Study to Evaluate the Feasibility and Variability of Select Vision Assessments in Subjects with a Leber's Congenital Amaurosis (LCA) Type Phenotype - PQ-110-004

ProQR Therapeutics0 个研究点目标入组 7 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

Trial is onging in other countries

•1. Persistence of detectable outer nuclear layer (ONL) in the area of the
•macula in the opinion of the Investigator, as determined by OCT
•2. Clear ocular media and adequate pupillary dilation to permit good quality
•retinal imaging, as assessed by the Investigator
•3. An adult (* 18 years) willing and able to provide informed consent for
•participation OR a minor (6 to < 18 years) with a parent or legal guardian
•willing and able to provide written permission for the subject*s participation
•prior to performing any study related procedures and minor subjects able to
•provide age appropriate assent for study participation
•4. An adult willing to comply with the protocol, follow study instructions,
•attend study visits as required and willing and able to complete all study
•assessments, in the opinion of the Investigator OR a minor able to complete
•all study assessments and comply with the protocol and has a parent or
•caregiver willing and able to follow study instructions and attend study visits
•with the subject as required, in the opinion of the Investigator
•5. Adequate verbal communication as to allow assessment via mobility course, in
•the opinion of the Investigator
•6. Clinical diagnosis of: 1) LCA Type 10, 2) any other LCA subtype or 3) any
•subtype of inherited retinal disease, which has a phenotype representative of
•LCA Type 10, as assessed with concurrence of the Medical Monitor.

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