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
NCT06891885 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-17
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.
Conditions
Interventions
- DRUG
-
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
- DRUG
-
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
- DRUG
-
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
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-16
- Primary Completion
- 2028-10-31
- Completion
- 2032-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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