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Virus Therapy
RTx-015 for Retinitis Pigmentosa
Phase 1
Recruiting
Research Sponsored by Ray Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of Retinitis Pigmentosa independent of causative mutation
Be older than 18 years old
Must not have
Prior receipt of any gene therapy (ocular or other), retinal implant, or ocular cell therapy
Prior vitrectomy or aphakia in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effectiveness of RTx-015 in patients with retinitis pigmentosa. About 9 patients will receive a single injection of RTx-015 in one eye and
Who is the study for?
This trial is for about 9 people with retinitis pigmentosa, a degenerative eye condition. Participants will receive one injection in the affected eye and be monitored for a year. Details on specific inclusion or exclusion criteria are not provided.
What is being tested?
The study tests RTx-015, given as a single intravitreal (into the eye) injection to see if it's safe at different doses. It's an early-phase trial without randomization, focusing on dose safety over 12 months.
What are the potential side effects?
Specific side effects of RTx-015 aren't listed here, but typical risks may include eye irritation, discomfort at the injection site, increased intraocular pressure, or vision changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Retinitis Pigmentosa.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never received gene, retinal, or ocular cell therapy.
Select...
I have had eye surgery in the eye being studied.
Select...
I am not allergic to any drugs used in this study.
Select...
My eye pressure didn't lower with usual drops after steroid treatment.
Select...
I have a condition or take medication that affects my immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Best Corrected Visual Acuity (BCVA) at Month 6 and Month 12
Contrast Sensitivity at Month 6 and Month 12
Full-field static visual field testing at Month 6 and Month 12
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Middle Dose RTx-015Experimental Treatment1 Intervention
Single intravitreal injection of middle dose RTx-015
Group II: Low Dose RTx-015Experimental Treatment1 Intervention
Single intravitreal injection of low dose RTx-015
Group III: High Dose RTx-015Experimental Treatment1 Intervention
Single intravitreal injection of high dose RTx-015
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Who is running the clinical trial?
Ray Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Retinitis Pigmentosa
40 Patients Enrolled for Retinitis Pigmentosa