EUCTR2020-002931-32-DE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6月2日最近更新:
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.
- •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. Participants 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 participants 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 participants must be:
- •a. Women of nonchildbearing potential, or
- •b. Women of childbearing potential (WOCBP) defined as any women who have experienced menarche and who are not permanently sterile or
- •postmenopausal, must have 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.
- •Inclusion criterion #2 applies to the fellow eye.
- •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. Participants 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.
- •Exclusion criteria 2 and 3 apply to the fellow eye.
研究者
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