A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years of Age or Older With Retinitis Pigmentosa
Condition(s) studied
Investigational drug(s) / intervention(s)
DSP-3077 Retinal Sheet Cohort 1: For each participant only 1 eye will receive a low dose (\>= 0.8 to \< 2.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1
DSP-3077 Retinal Sheet Cohort 2: For each participant only 1 eye will receive a high dose (\>= 2.4 to \< 6.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1
DSP-3077 Retinal Sheet Cohort 3: For each participant only 1 eye will receive a high dose (\>= 2.4 to \< 6.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1
Study summary
The Goal of this study is to evaluate the safety, tolerability, and clinical responses following single dose of DSP-3077. Study enrolls both male and female patients in 3 cohorts with each cohort defined by visual acuity (VA) criteria and dose level of DSP-3077. Each cohort will include 4 participants.
Eligibility
Primary outcome measure(s)
- Incidence of ocular adverse events (AEs) — 60 months
- Incidence of ocular serious adverse events (SAEs) — 60 months
- Incidence of ocular adverse events (AEs) leading to discontinuation — 60 months
- Incidence of adverse events (AEs) — 60 months
- Incidence of serious adverse events (SAEs) — 60 months
- Incidence of adverse events (AEs) leading to discontinuation — 60 months
- Incidence of adverse events (AEs) leading to death — 60 months
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts Eye and Ear | Boston | Massachusetts | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
More Sumitomo Pharma America, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06891885 on ClinicalTrials.gov ↗ ← All trials in the USA