A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
NCT ID: NCT06646289
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2024-10-10
2030-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Participants will receive a dose of AAV5 hRKp.RPGR under the retina (low-dose or intermediate-dose) on Day 1 depending on the dosage administered in study MGT009 (NCT03252847) in the past. After receiving the treatment, participants will be assessed for safety.
AAV5-hRKp.RPGR
AAV5-hRKp.RPGR will be administered sub-retinally.
Cohort 2
Participants will receive the treatment dose of AAV5 hRKp.RPGR under the retina (low-dose or intermediate-dose) on Day 1 in the second eye once the safety will be determined in Cohort 1.
AAV5-hRKp.RPGR
AAV5-hRKp.RPGR will be administered sub-retinally.
Cohort 3
The participants who are not willing to undergo surgery or are not eligible for surgery will be assessed in this cohort. They will be assessed yearly until 5 years after their initial eye surgery in previous study MGT009.
No intervention (Follow-Up assessment)
Participants will not receive any intervention and will undergo follow-up assessment.
Interventions
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AAV5-hRKp.RPGR
AAV5-hRKp.RPGR will be administered sub-retinally.
No intervention (Follow-Up assessment)
Participants will not receive any intervention and will undergo follow-up assessment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must sign an informed consent form indicating that they understand the purpose and procedures of the study and is willing to participate in the study
* Willing to adhere to the protocol and long-term follow-up
5 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
Moorfields Eye Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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74765340RPG2001
Identifier Type: OTHER
Identifier Source: secondary_id
74765340RPG2001
Identifier Type: -
Identifier Source: org_study_id