ISRCTN14152148进行中（未招募）1 期
A Phase I, multicenter, open-label study of the safety, tolerability, pharmacokinetics, and immunogenicity of intravitreal injections of RO7446603 alone and co-administered with aflibercept or faricimab in patients with diabetic macular edema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years at the time of signing the Informed Consent Form
- •2. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- •3. Macular thickening secondary to DME involving the center of the fovea
- •4. Decreased visual acuity attributable primarily to DME
排除标准
- •Current exclusion criteria as of 08/08/2023:
- •1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- •2. Uncontrolled blood pressure (BP), defined as systolic >180 millimetres of mercury (mmHg) and /or diastolic >100 mmHg while the participants is at rest
- •3. Pregnancy or breastfeeding, or intention to become pregnant during the study
- •4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1
- •5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1
- •6. High-risk proliferative diabetic retinopathy (PDR) in the study eye
- •7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
- •8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
- •9. Other protocol-specified inclusion/exclusion criteria may apply
- •Previous exclusion criteria:
- •1. Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- •2. Uncontrolled blood pressure (BP), defined as systolic >180 mmHg and/or diastolic >100 mmHg while the participants is at rest
- •3. Pregnancy or breastfeeding, or intention to become pregnant during the study
- •4. Participants with ITV anti-VEGF treatment within 3 months prior to Day 1
- •5. Participants with any ITV or periocular (subtenon) corticosteroid treatment within 6 months prior to Day 1
- •6. High-risk proliferative diabetic retinopathy (PDR) in the study eye
- •7. Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
- •8. Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye
- •9. Other protocol-specified inclusion/exclusion criteria may apply
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