Step 2 : SPVN06 Dose Recommended 1 for Retinitis Pigmentosa

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC Eye Center, Pittsburgh, PARetinitis PigmentosaSPVN06 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial tests new treatments for rare eye disease caused by mutations in 3 genes. It includes 2 steps & 3 arms.

Eligible Conditions
  • Retinitis Pigmentosa

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: up to 6 months after treatment

Month 12
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.
Year 5
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
Evaluation of preliminary efficacy as assessed by optical coherence tomography
Evaluation of preliminary efficacy as assessed by quality of life
Evaluation of preliminary efficacy as assessed by retinal sensitivity
Evaluation of preliminary efficacy as assessed by visual acuity
Evaluation of preliminary efficacy as assessed by visual field
Evaluation of the immune response against the viral vector of SPVN06 up to 5 years after treatment administration.
Evaluation of the long-term 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, up to 5 years after treatment administration.
Exploratory objective
Month 6
Evaluation of viral shedding and bio-dissemination up to 6 months after treatment administration.

Trial Safety

Safety Progress

1 of 3

Trial Design

6 Treatment Groups

Step 2 : Control group
1 of 6
Step 2 : SPVN06 Dose Recommended 1
1 of 6
Step 1 : SPVN06 dose 1
1 of 6
Step 1 : SPVN06 dose 2
1 of 6
Step 2 : SPVN06 Dose Recommended 2
1 of 6
Step 1 : SPVN06 dose 3
1 of 6

Active Control

Experimental Treatment

33 Total Participants · 6 Treatment Groups

Primary Treatment: Step 2 : SPVN06 Dose Recommended 1 · No Placebo Group · Phase 1 & 2

Step 2 : SPVN06 Dose Recommended 1
Drug
Experimental Group · 1 Intervention: SPVN06 · Intervention Types: Drug
Step 1 : SPVN06 dose 1
Drug
Experimental Group · 1 Intervention: SPVN06 · Intervention Types: Drug
Step 1 : SPVN06 dose 2
Drug
Experimental Group · 1 Intervention: SPVN06 · Intervention Types: Drug
Step 2 : SPVN06 Dose Recommended 2
Drug
Experimental Group · 1 Intervention: SPVN06 · Intervention Types: Drug
Step 1 : SPVN06 dose 3
Drug
Experimental Group · 1 Intervention: SPVN06 · Intervention Types: Drug
Step 2 : Control groupNoIntervention Group · 1 Intervention: Step 2 : Control group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after treatment

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

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.