Study of Safety and Tolerability of DSP-3077 Eye Injection in Adults With Retinitis Pigmentosa

What this Trial Is About

Researchers are evaluating the safety, tolerability, and clinical responses after a single dose of DSP-3077 in adults with retinitis pigmentosa RP. This Phase 12a, open-label, single-arm study involves three groups defined by their visual acuity and dose level of DSP-3077. The study aims to assess safety, engraftment, and potential therapeutic effects of DSP-3077 retinal sheets delivered subretinally. Participants will receive a single subretinal injection of DSP-3077 in one eye, with two dose levels tested across three cohorts. Each cohort will have 4 participants, totaling 12 adults. Cohorts 1 and 2 receive lower and higher doses respectively, while cohort 3 involves participants with better visual acuity receiving a high dose. The treatment uses a specialized delivery device for the injection. The study lasts about 67 months, starting with a 2-week period of frequent visits post-surgery, then monthly visits until month 4, followed by visits every 3 months up to month 24, and every 6 months up to month 60. Long-term safety data will be collected annually from years 6 to 15 after treatment. Researchers will monitor ocular adverse events, serious adverse events, and treatment tolerability throughout the study.

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