Recruiting

iPSC-derived Retinal Sheets for Retinitis Pigmentosa

What is being tested

DSP-3077 Retinal Sheet Cohort 1

+ DSP-3077 Retinal Sheet Cohort 2

+ DSP-3077 Retinal Sheet Cohort 3

Drug

Who is being recruted

Eye Diseases+5

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Retinal Degeneration

Over 18 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorSumitomo Pharma America, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 23, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on assessing the safety and comfort of a new treatment using retinal sheets derived from induced pluripotent stem cells, called DSP-3077, for adults suffering from Retinitis Pigmentosa (RP). RP is a genetic condition that causes vision loss over time. The study involves administering these retinal sheets through a single injection into the eye to see if they can safely integrate and possibly improve vision. This research is important as it explores a novel approach to potentially slow down or improve the effects of this currently incurable condition. Participants in this study will receive one of two different dose levels of DSP-3077 in one eye. The study will last around 65 months, with initial frequent check-ups, followed by regular visits over several years to monitor the treatment's effects. Participants are divided into three groups based on their vision levels. The main focus is to observe any side effects or improvements in their vision. Long-term monitoring will also be conducted annually from 6 to 15 years after the treatment to ensure its continued safety and effectiveness.

Official TitleA 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)

NCT06891885

Principal SponsorSumitomo Pharma America, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRetinal DegenerationRetinal DiseasesRetinitis PigmentosaEye Diseases, HereditaryGenetic Diseases, InbornRetinal Dystrophies

Criteria

6 inclusion criteria required to participate

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.

Show More Criteria

6 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Best 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

Group II

Experimental

Group III

Experimental

Best 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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Massachusetts Eye and Ear

Boston, United StatesOpen Massachusetts Eye and Ear in Google Maps

Recruiting

One Study Center