Health TrialsbyHealthPanel

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

ConditionRetinitis Pigmentosa
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSumitomo Pharma America, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DSP-3077 Retinal Sheet Cohort 1

    Drug

    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

    Drug

    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

    Drug

    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

Treatment groups

12 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of ocular adverse events (AEs)

Time frame
60 months
2

Incidence of ocular serious adverse events (SAEs)

Time frame
60 months
3

Incidence of ocular adverse events (AEs) leading to discontinuation

Time frame
60 months
4

Incidence of adverse events (AEs)

Time frame
60 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sumitomo Pharma America, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now