A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist (PF-04634817) With That Of Ranibizumab In Adult Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 199
- 试验地点
- 63
- 主要终点
- Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.
详细描述
Study recruitment was stopped on April 9, 2015. This decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. This decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.
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
- •Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye
- •Reduced visual acuity resulting from retinal thickening
- •Female subjects of non-childbearing potential ≥18 years and male subjects greater than or equal to 18 years. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- •Female subjects who are not of childbearing potential must meet at least one of the following criteria:
- •Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •Have medically confirmed ovarian failure; or
- •Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females.
排除标准
- •Severe Impaired Renal Function
- •Any intraocular condition or previous surgery in either eye that would likely require medical or surgical intervention during the study duration or if allowed to progress untreated for the 16 weeks of study duration, would likely contribute to a reduction in visual acuity.
研究组 & 干预措施
Arm 1
Intravitreal administration of ranibizumab (either 0.3 or 0.5 mg, given monthly, as detailed in the prescribing information and label content approved for the country governing the study site) plus an oral placebo.
干预措施: Ranibizumab (Drug)
Arm 1
Intravitreal administration of ranibizumab (either 0.3 or 0.5 mg, given monthly, as detailed in the prescribing information and label content approved for the country governing the study site) plus an oral placebo.
干预措施: Placebo (Drug)
Arm 2
Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
干预措施: PF-04634817 (Drug)
Arm 2
Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
干预措施: Masked Sham Therapy (Drug)
结局指标
主要结局
Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)
时间窗: Baseline (Day 0) and Week 12
Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).
次要结局
- Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12(Baseline (Day 0) and Week 12)
- Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12(Baseline (Day 0) and Week 12)
- Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12(Baseline (Day 0) and Week 12)
- Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12(Baseline (Day 0) and Week 12)
- Plasma Concentration of PF-04634817 up to Week 12(Week 0, Week 4, Week 8, and Week 12)