An Early Phase 1 interventional study of PUMCH-E101 Injection(High dose) in Inherited Retinal Diseases, sponsored by Peking Union Medical College Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E101 injection in the contralateral eye of subjects with RDH12 retinopathy.
This is an open-label, single-center, single-dose study. One eye of each participant will receive a single intravitreal injection of PUMCH-E101. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intraocular injection of a single high dose of PUMCH-E101
Biological: PUMCH-E101 Injection(High dose)
Single intravitreal injection
Incidence of DLTs
Number and proportion of dose limited toxicity (DLTs)
Time frame: 4 weeks
Incidence of AEs
Number and severity of overall and ocular Adverse Events (AEs)
Time frame: 52 weeks
Incidence of SAEs
Number and severity of overall and ocular Serious Adverse Events (SAEs)
Time frame: 52 weeks
Changes in best corrected visual acuity (BCVA) compared to the baseline.
Time frame: 52 weeks
Change in low-light visual acuity (LLVA) compared to baseline.
Time frame: 52 weeks
Changes in the average sensitivity (MS) of visual field compared to baseline.
Time frame: 52 weeks
Changes in scores from the Visual Function Questionnaire-25 (NEI VFQ-25) compared to baseline values.
Time frame: 52 weeks
Changes in scores from the Michigan Retinal Degeneration Questionnaire (MRDQ) compared to baseline values.
Time frame: 52w
Changes in scores from the Impact of Vision Impairment for Children (IVI-C) compared to baseline values
Time frame: 52w
Changes in the concentration of 4-hydroxynonenal (4-HNE) in the aqueous humor compared to the baseline.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Peking Union Medical College Hospital →