Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-60
SponsorZhongmou Therapeutics

About this trial

This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).

Eligibility criteria

Qualifiers

Male or female participants aged 6 to 60 years.

Clinical diagnosis of advanced retinitis pigmentosa (RP).

Best corrected visual acuity at or below the protocol-defined threshold in the study eye.

Presence of sufficient retinal structure in the study eye as determined by screening assessments.

Disqualifiers

Presence of other ocular conditions that could interfere with study assessments.

History of significant ocular surgery in the study eye within a protocol-defined period.

Active ocular infection or inflammation.

Clinically significant systemic disease that could increase study risk or interfere with assessments.

Trial design

Treatments tested in this trial

  • ZM-02 (low dose)
  • ZM-02 (high dose)
  • ZM-02 (selected dose)
  • Sham injection

Treatment groups

21 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators