A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 984
- 试验地点
- 340
- 主要终点
- Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
研究概览
简要总结
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
详细描述
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- •Be male or female ≥18 years of age.
- •Have type 1 or type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%.
- •Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME).
排除标准
- •Be pregnant or breastfeeding
- •History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
- •Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
- •Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
- •If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
- •Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
- •Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
研究组 & 干预措施
EYE103 Low Dose Treatment Arm
EYE103 Low Dose Treatment Arm
干预措施: EYE103 (Drug)
EYE103 High Dose Treatment Arm
EYE103 High Dose Treatment Arm
干预措施: EYE103 (Drug)
Ranibizumab Treatment Arm
Ranibizumab Treatment Arm
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
时间窗: 52 Weeks
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
时间窗: Baseline and Week 52
The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.
次要结局
- Changes in structural and visual outcomes(Duration of the study, through Week 104)
- Proportion of participants who gain ≥15 ETDRS letters in BCVA at Week 52(Up to approximately Week 52)
- Time to gaining ≥15 ETDRS letters(Up to approximately Week 52)
- Change from Baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52(Baseline and Week 52)
- Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52(Baseline and Week 52)
- Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52(Baseline and Week 52)
- Time to absence of Diabetic Macular Edema (DME)(Up to approximately Week 104)
- Proportion of participants with resolution of macular leakage on FA at Week 24(Up to approximately Week 24)
- Proportion of participants without intraretinal and subretinal fluid at the foveal center on OCT at Week 52(Up to approximately Week 52)
- Proportion of participants who gain ≥5 ETDRS letters in BCVA at Week 52(Up to approximately Week 52)
- Proportion of participants achieving 20/40 or better BCVA at Week 52(Up to approximately Week 52)
- Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)(Up to approximately 104 Weeks)
- Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)(Up to approximately 104 Weeks)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 104 Weeks)
- Time to Absence of Diabetic Macular Edema (DME)(Up to approximately Week 104)
- Time to Gaining ≥15 ETDRS letters(Up to approximately Week 52)
- Proportion of Participants with Resolution of Macular Leakage on FA at Week 24(Up to approximately Week 24)
- Proportion of Participants Without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52(Up to approximately Week 52)
- Proportion of Participants Achieving 20/40 or Better BCVA at Week 52(Up to approximately Week 52)