A Phase 2 Randomized, Dose-Masked Study of Intravitreal EYE103 in Participants With Neovascular Age-Related Macular Degeneration (NVAMD) or Macular Edema Following Branch Retinal Vein Occlusion (BRVO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 104
- 主要终点
- Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
研究概览
简要总结
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).
The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.
All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.
详细描述
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).
The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT:
- one cohort of 40 treatment naïve NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy),
- one cohort of 40 incomplete responder (IR) NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy),
- one cohort of 40 IR NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103, to be administered in combination with aflibercept 2.0 mg
- one cohort of 40 treatment naïve BRVO participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy)
Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.
All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg in the study eye on Day 1.
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
- •Key General Inclusion Criteria
- •Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- •Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria
- •Be ≥ 50 years of age
- •Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement
- •For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment
- •Key Incomplete Responder (IR) NVAMD-specific Inclusion Criteria
- •Be ≥ 50 years of age
- •Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
- •For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2
- •Key Branch Retinal Vein Occlusion (BRVO)-specific Inclusion Criteria
- •Be diagnosed with BRVO in the study eye
- •Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO
- •Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening
排除标准
- •Key General Exclusion Criteria
- •Pregnant or breastfeeding
- •History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
- •Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
- •Currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
- •Key NVAMD-specific Exclusion Criteria
- •Have had previous thermal subfoveal laser therapy in the study eye
- •Have had previous photodynamic therapy with Visudyne in the study eye
- •Key BRVO-specific Exclusion Criteria
- •Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, diabetic macular edema, NVAMD, Irvine-Gass syndrome)
- •Have active iris or angle neovascularization or neovascular glaucoma in the study eye
研究组 & 干预措施
IR NVAMD - Low Dose EYE103
Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
IR NVAMD - High Dose EYE103
Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg
Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
干预措施: Aflibercept 2.0 mg (Drug)
IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg
Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
干预措施: EYE103 (Drug)
Treatment Naïve BRVO - Low Dose EYE103
Treatment Naïve BRVO Cohort - Low Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg
Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
干预措施: Aflibercept 2.0 mg (Drug)
Treatment Naïve NVAMD - Low Dose EYE103
Treatment Naïve NVAMD Cohort - Low Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
Treatment Naïve NVAMD - High Dose EYE103
Treatment Naïve NVAMD Cohort - High Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg
Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg
干预措施: EYE103 (Drug)
Treatment Naïve BRVO - High Dose EYE103
Treatment Naïve BRVO Cohort - High Dose EYE103 (50 μL)
干预措施: EYE103 (Drug)
结局指标
主要结局
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
时间窗: Week 12
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
次要结局
- Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)(Duration of the study, through Week 12)
- Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart(Duration of the study, through Week 12)