Status:
RECRUITING
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
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 defi...
Detailed Description
This is a Phase 1/2a, open-label, single-arm, uncontrolled, dose-escalation study evaluating 2 dose levels of iPSC-derived retinal sheets (DSP-3077) administered with a single subretinal uniocular inj...
Eligibility Criteria
Inclusion
- Participant is \>= 18 years of age at the time of signing the informed consent.
- Participant has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
- Participant is willing to consent to genetic testing, if not already done.
- Cohorts 1 and 2: Participant will have BCVA in the study eye between hand motion and 20 ETDRS letter score (approximately \<= 20/400 Snellen equivalent), inclusive at Screening and Baseline.
- Cohort 3: Participant will have BCVA in the study eye between 20 ETDRS letter score (approximately \>= 20/400 Snellen equivalent) and 35 ETDRS letter score (approximately \<= 20/200 Snellen equivalent), inclusive at Screening.
- Participant is in good physical health, based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests at Screening.
Exclusion
- Participant has an eye disease or visual disorder other than RP that impairs visual function (eg, retinal vascular disease, glaucoma).
- Participant has any other eye condition (eg, ocular media opacity, nystagmus), which in the opinion of the investigator, would preclude an accurate evaluation at any time during the study and/or make surgical delivery more challenging.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the participant's ability to complete and/or participate in the study.
- Female participant who is pregnant or lactating or planning to become pregnant.
- Participant has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and/or received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening.
- Participant has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2032
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06891885
Start Date
October 23 2025
End Date
October 31 2032
Last Update
September 23 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114