Actively Recruiting
Safety and Tolerability Study of DSP-3077 Retinal Sheet Injection in Adults with Retinitis Pigmentosa An Open-label, Dose-Escalation Trial
Led by Sumitomo Pharma America, Inc. · Updated on 2026-04-17
12
Participants Needed
2
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and clinical responses of DSP-3077, an induced pluripotent stem cell-derived retinal sheet, in adults with retinitis pigmentosa (RP). This Phase 1/2a, open-label, single-arm, dose-escalation trial enrolls male and female participants aged 18 years or older with nonsyndromic RP. The study aims to assess the safety and potential therapeutic effects of two dose levels of DSP-3077 delivered by a specialized device. Participants are assigned to one of three cohorts based on visual acuity and dose level. Each cohort includes four participants who receive a single subretinal injection of DSP-3077 in one eye on Day 1. Cohort 1 receives a low dose, while Cohorts 2 and 3 receive higher doses. The study involves monitoring the delivery device's performance and the engraftment of DSP-3077. After screening, participants undergo an initial two-week period of frequent visits following surgery, then monthly visits until Month 4, quarterly visits until Month 24, and semi-annual visits through Month 60. Safety is closely monitored by recording ocular and systemic adverse events. Following Month 60, long-term safety data will be collected annually for up to 15 years. The total participation duration is about 67 months, covering screening through extended observation.
CONDITIONS
Official 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
- Clinical diagnosis of nonsyndromic retinitis pigmentosa
- Willing to consent to genetic testing if not previously done
- For Cohorts 1 and 2: Best corrected visual acuity (BCVA) in study eye between hand motion and 20 ETDRS letter score (approximately 20/400 Snellen equivalent), inclusive
- For Cohort 3: BCVA in study eye between 20 and 35 ETDRS letter score (approximately 20/400 to 20/200 Snellen equivalent), inclusive
- In good physical health based on medical history, physical exam, vital signs, ECG, and lab tests at screening
You will not qualify if you...
- Eye disease or visual disorder other than retinitis pigmentosa that impairs vision (e.g., retinal vascular disease, glaucoma)
- Any other eye condition that would interfere with accurate evaluation or surgical delivery (e.g., ocular media opacity, nystagmus)
- Clinically significant unstable medical condition or chronic disease limiting study participation
- Female who is pregnant, lactating, or planning pregnancy
- Received any nonapproved, experimental, or investigational eye treatment within 90 days or 5 half-lives before screening
- Previously received cell therapy, gene augmentation, genome editing, or subretinal therapy for an eye disease
AI-Screening
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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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