Actively Recruiting
A Study of DSP-3077 Subretinal Injection Safety and Tolerability in Adults with Retinitis Pigmentosa
Led by Sumitomo Pharma America, Inc. · Updated on 2026-04-17
12
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and clinical responses after a single dose of DSP-3077 in adults with retinitis pigmentosa (RP). This Phase 1/2a, open-label, single-arm study involves three groups defined by their visual acuity and dose level of DSP-3077. The study aims to assess safety, engraftment, and potential therapeutic effects of DSP-3077 retinal sheets delivered subretinally. Participants will receive a single subretinal injection of DSP-3077 in one eye, with two dose levels tested across three cohorts. Each cohort will have 4 participants, totaling 12 adults. Cohorts 1 and 2 receive lower and higher doses respectively, while cohort 3 involves participants with better visual acuity receiving a high dose. The treatment uses a specialized delivery device for the injection. The study lasts about 67 months, starting with a 2-week period of frequent visits post-surgery, then monthly visits until month 4, followed by visits every 3 months up to month 24, and every 6 months up to month 60. Long-term safety data will be collected annually from years 6 to 15 after treatment. Researchers will monitor ocular adverse events, serious adverse events, and treatment tolerability throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older at the time of informed consent.
- Participant has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
- Participant is willing to consent to genetic testing if not already completed.
- For Cohorts 1 and 2: Study eye vision between hand motion and 20 ETDRS letter score (up to 20/400 Snellen equivalent) at Screening and Baseline.
- For Cohort 3: Study eye vision between 20 and 35 ETDRS letter score (approximately 20/400 to 20/200 Snellen equivalent) at Screening.
- Participant is in good physical health based on medical history, physical exam, vital signs, ECG, and lab tests at Screening.
You will not qualify if you...
- Presence of any eye disease or visual disorder other than retinitis pigmentosa that impairs visual function (e.g., retinal vascular disease, glaucoma).
- Any other eye condition such as ocular media opacity or nystagmus that would affect evaluation or surgical delivery.
- Any clinically significant unstable medical condition or chronic disease limiting study participation.
- Female participants who are pregnant, lactating, or planning pregnancy.
- Prior treatment with nonapproved, experimental, or investigational therapies in either eye within 90 days or 5 half-lives before Screening.
- Previous cell therapy, gene augmentation therapy, genome editing therapy, or subretinal therapy for an eye disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Multiple visits during screening period
Duration - Day 1
Participants receive a single subretinal injection of DSP-3077 in one eye to evaluate safety and tolerability of two dose levels.
1 treatment visit (in-person)
Duration - Approximately 60 months
Participants have frequent visits for 2 weeks after surgery, then monthly visits through Month 4, followed by visits every 3 months through Month 24, and every 6 months through Month 60 to monitor safety and therapeutic response.
Frequent visits for 2 weeks, monthly visits through Month 4, then visits every 3 months through Month 24, and every 6 months through Month 60
Duration - 9 years
Participants are followed annually from 6 years to 15 years after treatment to further characterize long-term safety of DSP-3077.
Annual visits from Year 6 through Year 15
Trial Site Locations
Total: 2 locations
1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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