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Clinical Trials/EUCTR2017-003104-42-DE
EUCTR2017-003104-42-DE
Active, not recruiting
Phase 1

A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RetinalGene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects with X-Linked Retinitis Pigmentosa Previously Treated with Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study

ightstaRx Ltd (A Biogen Company)0 sites330 target enrollmentSeptember 25, 2017
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ightstaRx Ltd (A Biogen Company)
Enrollment
330
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 25, 2017
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ightstaRx Ltd (A Biogen Company)

Eligibility Criteria

Inclusion Criteria

  • •CHM Participants:
  • •a. Are willing and able to give informed consent for participation in the study, and
  • •b. Have participated in and exited from an interventional study that investigated the safety and efficacy of a sub\-retinal injection of AAV2\-REP1 for CHM
  • •XLRP Participants:
  • •a. Are willing and able to give informed consent for participation in the study
  • •b. Have received a sub\-retinal injection of AAV8\-RPGR for XLRP and have exited an antecedent study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 330

Exclusion Criteria

  • •In the opinion of the investigator and/or the Sponsor, it is not in the participant’s best interest to participate in the study.

Outcomes

Primary Outcomes

Not specified

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