3 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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).
Detailed Description
Management of Macular Edema (ME) associated with Retinal Vein Occlusion (RVO) still poses a therapeutic challenge taking into account its complicated etiopathogenesis. Despite improved visual and anatomical outcomes achieved by intravitreal injections of antiangiogenics and steroids, these treatments are still associated with non-responders, tachyphylaxis, rebound phenomenon, high re-injection, and adverse events rates, which underscore the importance of addressing new approaches to formulate treatment strategies. Delivery of therapeutic agents into the suprachoroidal space (SCS) provides a novel alternative approach that has theoretical appeal, as it dominantly targets chorioretinal tissues with the posterior and circumferential spread of the drug administered while relatively sparing the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects, which potentiates safety. This was well translated in preclinical and clinical studies through microinjector, which has been shown to provide a safe, minimally invasive, and reliable method of targeting SCS. In addition, sustained duration and favorable pharmacokinetics have been observed for small molecule suspensions including Triamcinolone Acetonide (TA), with the potential to reduce treatment burden.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or nonpregnant female patients \>18 years of age.
- •Has a clinical diagnosis of Retinal Vein Occlusion (RVO) in the study eye.
- •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).
- •Central Subfield Thickness (CST) ≥310 microns measured by Spectral Domain Optical Coherence Tomography (SD-OCT) in the study eye.
Exclusion Criteria
- •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.
- •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.
- •Macular laser photocoagulation treatment in the study eye.
- •Topical ophthalmic nonsteroidal anti-inflammatory drugs in the study eye within a month.
- •Any significant media opacity that could hinder the evaluation of the retina or ocular condition causing decreased vision other than RVO.
- •IOP \>22 mm Hg, or history of steroid-induced ocular hypertension; uncontrolled glaucoma.
- •Past vitreoretinal or glaucoma surgery in the study eye.
- •Uncontrolled systemic disease that could hinder follow-up, immunodeficiency, or any other systemic contraindication for steroids.
Arms & Interventions
4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection
Suprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.
Intervention: suprachoroidal injection of Triamcinolone Acetonide.
Outcomes
Primary Outcomes
Percentage of participants with BCVA gain≥ 15 Letters at 3 months
Time Frame: 3 months after injection
Percentage of participants with ≥ 15 letter Improvement from Baseline Best corrected visual acuity (BCVA) using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity score: BCVA refers to the measurement of the best possible vision that can be achieved following refraction. BCVA was assessed using a Snellen chart. The resultant measures were converted to Early Treatment of Diabetic Retinopathy Study ETDRS letter score. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Percentage of participants with IOP ≥20 mm Hg at 3 months
Time Frame: 3 months after injection
Intraocular pressure (IOP) is the fluid pressure inside the eye. Tonometry is the method that eye care professionals use to determine this. Tonometers in this study were calibrated to measure pressure in millimeters of mercury.
Secondary Outcomes
- Change in the BCVA(1 week, 1 month, 2 months and 3 months after injection.)
- Change in the Proportion of Participants with CST ≤ 320 μ(1 week, 1 month, 2 months and 3 months after injection.)
- Change in the CST(1 week, 1 month, 2 months and 3 months after injection.)
- Change in the Percentage of Reduction in Excess Foveal Thickness (EFT)(1 week, 1 month, 2 months and 3 months after injection.)
- Change in the Serious Treatment-Emergent Adverse Events (S-TEAEs)(1 week, 1 month, 2 months and 3 months after injection.)
- Change in the IOP(1 week, 1 month, 2 months and 3 months after injection.)