EUCTR2018-000425-31-GB
Active, not recruiting
Phase 1
ong term follow-up study of participants following an open label, multicentre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy of adults and children with X-linked Retinitis Pigmentosa owing to defects in Retinitis Pigmentosa GTPase Regulator (RPGR) - Long term follow-up gene therapy study for X-linked Retinitis Pigmentosa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
- Sponsor
- MeiraGTx UK II Ltd
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion in the study will be limited to individuals who meet the following criteria:
- •Are able to give informed consent or assent, with or without the guidance of their parent/guardian where appropriate
- •Received AAV2/5\-hRKp.RPGR by sub retinal administration in the prior open\-label, Phase I/II, dose escalation study (EudraCT 2016\-003967\-21\)
- •Are willing to adhere to the protocol and long\-term follow\-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 18
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
ong term follow-up study of gene therapy trial for LCA2 OPTIRPE65eber Congenital Amaurosis (LCA) caused by mutations in RPE65MedDRA version: 20.0Level: PTClassification code 10070667Term: Leber's congenital amaurosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2016-000898-20-GBMeiraGTx UK Ltd27
Active, not recruiting
Phase 1
ong-term follow-up gene therapy study for Achromatopsia (CNGB3)Achromatopsia caused by mutations in the CNGB3 geneMedDRA version: 19.1 Level: LLT Classification code 10000454 Term: Achromatopsia System Organ Class: 100000004850Therapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2016-003856-59-GBMeiraGTX UK II Ltd27
Active, not recruiting
Phase 1
ong term follow-up study of gene therapy trial for X-linked Retinitis PigmentosaEUCTR2018-000425-31-Outside-EU/EEAJanssen-Cilag International NV
Active, not recruiting
Phase 1
ong-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area - Long-term follow-up study of ATX-101 for reduction of localized submental fatReduction of subcutaneous fat in the submental areaMedDRA version: 17.1Level: PTClassification code 10016251Term: Fat tissue increasedSystem Organ Class: 10018065 - General disorders and administration site conditionsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2011-005026-21-DEKYTHERA Biopharmaceuticals, Inc.201
Active, not recruiting
Not Applicable
GLAUrious long-term follow-up study of glaucoma laser treatmentGlaucomaEye DiseasesISRCTN96782911BELKIN Vision192