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Gene Therapy
Gene Therapy with SPVN06 for Cone-Rod Dystrophy (PRODYGY Trial)
Phase 1 & 2
Recruiting
Research Sponsored by SparingVision
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after treatment
Awards & highlights
PRODYGY Trial Summary
This trial tests new treatments for rare eye disease caused by mutations in 3 genes. It includes 2 steps & 3 arms.
Who is the study for?
Adults over 18 with advanced Retinal Cone Dystrophy (RCD) due to specific genetic mutations, who can consent and follow study rules. They must use birth control if they can have children, be in good general health without serious heart, liver or kidney issues, and not pregnant or breastfeeding. Vision loss should be similar in both eyes.Check my eligibility
What is being tested?
The trial is testing SPVN06 gene therapy for RCD in two parts: first, different doses are given to find the safest one; second, patients are randomly put into three groups to compare results while neither doctors nor patients know who gets what treatment.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical gene therapy reactions like immune responses leading to inflammation or discomfort at injection site. Other risks could involve eye-specific reactions since it's an ocular treatment.
PRODYGY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of the safety and tolerability of a single injection of SPVN06 in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene, 12 months after administration of gene therapy.
Secondary outcome measures
Evaluation of preliminary efficacy as assessed by FAF
Evaluation of preliminary efficacy as assessed by adaptive optics imaging
Evaluation of preliminary efficacy as assessed by color vision
+8 moreOther outcome measures
Exploratory objective
PRODYGY Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Step 2 : SPVN06 Dose Recommended 2Experimental Treatment1 Intervention
Participants will receive a single subretinal injection of SPVN06 recommended dose 2 on Day 0
Group II: Step 2 : SPVN06 Dose Recommended 1Experimental Treatment1 Intervention
Participants will receive a single subretinal injection of SPVN06 recommended dose 1 on Day 0
Group III: Step 1 : SPVN06 dose 3Experimental Treatment1 Intervention
Participants will receive a single subretinal injection of SPVN06 Dose 3 on Day 0
Group IV: Step 1 : SPVN06 dose 2Experimental Treatment1 Intervention
Participants will receive a single subretinal injection of SPVN06 Dose 2 on Day 0
Group V: Step 1 : SPVN06 dose 1Experimental Treatment1 Intervention
Participants will receive a single subretinal injection of SPVN06 Dose 1 on Day 0.
Group VI: Step 2 : Control groupActive Control1 Intervention
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Who is running the clinical trial?
SparingVisionLead Sponsor
2 Previous Clinical Trials
195 Total Patients Enrolled
2 Trials studying Retinitis Pigmentosa
195 Patients Enrolled for Retinitis Pigmentosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had COVID-19 in the last 2 weeks.I cannot tolerate corticosteroids.I am 18 years old or older.I have not received a live vaccine in the last 4 weeks.I have been diagnosed with refractory celiac disease.I have eye problems that could affect vision tests.I have had surgery on the vitreous or macula of my eye.I am not on any immunosuppressive therapies not listed in the study.I might have or currently have an eye infection.I have received gene or stem cell therapy before.I am HIV positive or have a disease that weakens my immune system.I have severe lung problems or diseases that block my airways.I have a health condition not related to RCD that could affect my vision.I have narrow angles in my eyes that prevent pupil dilation.I have a condition that is causing me to lose my vision.I am currently being treated for cancer or my cancer is active.I have advanced RCD with specific genetic mutations.My condition is due to genetic mutations not mentioned in the study criteria.I have active Hepatitis B or C.I currently have an active herpes infection.I haven't had major eye surgery in the last 6 months.I have a serious heart condition.I have high eye pressure that isn't controlled by medication.I have had cancer in my eye.I have an eye condition that affects my central vision.I have active eye inflammation or a history of uveitis.I have a weakened immune system due to a previous transplant.My advanced RCD is due to certain gene mutations.I have a history of glaucoma.My liver or kidneys are not working properly.My blood pressure is not stable or under control.I have recently received or plan to receive a COVID-19 vaccine.My hormone-related condition is not under control.I have active tuberculosis.I am legally considered unable to make my own decisions.My vision is severely or moderately impaired in both eyes.My vision is significantly impaired in both eyes due to my condition.I have been diagnosed with RCD based on my symptoms and family history.
Research Study Groups:
This trial has the following groups:- Group 1: Step 2 : Control group
- Group 2: Step 1 : SPVN06 dose 1
- Group 3: Step 1 : SPVN06 dose 2
- Group 4: Step 1 : SPVN06 dose 3
- Group 5: Step 2 : SPVN06 Dose Recommended 1
- Group 6: Step 2 : SPVN06 Dose Recommended 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Retinitis Pigmentosa Patient Testimony for trial: Trial Name: NCT05748873 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitments still open for this clinical trial?
"The clinicaltrials.gov website affirms that this trial, initially posted on February 1st 2023, is not currently recruiting participants. Despite this study's lack of recruitment activity, there are 51 other studies actively searching for volunteers at the moment."
Answered by AI
Who else is applying?
What site did they apply to?
CHNO XV-XX Paris - CIC 1423
UPMC Eye Center
Natalie Anthony
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
Minnesota
Pennsylvania
Florida
Other
Why did patients apply to this trial?
To cure my RP. I’ll try anything 🙏🏼. I know there is no cure as of right now, and even if this is the one, I probably couldn't afford buying it after it's launched.
PatientReceived 2+ prior treatments
I have retinitis pigmentosa and i am loosing mi vision fast i am currently legally blind and i an hoping your research will help us beating the condition.
PatientReceived 2+ prior treatments
Me and my twin sister are both suffering from RP that deteriorates gradually. I, and possibly her as well, would like to seek for promising therapeutic clinical trial to alleviate our condition.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Natalie Anthony: < 48 hours
Average response time
- < 2 Days
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