EUCTR2017-002187-40-GB进行中（未招募）1 期
Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year - REFLECT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
入选标准
- •1. Age 15 years or older on the date of signed informed consent.
- •2. Clinically manifested vision loss due to ND4 LHON, to any extent, in at
- •least one eye.
- •3. Vision loss duration of = 365 days (i.e. = 1 year) in each affected eye
- •at Inclusion Visit
- •(Visit 2).
- •4. Female subjects (if of childbearing potential) must agree to use
- •effective methods of birth control for up to 6 months after Treatment Visit(s) 3 and male subjects must agree to use condoms for up to 6 months after Treatment Visit(s) 3.
- •5. Ability to obtain adequate pupillary dilation to permit thorough ocular
- •examination and visual testing.
- •6. Subject – and parent/legal guardian if the subject is under 18 years of
- •age – has provided signed, written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Any known allergy or hypersensitivity to GS010 or its constituents.
- •2. Contraindication to intravitreal injection in any eye.
- •3. Intravitreal drug delivery to any eye within 30 days prior to the
- •Screening Visit (Visit 1).
- •4. Previous vitrectomy in either eye.
- •5. Narrow angle in any eye contra-indicating pupillary dilation.
- •6. Presence of disorders or diseases of the eye or adnexa, excluding
- •LHON, which may interfere with visual or ocular assessments, including SD-OCT, during the study period.
- •7. Presence of known/documented mutations, other than the G11778A
- •ND4 LHON-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system.
- •8. Presence of systemic or ocular/vision diseases, disorders or
- •pathologies, other than LHON, known to cause or be associated with vision loss, or whose associated treatment(s) or
- •therapy(ies) is/are known to cause or be associated with vision loss.
- •9. Presence of optic neuropathy from any cause except LHON.
- •10. Presence of illness or disease that, in the opinion of the Investigator,
- •include symptoms and/or the associated treatments that can alter visual function, for instance cancers or pathology of the central nervous system, including Multiple Sclerosis (diagnosis of Multiple Sclerosis must be based on the 2010 Revisions to the McDonald Criteria [Polman 2011]).
- •11. History of recurrent uveitis (idiopathic or immune-related) or active
- •ocular inflammation.
- •12. Participation in another clinical trial and receiving an IMP within 90 days prior to the Screening Visit (Visit 1). Exception: subjects remain eligible if they completed a clinical trial with idebenone as an IMP less than 90 days prior to Visit 1 AND completely discontinued idebenone at least 7 days prior to Visit 2.
- •13. Previous treatment with ocular gene therapy in either eye.
- •14. Subjects refusing to discontinue idebenone.
- •15. Subjects who have undergone ocular surgery of clinical relevance
- •(per Investigator assessment) within 90 days preceding the Screening
- •Visit (Visit 1).
- •16. Female Subjects who are, or who intend to breast feed during the initial six months' postadministration of GS010.
- •17. Subjects who unable to tolerate (e.g. the immune modulating
- •regimen) or unable or unwilling to comply with all the protocol
- •requirements.
研究者
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