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Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)

Sponsored by MeiraGTx UK II Ltd

About this trial

Last updated 3 years ago

Study ID

MGT009

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
5+ Years
Male
Male

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

The Phase 1 part of the study is a dose escalation of subretinal administration of AAV2/5 vector to assess the safety of this vector in participants with XLRP caused by mutations in RPGR. The Phase 2 part of the study is a cohort expansion of subretinal administration of AAV2/5 vector to assess the safety and efficacy of this vector in participants with XLRP caused by mutations in RPGR.

What are the Participation Requirements?

Key inclusion Criteria:

- Are aged 5 years or older male

- Have X-linked retinitis pigmentosa confirmed by a retinal specialist (CI or PI)

Key exclusion Criteria:

• Have participated in another research study involving an investigational medicinal
therapy for ocular disease within the last 6 months