Phase
Condition
Retinitis Pigmentosa
Eye Disorders/infections
Eye Disease
Treatment
VP-001
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male or female sex; ≥18 years of age at Day 1/Baseline (Visit 2)
May have been previously enrolled in PLATYPUS Part B (Protocol #VP001-CL101) orWALLABY (Protocol #VP001-CL102) study. At Screening Visit in this study,participants must have completed at least 8 weeks after last study agentadministration in PLATYPUS Part B (Protocol #VP001-CL101) or WALLABY (Protocol #VP001-CL102) study
Have a confirmed clinical diagnosis of Retinitis Pigmentosa.
Have a confirmed genetic diagnosis of Retinitis Pigmentosa secondary to mutation inthe PRPF31 gene.
For participants not previously enrolled in VP001-CL101 or VP001-CL102 studies: Meetall of the following for visual function in the study eye at the Screening Visit:
Mean microperimetry threshold: >5 decibel (dB) to <15 dB
Ellipsoid zone (EZ) length >1000 microns of which 500 microns is contiguous, bySD-OCT
In the opinion of the Investigator, rod function is observed in any direction >10 degrees per static perimetry at Screening Visit (Visit 1)
Exclusion
Key Exclusion Criteria:
Have any uncontrolled systemic disease that, in the opinion of the Investigator,would preclude participation in the study that include but are not limited toinfection, uncontrolled elevated blood pressure, cardiovascular disease, or glycemiccontrol issues, or any other medical condition that may put the participant at riskdue to study procedures.
Known mutations in genes that cause autosomal dominant RP, X-linked RP, or presenceof biallelic mutations in autosomal recessive RP/retinal dystrophy genes other thanPRPF31 mutations.
Have used anti-VEGF agents within 2 months or corticosteroid injections within thelast 3 months.
Have had Ozurdex® implants placed within 3 months or Retisert® or Iluvien® implantsplaced within 3 years prior to Baseline (Visit 2).
Within 3 months prior to Baseline (Visit 2), have undergone any vitreoretinalsurgery or any other ocular surgery
Have ocular media opacity or poor pupillary dilation prohibiting quality ophthalmicevaluation or photography, as assessed by the investigator.
Have used any investigational drug or device within 90 days or 5 estimatedhalf-lives (or within 60 days from last administration of VP-001 in the VP001-CL101Part B or VP001-CL102 studies) of Baseline (Visit 2), whichever is longer,
Have a recent history (<6 months) or current excessive recreational drug or alcoholuse, in the opinion of the investigator.
Study Design
Connect with a study center
University of Florida College of Medicine
Jacksonville, Florida 32209
United StatesSite Not Available
Bascom Palmer Eye Institute - University of Miami
Miami, Florida 33136
United StatesSite Not Available
University of Florida College of Medicine
Jacksonville 4160021, Florida 4155751 32209
United StatesActive - Recruiting
Bascom Palmer Eye Institute - University of Miami
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan 48105
United StatesSite Not Available
Kellogg Eye Center - University of Michigan
Ann Arbor 4984247, Michigan 5001836 48105
United StatesActive - Recruiting
Casey Eye Institute - OHSU
Portland, Oregon 97239
United StatesSite Not Available
Casey Eye Institute - OHSU
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Retina Foundation of the Southwest
Dallas, Texas 75231
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Retina Foundation of the Southwest
Dallas 4684888, Texas 4736286 75231
United StatesActive - Recruiting
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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