EUCTR2017-004783-35-IT进行中（未招募）1 期
A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt Disease - A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subj
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Ophthalmic Inclusion Criteria
- •The following inclusion criteria apply to the study eye:
- •- At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory.
- •- Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive.
- •- Presence of at least one identifiable location of at least 250 micrometers contiguous width of ellipsoid zone loss on SD-OCT within the total 9 ETDRS subfields.
- •- The total area of thinned layer(s) on OCT not extending beyond the outer ring of the total 9 ETDRS subfields (e.g. not extending beyond fields 5-9).
- •- Fundus autofluorescence may show heterogeneous signals (areas of increased and/or decreased autofluorescence) but no area of subfoveal definitely decreased autofluorescence (DDAF).
- •- Clear ocular media and adequate pupillary dilatation in both eyes (OU) to allow for all imaging procedures, including good quality stereoscopic fundus photography, fundus autofluorescence, and spectral domain ocular coherence tomography.
- •- Intraocular pressure of 21 mmHg or less in the study eye.
- •General Inclusion Criteria
- •- Subjects of either gender aged between 18 and 50 years, inclusive.
- •- Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 90 days following the last dose of test medication. Male subjects should use a condom during the time of study drug exposure and for 90 days following last exposure of study drug.
- •- Provide written informed consent.
- •- Ability to return for all trial visits.
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Macular atrophy secondary to any condition other than STGD1 in either eye (e.g., drug-induced). - Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye. - Participation in an interventional study of a vitamin A derivative = 3 months prior to screening. - Any ocular condition in the study eye that would progress during the course of the study that could affect central vision, microperimetry testing or otherwise be a confounding factor. - Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve.
- •- Presence of intraocular inflammation (= trace cell or flare), macular hole, pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria). - Presence or history of idiopathic or autoimmune-associated uveitis in either eye. - Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye during the study. - Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication. - Any ocular or periocular infection or ocular surface inflammation in the past 12 weeks. - History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- •For the General Exclusion Criteria see the protocol.
研究者
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