4D-125 IVT Injection for Retinitis Pigmentosa
Phase-Based Progress Estimates
Effectiveness
Safety
Retinitis Pigmentosa+2 More
4D-125 IVT Injection - BiologicalEligibility
Any Age
Male
What conditions do you have?
Select
Eligibility
Any Age
Male
What conditions do you have?
Select
Study Summary
This trial is studying a treatment for non-syndromic X-linked retinitis pigmentosa, a disease that causes blindness.
Eligible Conditions
- Retinitis Pigmentosa
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 24 months to 60 Months
Month 60
measure
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
4D-125 Dose Expansion
1 of 2
4D-125 Dose Exploration
1 of 2
Experimental Treatment
43 Total Participants · 2 Treatment Groups
Primary Treatment: 4D-125 IVT Injection · No Placebo Group · Phase 1 & 2
4D-125 Dose Expansion
Biological
Experimental Group · 1 Intervention: 4D-125 IVT Injection · Intervention Types: Biological4D-125 Dose Exploration
Biological
Experimental Group · 1 Intervention: 4D-125 IVT Injection · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months to 60 months
Who is running the clinical trial?
4D Molecular TherapeuticsLead Sponsor
5 Previous Clinical Trials
176 Total Patients Enrolled
Robert Kim, MDStudy Director4D Molecular Therapeutics
2 Previous Clinical Trials
72 Total Patients Enrolled
Schonmei Lee, MDStudy Director4D Molecular Therapeutics
2 Previous Clinical Trials
122 Total Patients Enrolled
Chyong Nien, MDStudy Director4D Molecular Therapeutics
1 Previous Clinical Trials
65 Total Patients Enrolled
Eligibility Criteria
Age Any Age · Male Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:At least one eye with BCVA ≤ 78 ETDRS letters (~20/32) and ≥ 34 ETDRS letters (~20/200).
You have a hemizygous non-syndromic RPGR mutation.
You are male and you are 12 years of age or older.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Retina Foundation of the Southwest | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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