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Tests treatment safety and results for Retinitis Pigmentosa
Official title 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
ClinicalTrials.gov ID: NCT06891885
What this study is testing
What is DSP-3077 Retinal Sheet Cohort 1?
DSP-3077 Retinal Sheet Cohort 1 is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for retinitis pigmentosa.
Also referred to as Cohort 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Cohort 3: Participant will have BCVA in the study eye between 20 ETDRS letter score (approximately \>= 20/400 Snellen equivalent) and 35 ETDRS letter...
You likely can't join if
- 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...
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the...
- 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)...
- Participant has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an...
See the full eligibility 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...
- Participant is in good physical health, based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests at Screening.
- 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...
- 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...
- 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 treatment clinical trial for an eye...
- Participant has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.