DSP-3077 for Retinitis Pigmentosa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called DSP-3077 for individuals with retinitis pigmentosa, a condition that gradually leads to vision loss. The main goal is to assess the safety and tolerability of this treatment when administered in a single dose and to evaluate its effects on vision. Participants are divided into three groups based on their vision levels to test different doses. This trial may suit those with a confirmed diagnosis of retinitis pigmentosa who experience significant vision loss in one eye. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have participated in another clinical trial or received experimental treatment for an eye condition recently, you may not be eligible.
Is there any evidence suggesting that DSP-3077 is likely to be safe for humans?
Research has shown that DSP-3077 is undergoing safety testing for retinitis pigmentosa, a condition that causes vision loss. In related studies, patients have received a single injection of DSP-3077 in one eye. The treatment remains in the early testing stages, focusing primarily on safety and the body's reaction to the drug. Detailed safety information is still limited due to the early phase of testing. However, these initial tests help researchers identify any side effects and assess their severity, ensuring the treatment's safety for future use.
Specific safety results are not yet available, so potential trial participants should understand that discovering this information is a key study goal. This phase indicates that while the treatment has passed initial lab tests, its safety in humans is still under careful examination.12345Why do researchers think this study treatment might be promising for retinitis pigmentosa?
Researchers are excited about DSP-3077 for retinitis pigmentosa because it offers a novel approach compared to existing treatments. While most current options, like vitamin A supplements and vision aids, focus on slowing progression or managing symptoms, DSP-3077 targets the underlying mechanisms of the disease. This treatment is designed to improve visual acuity by potentially restoring some degree of sight, rather than just preserving existing vision. This innovative mechanism gives hope for enhanced outcomes in patients with varying degrees of vision loss.
What evidence suggests that DSP-3077 might be an effective treatment for Retinitis Pigmentosa?
Research has shown that DSP-3077 could be a promising treatment for retinitis pigmentosa, a disease that causes vision loss. This treatment uses special sheets made from stem cells to replace damaged cells in the eye. Early results suggest these stem cell therapies might slow the disease and help restore some vision. Although still in the early stages, this approach offers hope for people with retinal diseases once thought untreatable. In this trial, participants will be divided into different cohorts to assess their tolerance of DSP-3077 and any improvements in vision.13678
Are You a Good Fit for This Trial?
This trial is for men and women over 18 with retinitis pigmentosa, who are willing to undergo genetic testing. Participants must have specific levels of visual acuity depending on the cohort they're assigned to. They should be in good health as determined by medical history, exams, and various tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subretinal uniocular injection of DSP-3077
Initial Follow-up
Participants are monitored monthly through Month 4 after treatment
Extended Follow-up
Participants are monitored every 3 months through Month 24 and every 6 months through Month 60
Long-term Follow-up
Long-term safety data collection annually from 6 years to 15 years after DSP-3077 administration
What Are the Treatments Tested in This Trial?
Interventions
- DSP-3077
Trial Overview
The study is testing the safety and effects of a single dose of DSP-3077 delivered via an eye injection. It's divided into three cohorts based on vision sharpness and dosage level, with each group having four participants.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumitomo Pharma America, Inc.
Lead Sponsor
Jatin Shah
Sumitomo Pharma America, Inc.
Chief Medical Officer since 2024
MD from an unspecified institution
Tsutomu Nakagawa
Sumitomo Pharma America, Inc.
Chief Executive Officer since 2024
MBA from Waseda University
Citations
A Study to Investigate the Safety of DSP-3077 After ...
Study Overview The Goal of this study is to evaluate the safety, tolerability, and clinical responses following single dose of DSP-3077. Study enrolls both ...
Initiation of Phase1/2 Study on Allogeneic iPS Cell-derived ...
Sumitomo Pharma will conduct the clinical study with the objective of offering a new treatment option to retinitis pigmentosa patients as early as possible.
3.
araceagainstblindness.org
araceagainstblindness.org/blogs/news/stem-cell-derived-retinal-sheets-enter-clinical-trial-for-retinitis-pigmentosa?srsltid=AfmBOopTjnkFEMGWF3dwY5Ofuy3GPBXwPIML3xB7fMiW4u5qQL4hiE-CStem Cell–Derived Retinal Sheets for RP Trial
While much work remains, DSP-3077 highlights the growing promise of stem cell–based therapies in tackling retinal diseases once considered ...
Top Retinitis Pigmentosa Clinical Trials | Power
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 ...
Retinitis Pigmentosa (RP) (DBCOND0056216) - DrugBank
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 ...
6.
araceagainstblindness.org
araceagainstblindness.org/blogs/news/stem-cell-derived-retinal-sheets-enter-clinical-trial-for-retinitis-pigmentosa?srsltid=AfmBOoqDdn1GBpgR_UmDwdyx0IQX4TA83gzyG44HgLqdGAhyJRN3fkb0Stem Cell–Derived Retinal Sheets for RP Trial
Stem Cell–Derived Retinal Sheets enter clinical trial for Retinitis Pigmentosa, exploring new hope for patients with regenerative therapy.
7.
app.trialscreen.org
app.trialscreen.org/trials/phase-1-2-to-investigate-safety-dsp-3077-after-unilateral-eye-injection-trial-nct06891885A Study to Investigate the Safety of DSP-3077 After ...
Participants in this study will receive an investigational cell therapy that has the potential to improve vision or slow the progression of vision loss in ...
DSP-3077 - Drug Targets, Indications, Patents
A Prospective, Open-label, Single-arm, Dose-escalation Study of the Safety and Tolerability of a Single Subretinal Uniocular Injection of Allogeneic Induced ...
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