NCT07214740已完成3 期
A Phase 3B, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety of Pegcetacoplan in a Prefilled Syringe in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye
研究概览
简要总结
This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged at least 60 years and have a diagnosis of GA secondary to AMD.
- •Participants must have adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images in the study eye as determined by the retina specialist.
- •Study eye must be deemed to be indicated for IVT pegcetacoplan therapy at the discretion of the retina specialist.
- •Female participants must be women of nonchildbearing potential, defined as postmenopausal women with 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening/baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
- •Male participants must be surgically sterile or must agree to use protocol-defined highly effective methods of contraception and to refrain from donating sperm from screening through the duration of the study and for 90 days after their dose of study drug.
- •Participants must be willing and able to provide informed consent and comply with the study visit schedule and study-related procedures/requirements.
排除标准
- •Retinal atrophy secondary to a condition other than AMD, such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy, in either eye.
- •Any history or active CNV associated with AMD or any other cause, including any evidence of RPE rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography imaging as assessed by the retina specialist.
- •Presence of an active ocular disease in the study eye that, in the opinion of the investigator, compromises or confounds visual function, including but not limited to, uveitis and other macular diseases (eg, clinically significant epiretinal membrane, full thickness macular hole, or uncontrolled glaucoma/ocular hypertension); benign conditions in the opinion of the investigator, such as peripheral retina dystrophy, are not exclusionary.
- •IOP >21 mm Hg in the study eye at the screening/baseline visit.
- •Participants who have legal blindness or worse vision in study eye (ie, best-corrected visual acuity [BCVA] of ≤35 Early Treatment Diabetic Retinopathy Study letters).
- •History of laser therapy in the macular region of study eye.
- •Any intraocular surgery in the study eye at any time during the past 3 months.
- •Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period.
- •Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye.
- •Active, suspected, or history of IOI in either eye at the screening/baseline visit.
- •Any contraindication to IVT injection, including current ocular or periocular infection.
- •Current systemic infectious disease or a therapy for active infectious disease.
- •History of IVT injection in the study eye within 90 days or 5 half-lives of the product (other than IVT pegcetacoplan), whichever is longer, prior to the screening/baseline visit
- •Participation in an investigational product or medical device study (other than IVT pegcetacoplan studies) within 90 days or 5 half-lives of the product, whichever is longer, prior to the screening/baseline visit.
- •Known hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe
Experimental
This is a 30-day, phase 3b, single-arm, open-label, multicenter study to evaluate the safety of IVT pegcetacoplan administered via PFS in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study consists of a screening/baseline visit at day 1, a follow-up call at day 7, and an end of study visit at day 30.
干预措施: APL-2, Pegcetacoplan (Drug)
结局指标
主要结局
To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye
时间窗: Up to Day 30
次要结局
- The number of IVT pegcetacoplan injections successfully administered using PFS as reported by retina specialists immediately following the injection(At Day 1)
研究者
研究点 (3)
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