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Retinitis PigmentosaPhase 1/2NCT06891885

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

A Phase 1/2 study testing DSP-3077 Retinal Sheet Cohort 1, DSP-3077 Retinal Sheet Cohort 2 and DSP-3077 Retinal Sheet Cohort 3 in people with Retinitis Pigmentosa, run by Sumitomo Pharma America, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 defined by visual acuity (VA) criteria and dose level of DSP-3077. Each cohort will include 4 participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
DSP-3077 Retinal Sheet Cohort 1, DSP-3077 Retinal Sheet Cohort 2 and DSP-3077 Retinal Sheet Cohort 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
16 Apr 2026to 31 Oct 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114

    Albert Cheng, 617-573-6060, acheng18@meei.harvard.edu

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Jacob Stauffer, 612-625-4108, jstauffe@umn.edu

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Open-label, Single-arm, Dose-escalation Study of the Safety and Tolerability of a Single Subretinal Uniocular Injection of Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Retinal Sheets (DSP-3077) in Adults With Retinitis Pigmentosa (RP)

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.

Read the 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 injection in adults with RP. The total duration of participant participation will be approximately 67 months from start of Screening through end of Extension Observation Period Part B. After an initial 2-week period of frequent visits after surgery, the visit frequency will be approximately monthly through Month 4, every 3 months through Month 24, and every 6 months through Month 60. After completion of Study DE101101 (Month 60 Visit or ET Visit) and under a separate process, the Sponsor will collect long-term data following treatment with DSP-3077, annually from 6 years to 15 years after DSP-3077 administration to further characterize the long-term safety of DSP-3077.

Participants will be treated in 3 cohorts, with each cohort defined by visual acuity (VA) criteria and dose level of DSP-3077. Each cohort will include 4 participants for a total of 12 participants.

Primary objective is to evaluate the safety and tolerability of 2 dose levels of DSP-3077 in adults with RP. Other objectives are to evaluate the safety, engraftment, and potential therapeutic response of 2 dose levels of DSP-3077 in adults with RP and to evaluate DSP-3077-delivery device performance.

Being tested
DSP-3077 Retinal Sheet Cohort 1, DSP-3077 Retinal Sheet Cohort 2, DSP-3077 Retinal Sheet Cohort 3
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSP-3077 Retinal Sheet Cohort 1Drug

    Also called Cohort 1

    For each participant only 1 eye will receive a low dose (>= 0.8 to < 2.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1

  • DSP-3077 Retinal Sheet Cohort 2Drug

    Also called Cohort 2

    For each participant only 1 eye will receive a high dose (>= 2.4 to < 6.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1

  • DSP-3077 Retinal Sheet Cohort 3Drug

    Also called Cohort 3

    For each participant only 1 eye will receive a high dose (>= 2.4 to < 6.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1

Study groups in NCT06891885
Study groupRoleWhat they receive
Cohort 1ExperimentalBest Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline
Receives: Drug: DSP-3077 Retinal Sheet Cohort 1
Cohort 2ExperimentalBest Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline
Receives: Drug: DSP-3077 Retinal Sheet Cohort 2
Cohort 3ExperimentalBest Corrected Visual Acuity (BCVA) in the study eye between 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≥ 20/400 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent), inclusive at Screening; BCVA in the study eye between 10 ETDRS letter score (approximately ≥ 20/640 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent) at Baseline
Receives: Drug: DSP-3077 Retinal Sheet Cohort 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ocular adverse events (AEs)

    Measured: 60 months

  2. Incidence of ocular serious adverse events (SAEs)

    Measured: 60 months

  3. Incidence of ocular adverse events (AEs) leading to discontinuation

    Measured: 60 months

  4. Incidence of adverse events (AEs)

    Measured: 60 months

  5. Incidence of serious adverse events (SAEs)

    Measured: 60 months

  6. Incidence of adverse events (AEs) leading to discontinuation

    Measured: 60 months

  7. Incidence of adverse events (AEs) leading to death

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start16 Apr 2026 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891885
Sponsor's protocol ID
DE101101
Status last verified
Apr 2026
First submitted
27 Feb 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DSP-3077 Retinal Sheet Cohort 1, DSP-3077 Retinal Sheet Cohort 2 and DSP-3077 Retinal Sheet Cohort 3 in people with Retinitis Pigmentosa, run by Sumitomo Pharma America, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ocular adverse events (AEs) (time frame: 60 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06891885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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