EUCTR2020-002931-32-PL进行中（未招募）1 期
A Phase 3 open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan in subjects with geographic atrophy secondary to age-related macular degeneration
Apellis Pharmaceuticals Inc.0 个研究点目标入组 1,200 人开始时间: 2021年7月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Ocular-specific inclusion criteria apply to the study eye only.
- •1. Participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of
- •either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). Specifically, for the APL2-303 and APL2-304 studies, the following criterion also applies:
- •a. Subjects who did not permanently discontinue treatment but missed the Month 24 visit are also eligible to participate in this extension study; however, to be eligible,
- •these subjects must be screened within 60 days from the last day of the expected
- •Month 24 visit window for the antecedent study.
- •2. Clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection
- •of good quality images as determined by the investigator.
- •3. Female subjects must be:
- •a. Women of nonchildbearing potential, or
- •b. Women of childbearing potential (WOCBP) with a negative serum pregnancy test at
- •screening and must agree to use protocol defined methods of contraception for the
- •duration of the study and 90 days after their last dose of pegcetacoplan, and refrain
- •from breastfeeding for the duration of the study.
- •4. Males with female partners of childbearing potential must agree to use protocol defined
- •methods of contraception and agree to refrain from donating sperm for the duration of the
- •study and for 90 days after their last dose of pegcetacoplan.
- •5. Willing and able to give informed consent and to comply with the study procedures and assessments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1160
排除标准
- •Ocular-specific exclusion criteria apply to the study eye only.
- •1. Subjects who permanently discontinued the study drug prior to Month 24 in the APL2-304 or APL2-304 studies and only for safety assessments. Temporary pause of the study drug is not exclusionary.
- •2. Presence of an active ocular disease that, in the opinion of the investigator, compromises
- •or confounds visual function, including, but not limited to, macular hole or other macular
- •diseases (eg, clinically significant epiretinal membrane). Benign conditions in the opinion
- •of the investigator such as peripheral retinal dystrophy are not exclusionary.
- •3. Any contraindication to IVT injection including current ocular or periocular infection.
- •4. Medical or psychiatric condition that, in the opinion of the investigator, is clinically
- •significant and not suitable for study participation or make consistent follow-up over the 36-month treatment period unlikely.
- •5. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to
- •pegcetacoplan or any of the excipients in pegcetacoplan solution.
- •6. Pregnancy, breastfeeding, or positive pregnancy test.
研究者
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