Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the UK / NCT06646289
Active, not recruiting Phase 2

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

NCT06646289 · tracked via the Priya Life Science UK tracker
Sponsor
MeiraGTx Ocular UK Ltd
Phase
Phase 2
Started
2024-10-10
Last updated
2026-09-25

Condition(s) studied

X-Linked Retinitis Pigmentosa

Investigational drug(s) / intervention(s)

AAV5-hRKp.RPGRNo intervention (Follow-Up assessment)

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.

Study summary

The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.

Eligibility

Sex
MALE
Min age
5 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants With Adverse Events (AE) — From baseline up to 5.5 years
    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
  • Change from Baseline in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Letter Scores — Baseline, Months 12, 24, 36, 48 and 60
    Change from baseline in BCVA by ETDRS chart letter scores in monocular assessment of the second treated eye will be assessed. BCVA was measured using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. An increase in the number of letters read correctly means that vision has improved and vice-versa.
  • Change from Baseline in Low Luminance Visual Acuity (LLVA) by ETDRS Chart Letter Score — Baseline, Months 12, 24, 36, 48 and 60
    Change in LLVA by ETDRS chart letter scores from baseline in monocular assessment of second treated eye will be assessed. Visual function assessments included LLVA assessment in each eye by ETDRS letters. The letter score ranges from 0 (worse score) to 100 (best score), and a gain in LLVA from baseline indicates an improvement in visual acuity.

Trial sites (3)

FacilityCityRegionStatus
Massachusetts Eye and Ear Infirmary Boston Massachusetts
University of Michigan Kellogg Eye Center Ann Arbor Michigan
Moorfields Eye Hospital London United Kingdom

More MeiraGTx Ocular UK Ltd trials in the UK

Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene Active, not recruiting

Other trials for the same condition

A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP Active, not recruiting
Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06646289 on ClinicalTrials.gov ↗ ← All trials in the UK