Evaluation of long-term safety and efficacy after neuroprotective gene therapy with SIV-hPEDF for retinitis pigmentosa

Evaluation of long-term safety and efficacy after neuroprotective gene therapy with SIV-hPEDF for retinitis pigmentosa - Long-term safety and efficacy after SIV-hPEDF gene therapy for retinitis pigmentosa

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049825

Enrollment

Registered

2023-01-04

Start date

2020-11-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with retinitis pigmentosa who received DVC1-0401 in the "Phase I/IIa Investigator-Initiated Trial of Neuroprotective Gene Therapy for Retinitis Pigmentosa by Subretinal Administration of DVC1-0401"

Exclusion criteria

Exclusion criteria: Patients whom the investigator determines are not appropriate as research subjects

Design outcomes

Primary

Measure	Time frame
Rate of change in visual acuity (logMAR equivalent)	—

Secondary

Measure	Time frame
1. Rate of change in mean retinal sensitivity at the 12 center points in HFA10-2 static perimetry tests 2. Rate of change in mean retinal sensitivity at the 4 center points in HFA10-2 static perimetry tests 3. Percentage of serious adverse events for which a causal relationship with DVC1-0401 cannot be ruled out	—

Countries

Japan

Contacts

Public ContactYusuke Murakami

Kyushu University Hospital Department of Ophthalmology

murakami.yusuke.407@m.kyushu-u.ac.jp+81-92-642-5648

Outcome results