Efficacy and Safety of Intravitreal Ranibizumab (Lucentis®) Injection in the Treatment of Non-leaking Macular Cysts in Patients With Retinal Dystrophy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Macula
研究概览
简要总结
To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection in the treatment of non-leaking macular cysts in patients with retinal dystrophy.
Material and Methods:
Design - Prospective, nonrandomized, nonblinded, clinical trial. Participants - Patients >18 years diagnosed with retinal dystrophies and non-leaking macular cysts between Jan 2015 and July 2018 in 1 center.
Methods - Phase 1: Patients with best corrected visual acuity (BCVA) < 0.5 will receive carbonic anhydrase inhibitors (CAI) [oral acetazolamide 500mg/day or topical brinzolamide twice daily] and followed up for three months. Phase 2: Patients who do not show an adequate response with CAI will receive three 0.5mg IVR injection at monthly intervals.
Outcome - 1) Significant reduction (> 10%) of the central macular thickness (CMT), 2) Improvement (> 1 line) in BCVA 3) Presence of any complication.
详细描述
The treatment of cystoid macular edema (CME) in retinitis pigmentosa (RP) is well established in medical literature. These treatments include topical and oral carbonic anhydrase inhibitors (CAI), intravitreal triamcinolone acetonide, and laser photocoagulation. Oral acetazolamide, a carbonic anhydrase inhibitor (CAI), was found to be effective in the treatment of RP related CME with improvement in both visual acuity and fundus fluorescein angiography (FFA). However, some patients may not benefit from the treatment, or do not tolerate it, while others may develop rebound CME with prolonged use of at least 8 to 12 weeks.
An emerging treatment modality for CME in RP is the use of intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF) such as bevacizumab (Avastin®) and ranibizumab (Lucentis®). Anti-VEGF has been used successfully for treating diabetic macular edema, and macular edema secondary to retinal vein occlusion and choroidal neovascularization, with limited side effects.
A subset of patients with retinal dystrophy develop non-leaking macular cysts that can be confused with CME on ophthalmoscopy and optical coherence tomography (OCT). FFA establishes the cavitary nature of the maculopathy, with no hyperfluorescence seen on angiography compared with leakage seen in patients with CME and retinal dystrophy.
CAI may promote resolution of the non-leaking macular cysts. There are limited studies that explore the effect of anti-VEGF specifically on non-leaking macular cysts in retinal dystrophies.
Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Omani patients over 18 year old, with retinal dystrophy and non-leaking macular cysts confirmed by fundus examination, electroretinography (ERG), optical coherence tomography (OCT), fundus fluorescein angiography (FFA) and genetic testing.
- •Included patients should also have the capacity and cooperation to undergo visual function assessment (i.e. best-corrected visual acuity (BCVA), color vision as well as the above-mentioned investigations.
排除标准
- •Patients with pseudo-retinitis pigmentosa, those with cystic macular lesions or progressive retinal disease due to any cause other than retinal dystrophy, and patients with reduced visual acuity due to media opacities (e.g. cataract). Patients with any contraindication or known allergy to brinzolamide, acetazolamide or anti-VEGF agents will not receive the respective drug, nor those who underwent intraocular surgery or injection within the last 1 month.
研究组 & 干预措施
Carbonic Anhydrase Inhibitor (CAI) Arm
Patients who have received carbonic anhydrase inhibitor (CAI) therapy namely oral acetazolamide or topical brinzolamide
干预措施: Carbonic Anhydrase Inhibitor (CAI) therapy (Drug)
Intravitreal ranibizumab (IVR) arm
Intravitreal ranibizumab (IVR) injection administered to patients who have not shown adequate response or who have not tolerated CAI therapy
IVR therapy = Three 0.5mg IVR injection at monthly intervals
干预措施: Intravitreal ranibizumab (IVR) injection (Drug)
结局指标
主要结局
Macula
时间窗: 3 months
Improvement in visual acuity by over one line
Complications
时间窗: 3 months
Presence of any complications from treatment
Macular Cyst
时间窗: 3 months
Reduction in central macular thickness by 10%
次要结局
未报告次要终点