Open Label Macugen for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.
详细描述
Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current clinical practice based on randomized controlled clinical trials (ETDRS, BVOS) employs laser photocoagulation, either in a focal or grid pattern, to treat macular edema associated with diabetic retinopathy and branch retinal vein occlusion. Unfortunately, laser photocoagulation is ineffective in central retinal vein occlusion (CRVO), and no proven therapy exists for CRVO.
The pathogenesis of macular edema in retinal vascular diseases is generally accepted to be increased levels of vascular endothelial growth factor (VEGF) due to ischemic or other stimuli. VEGF is known to be one of the most potent stimulators of vascular leakage in humans. Therefore, it seems sensible to study inhibition of VEGF to reduce vascular leakage, reduce macular edema, and improve vision in these retinal vascular disorders.
Phase 2 randomized, controlled clinical trials of Macugen in diabetic macular edema and in macular edema associated with CRVO have been conducted. In the diabetes trial, patients treated with Macugen had improved vision, reduced macular edema as measured by optical coherence tomography (OCT), and reduced need for laser treatment compared to patients treated with sham injections. In the CRVO trial, patients treated with Macugen 1 mg every 6 weeks for 24 weeks had improved vision and reduced macular edema at week 30 compared to sham. This is the first randomized trial of treatment for CRVO to show a benefit over control. Based on these positive findings, we plan to study Macugen treatment of macular edema due to BRVO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age
- •Duration of BRVO macular edema less than 6 months prior to baseline visit
- •Best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4 meters testing method.
- •Central foveal thickness greater than or equal to 250 microns using the OCT-3
- •Less than 25% of foveal capillary ring disruption
- •Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal center
- •Absence of hemorrhage or lipid in the foveal center
- •Investigator comfortable deferring macular laser for 18 weeks from baseline and intravitreous steroid for 36 weeks from baseline
排除标准
- •Ocular conditions other than BRVO related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor.
- •Intraocular surgery within past 3 months
- •Significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 microns of foveal center.
- •Likelihood of evidence driven indication for peripheral photocoagulation in the next 6 months.
- •Patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination
- •Prior grid laser within 4 months of baseline or more than one prior grid laser treatment.
- •No prior intravitreous or periocular steroid injections in the study eye.
研究组 & 干预措施
Pegaptanib Sodium 0.3mg (Macugen)
Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
干预措施: pegaptanib sodium (Macugen) (Drug)
Pegaptanib Sodium 1 mg (Macugen)
Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
干预措施: pegaptanib sodium (Macugen) (Drug)
结局指标
主要结局
Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks
时间窗: 54 Weeks
次要结局
- Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield(54 Weeks)
- Safety Parameters(54 Weeks)
- Change in Central Subfield Thickness on OCT From Baseline to Week 54(54 Weeks)
- Change in Macular Volume on OCT From Baseline to Week 54(54 Weeks)
研究者
John A. Wells, III, M.D.
Principal Investigator
Palmetto Retina Center, LLC