A Safety Study of Contralateral Eye Dosing of VGR-R01 in Participants With Bietti's Crystalline Dystrophy (BCD)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-69
SponsorShanghai Vitalgen BioPharma Co., Ltd.

About this trial

This is a multi-centre, single- arm, non-randomized, open-label phase 1/2 clinical trial which enables dosing of the fellow eyes of patients who received VGR-R01 administration in previous studies.

Eligibility criteria

Qualifiers

Participants received VGR-R01 administration in the VGR-R01-001 or VGR-R01-101 studies.

Able to provide informed consent and comply with requirements of the study;

Hand Motion ≤ BCVA ≤ 75 ETDRS letters in the second treated eye.

Disqualifiers

Have insufficient viable retinal photoreceptor cells based on investigator's decision;

Have current ocular or periocular infections, or endophthalmitis;

Have any significant ocular disease/disorder other than BCD, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc;

Have intraocular surgery history except cataract surgery in the study eye;

Trial design

Treatments tested in this trial

  • VGR-R01

Treatment groups

15 Participants
are divided into 1 treatment group