General Information |
| 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. |
| 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 65 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. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2025-05-01 |
| End date (estimated) |
2032-10-31 |
| Clinical feature |
| Label |
retinitis pigmentosa |
| Link |
http://purl.obolibrary.org/obo/DOID_10584 |
| Description |
A retinal degeneration characterized by the gradual deterioration of the photoreceptors or the retinal pigment epithelium of the retina leading to progressive sight loss.; Xref MGI. OMIM mapping confirmed by DO. [LS]. |
|
Administrative Information |
| NCT number |
NCT06891885 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06891885 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/study/NCT06891885 |
| Sponsors |
Sumitomo Pharma America, Inc.
|
Cells |
| Which differentiated cell type is used |
| Label |
retina |
| Link |
http://purl.obolibrary.org/obo/UBERON_0000966 |
| Description |
The retina is the innermost layer or coating at the back of the eyeball, which is sensitive to light and in which the optic nerve terminates.; Currently this class encompasses only verteberate AOs but could in theory also include cephalopod - we may want to make a more specific class for vertebrate retina. note that this class excludes ommatidial retinas, as the retina must be part of an eyeball. Use the parent class photoreceptor array / light-sensitive tissue for arthropods |
|
Recruitment |
| Recruitment Status |
Not yet recruiting |
| Estimated number of participants |
12 |
