Clinical Trials in the USA / 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 USA tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 USA
Other trials for the same condition
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
Active, not recruiting
A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN)
Enrolling by invitation
A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)
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 USA