Recruiting
Phase 1
Phase 2

DSP-3077

Sponsor:

Sumitomo Pharma America, Inc.

Code:

NCT06891885

Conditions

Retinitis Pigmentosa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DSP-3077 Retinal Sheet Cohort 1

DSP-3077 Retinal Sheet Cohort 2

DSP-3077 Retinal Sheet Cohort 3

Study Details

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 defined by visual acuity (VA) criteria and dose level of DSP-3077. Each cohort will include 4 participants.

Conditions

Retinitis Pigmentosa

Study ID

NCT06891885

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Oct 31, 2032

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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

experimental: Cohort 2

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

experimental: Cohort 3

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

Interventions

DSP-3077 Retinal Sheet 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 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 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

Primary outcome measure

  • Incidence of ocular adverse events (AEs) [ Time Frame: 60 months ]
  • Incidence of ocular serious adverse events (SAEs) [ Time Frame: 60 months ]
  • Incidence of ocular adverse events (AEs) leading to discontinuation [ Time Frame: 60 months ]
  • Incidence of adverse events (AEs) [ Time Frame: 60 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: 60 months ]
  • Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: 60 months ]
  • Incidence of adverse events (AEs) leading to death [ Time Frame: 60 months ]

Central Contacts and Locations

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Albert Cheng

617-573-6060acheng18@meei.harvard.edu

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Jacob Stauffer

612-625-4108jstauffe@umn.edu

More Information

Sponsor

Sumitomo Pharma America, Inc.

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sumitomo Pharma America, Inc. on 2026-04-17.