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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT06891885
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Retinitis Pigmentosa

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DSP-3077 Retinal Sheet Cohort 1 — DRUG
    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 — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Apr 16, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Best Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline
  • Experimental: Cohort 2
    Best Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline
  • Experimental: Cohort 3
    Best Corrected Visual Acuity (BCVA) in the study eye between 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≥ 20/400 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent), inclusive at Screening; BCVA in the study eye between 10 ETDRS letter score (approximately ≥ 20/640 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent) at Baseline

Primary Outcome Measure

Incidence of ocular adverse events (AEs) [ Time Frame: 60 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Albert Cheng
[email protected]
617-573-6060
University of MinnesotaMinneapolisMinnesota55455
Jacob Stauffer
[email protected]
612-625-4108

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By research site
Massachusetts Eye and Ear· Boston, MAUniversity of Minnesota· Minneapolis, MN

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