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

Recruiting now · Phase 1/Phase 2

Conditions studied: Retinitis Pigmentosa

In brief

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 facts

Study ID

NCT06891885

Run by

Sumitomo Pharma America, Inc.

People needed

12

Starts

2026-04-16

Expected to finish

2032-10-31

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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