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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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Gene therapy for Retinitis Pigmentosa (RP) involves delivering a functional copy of the defective gene to retinal cells using viral vectors. This helps restore the production of essential proteins, improving or stabilizing vision.
This treatment is crucial for RP patients as it addresses the root cause of the disease at the genetic level, potentially halting or reversing vision loss.
The safety and efficacy of gene therapy treatment for monogenic retinal and optic nerve diseases: A systematic review.
The safety and efficacy of gene therapy treatment for monogenic retinal and optic nerve diseases: A systematic review.
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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
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