A Randomized, Double-Masked, Multicenter Phase 2 Study Evaluating the Efficacy, Safety, and Tolerability of Oral BGE-102 as Mono- and Combination Therapy in Participants With Center-Involved Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME). BGE-102 decreases inflammation which may improve vision or slow the progression of vison loss in those with CI-DME. Participants will be randomized to one of 3 arms and receive either BGE-102 in combination with an anti-vascular endothelial growth factor (anti-VEGF) drug, BGE-102 in combination with sham injection, or BGE-102 placebo in combination with an anti-VEGF drug. This study will also evaluate safety and tolerability of BGE-102.
详细描述
The purpose of this study is to assess the efficacy and safety of oral once a day (QD) dosing of BGE-102 alone or BGE-102 in combination with an anti-VEGF drug compared to anti-VEGF alone in participants with CI-DME on ocular parameters over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (up to 4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given active, once daily capsules, or placebo, once daily capsules, in combination with anti-VEGF every four weeks intravitreal injection or sham injection for the entire 12-week treatment period.
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, Investigator, Outcomes Assessor)
盲法说明
The injecting clinician is unmasked
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-75 years of age
- •Type 1 or Type 2 Diabetes diagnosis
- •Diabetic Macular Edema (DME) affecting the center of vision
- •Study Eye may be treatment naïve (never received treatment) or previously treated and if previously treated, meets washout requirements
- •Acceptable Vision as measured by an eye chart
- •Visual Acuity and retinal thickness as measured by an eye scan, results meeting eligibility criteria
- •Willing to use birth control, if applicable
排除标准
- •Significant ocular disease, condition, or prior ocular treatment and/ or procedure that could affect vision, study assessments, or participant safety, including failure to meet required treatment washout periods
- •Macular edema in the study eye due to causes other than DME, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration
- •Significant macular ischemia in the study eye that would limit visual improvement as assessed by the Investigator and confirmed by the Reading Center
- •Uncontrolled diabetes
- •Uncontrolled blood pressure
- •Medically unstable cardiac conditions and/or medically important ECG abnormalities.
- •Relevant medical or psychiatric condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
- •Women who are pregnant or nursing
研究组 & 干预措施
Arm A: BGE-102 Monotherapy
BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks
干预措施: Oral BGE-102 (Drug)
Arm A: BGE-102 Monotherapy
BGE-102 Capsules dosed once daily in combination with Sham intravitreal injection delivered every 4 weeks
干预措施: Sham (Other)
Arm B: BGE-102 and anti-VEGF Combination Therapy
BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks
干预措施: Oral BGE-102 (Drug)
Arm B: BGE-102 and anti-VEGF Combination Therapy
BGE-102 Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks
干预措施: Anti-VEGF (Drug)
Arm C: anti-VEGF Monotherapy
Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks
干预措施: Oral Placebo Matching BGE-102 (Drug)
Arm C: anti-VEGF Monotherapy
Placebo Capsules dosed once daily in combination with anti-VEGF intravitreal injection delivered every 4 weeks
干预措施: Anti-VEGF (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA)
时间窗: Week 12
Change from Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) in the Study Eye
次要结局
- Incidence of serious adverse events (SAEs)(Up to Week 16)
- Incidence of treatment-emergent adverse events (TEAEs)(Up to Week 16)