Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of participants with BCVA gain≥ 15 Letters at 3 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
4 mg Triamcinolone Acetonide (TA)/ Suprachoriodal Injection
Suprachoroidal injection of 4 mg in 100 μL of TA was administered as a single injection.
干预措施: suprachoroidal injection of Triamcinolone Acetonide. (Drug)
结局指标
主要结局
Percentage of participants with BCVA gain≥ 15 Letters at 3 months
时间窗: 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
时间窗: 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.
次要结局
- 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.)