Health TrialsbyHealthPanel

Gene Therapy for Subjects With RPGR Mutation-associated X-linked Retinitis Pigmentosa

ConditionX-Linked Retinitis Pigmentosa
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age8-45
SponsorFrontera Therapeutics

About this trial

A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • FT-002

    Genetic

    Comparison of different dosages of FT-002

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Low dose FT-002Experimental treatment 1 intervention
Group B: Intermediate dose FT-002Experimental treatment 1 intervention
Group C: High dose FT-002Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of AEs

Number and proportion of Adverse Events

Time frame
from FT-002 administration through up to 1 years

Secondary outcomes

1

Change in visual function

Change in retinal function as assessed by mean retinal sensitivity within the 30-degree visual field

Time frame
from FT-002 administration through up to 1 years
2

Change in retinal structure as assessed by Optical Coherence Tomography

Change in Outer Nuclear Layer Thickness from baseline as assessed by Optical Coherence Tomography

Time frame
from FT-002 administration through up to 1 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Frontera Therapeutics

Lead sponsor

Eye & ENT Hospital of Fudan University

Collaborator

Peking Union Medical College Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov
Apply now