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

GENSIGHT BIOLOGICS0 个研究点目标入组 90 人开始时间: 2021年1月29日最近更新: 2021年4月5日

试验速览

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•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:
•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

•1.Light Perception (LP) or No Light Perception (NLP) visual acuity in any eye, as defined by the study’s standard operating procedure (SOP) for visual acuity testing.
•2. Subjects taking idebenone who have not completely discontinued the idebenone at least 7 days prior to Visit 2. If the subject has not discontinued idebenone at least 7 days prior to Visit 2, Visit 2 may be delayed until the 7-day period is complete as long as the study visit windows are adhered to.
•3.Presence of active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
•4.Presence of alcoholism, alcohol dependence, or alcohol or drug abuse (excluding nicotine).
•5.Presence of systemic illness or medically significant abnormal laboratory values that are deemed by the Investigator to preclude the subject’s safe participation in the study.
•6.Any medical or psychological condition that, in the opinion of the Investigator, may lead to non-tolerance of the treatment regimen, may compromise the safe participation of the subject in the study or would preclude compliance with the study protocol or ability of the subject to successfully complete the study.
•7. Any non-selection criteria which may have appeared after the screening visit

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