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DSP-3077 for Retinitis Pigmentosa Safety Study

This study is looking into the safety of DSP-3077, a new treatment for Retinitis Pigmentosa (RP). RP is an eye disease that causes vision loss. Researchers want to see how well people tolerate DSP-3077 and if it causes any side effects. You might be able to join if you are 18 or older and have a diagnosis of non-syndromic RP. The study will give a single injection of DSP-3077 into one eye, using different dose levels. The main goal is to track any eye-related side effects over 60 months. This study will enroll 12 participants.

Study design
This is a Phase 1/2a, open-label, single-arm study with 12 participants divided into 3 groups, each receiving a different dose of DSP-3077.
What's involved
You would have frequent visits for the first two weeks after surgery, then monthly for a few months, and less often for the next 60 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 67 months, with long-term data collected annually for up to 15 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06891885

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
PHASE1Ages 18+InterventionalTreatment
Sumitomo Pharma America, Inc.
~12 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:DSP-3077 Retinal Sheet Cohort 1DSP-3077 Retinal Sheet Cohort 2DSP-3077 Retinal Sheet Cohort 3

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of ocular adverse events (AEs)
Measured over 60 months
+6 more outcomes measured

Conditions

Retinitis Pigmentosa

Explore related trials

Retinitis Pigmentosa

NCT06891885

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts Eye and Ear

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Albert Cheng
[email protected]
617-573-6060
Email the study team

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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.

What this trial measures

  • Incidence of ocular adverse events (AEs)60 months
  • Incidence of ocular serious adverse events (SAEs)60 months
  • Incidence of ocular adverse events (AEs) leading to discontinuation60 months
  • Incidence of adverse events (AEs)60 months
  • Incidence of serious adverse events (SAEs)60 months
  • Incidence of adverse events (AEs) leading to discontinuation60 months
  • Incidence of adverse events (AEs) leading to death60 months