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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
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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
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2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
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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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