A Randomized, Controlled Study of the Safety and Efficacy of Squalamine Lactate Eye Drops in Combination With Ranibizumab in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
研究概览
简要总结
A randomized, controlled study of the safety and efficacy of Squalamine Lactate Eye Drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. The study duration is 52 weeks and patients will be randomized to one of four treatment arms.
详细描述
A randomized, controlled study of the safety and efficacy of Squalamine Lactate eye drops in combination with Ranibizumab intravitreal injections in patients with diabetic macular edema. Subjects will be randomized to one of the following treatment arms:
- Squalamine Lactate Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered twice a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Squalamine Lactate Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injections of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
- Vehicle Ophthalmic Solution administered four times a day for 52 weeks in combination with monthly injection of ranibizumab from baseline through week 20 and ranibizumab as needed from week 24 through week 52.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects will have clinically significant diabetic macular edema of ≥ 300 microns with central involvement using the Heidelberg or Cirrus machine
- •Best corrected visual acuity of 20/32 to 20/320 inclusive in the study eye
- •Adults ≥ 18 years of age with type 1 or 2 diabetes mellitus with diabetic macular edema
排除标准
- •History of vitreoretinal surgery in the study eye
- •Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
- •Any prior laser in study eye
- •Previous use of intraocular or periocular corticosteroids in the study eye within 6 months of screening
- •Previous treatment with anti-angiogenic drugs in either eye within 3 months of screening
- •Uncontrolled diabetes mellitus with HbA1c levels greater than 12
- •Ocular disorders in the study eye, other than diabetic macular edema, that my confound interpretation of study results
研究组 & 干预措施
Squalamine Solution BID 0.2%
Squalamine Lactate Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52
干预措施: Squalamine Lactate Ophthalmic Solution 0.2% (Drug)
Vehicle Solution 0.2% BID
Vehicle Ophthalmic Solution 0.2% administered twice a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52
干预措施: Squalamine Lactate Ophthalmic Solution 0.2% (Drug)
Squalamine Solution 0.2% QID
Squalamine Lactate Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranibizumab as needed from week 24 through week 52
干预措施: Squalamine Lactate Ophthalmic Solution 0.2% (Drug)
Vehicle Solution 0.2% QID
Vehicle Ophthalmic Solution 0.2% administered four times a day for 52 weeks in combination with monthly intravitreal injections of ranibizumab 0.3mg from baseline through week 20 and ranbizumab as needed from week 24 through week 52
干预措施: Squalamine Lactate Ophthalmic Solution 0.2% (Drug)
结局指标
主要结局
To explore the effect of Squalamine Lactate eye drops on Best Corrected Visual Acuity in subjects with diabetic macular edema
时间窗: Mean change from baseline to Week 24
Proportion of patients gaining at least 3,4 and 5 lines in best corrected visual acuity from baseline to week 24
次要结局
- To assess need for rescue injections of Ranibizumab 0.3mg(Week 24 through week 52)
- To assess the safety and tolerability of Squalamine Eye Drops, measured by ophthalmic examination, the recording and evaluation of clinical AEs(At week 24 and at Week 52)
- To assess the change in Central Retinal Thickness(Change at week 24 and at week 52)
研究者
Starr Muscle
MD, primary investigator
Prism Vision Group