Safety and Efficacy Study of PUMCH-E111 Injection in Subjects With RLBP1 Related Inherited Retinal Dystrophy

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPeking Union Medical College Hospital

About this trial

The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E111 injection in subjects with RLBP1 related Inherited Retinal Dystrophy.

Eligibility criteria

Qualifiers

Subjects voluntarily participate and sign the informed consent form;

Age between 18-55 years old, gender is not limited;

Clinical diagnosis of IRD caused by RLBP1 mutations;

For the study eye, residual visual field within the 30° central field is tested using Program G or Program LVC on the Octopus perimeter;

Disqualifiers

Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;

Presence of diabetic retinopathy, retinal vein occlusion, pathological myopia, retinal detachment, or other conditions in the study eye that are assessed by the investigator as affecting the safety of the subject or the validity of the study;

Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;

History of vitreous hemorrhage in the study eye within 6 months prior to screening;

Trial design

Treatments tested in this trial

  • PUMCH-E111 Injection(Low dose)
  • PUMCH-E111 Injection(High dose)

Treatment groups

6 Participants
are divided into 2 treatment groups