A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new treatment option for people with X-Linked Retinitis Pigmentosa (XLRP), a genetic eye condition that affects vision. The study is focusing on the safety and comfort of a specific gene therapy called AAV5 hRKp.RPGR delivered directly into the eye. It aims to help those who have already received this treatment in a previous study and are now considering treatment for their other eye.

To be eligible for this trial, participants must be male, aged between 18 and 26, and have previously been treated with the same gene therapy in earlier studies. They will need to agree to participate by signing a form that explains the study's purpose and procedures. Participants can expect to undergo careful monitoring and follow-up during the study to ensure their safety and to gather important information about the treatment's effects. Overall, this trial hopes to provide valuable insights into how this gene therapy can help improve vision for individuals affected by XLRP.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Have been treated with AAV5-hRKp.RPGR in study MGT009 and have completed or is currently enrolled in Study MGT010
• • 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
• Exclusion Criteria:
• • - There are no specific exclusion criteria to enroll in this study