ClinicalTrials.gg
RecruitingNCT06492850Updated Jul 9, 2024

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

A Phase 1/2 interventional study of FT-002 in X-Linked Retinitis Pigmentosa (XLRP), sponsored by Frontera Therapeutics. Recruiting at 1 site in China. Open to male participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Frontera Therapeutics · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Apr 2024, registered Jul 2024).
  • Started Apr 2024; still recruiting 2 years 7 months later.

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Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
8 Years to 45 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Retinitis Pigmentosa with a site in China — 12 open to participants now, 13 under way, 1 of them phase 3. Retinitis Pigmentosa · China.

Planned enrollment
6th of 15
32 · median 25
Started
2024
with 1 other
Phase 1/2
2 of 17
2 open now
Primary completion
2025-08
later than 3 of 12 live
Registered
12th of 17
by date
Lead sponsor
2 of 17
Frontera Therapeutics

Among the 17 studies in Retinitis Pigmentosa with a site in China, this one is the 6th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2024, is one of 2 in phase 1/2, reaches primary completion later than 3 of the 12 other live ones, and was the 12th registered.

Retinitis Pigmentosa

278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.

Browse Retinitis Pigmentosa studies →

Open to participants now

12 of the 17 studies in Retinitis Pigmentosa with a site in China are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 49 Retinitis Pigmentosa studies recruiting now, 37 (76%) set no upper age limit and 7 (14%) stop at 75 or younger; 16 take children under 18; 10 take healthy volunteers.

This study: 8 Years to 45 Years · male · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Retinitis Pigmentosa with a site in China, or all of them as a file.
02

Study summary

The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).

03

Conditions studied

  • X-Linked Retinitis Pigmentosa (XLRP)

Browse trials for

Keywords

  • X-Linked Retinitis Pigmentosa (XLRP)
  • FT-002
04

Who can participate

Ages eligible
8 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written form;
  • Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;
  • Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;

Exclusion criteria

Exclusion Criteria:

  • Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    FT-002 dose 1

    Low dose FT-002

    Genetic: FT-002

  • Experimental
    High dose FT-002

    High dose FT-002

    Genetic: FT-002

Interventions

  • GeneticFT-002

    Intraocular injection of a single dose

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerance of FT-002

    Incidence and severity of AEs

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

Secondary outcomes

  1. To evaluate the efficacy of FT-002

    Changes in visual sensitivity /FST/BCVAfrom baseline

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Aug 2025, 16 months after the start.

Of 28 phase 1/2 interventional studies under Retinitis Pigmentosa, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 92. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2024
First posted
Jul 9, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Aug 1, 2025
CompletionEst.
Feb 1, 2026
Last update
Jul 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06492850
Lead sponsor
Frontera Therapeutics
Responsible party
Sponsor
First posted
Jul 9, 2024
Start date
Apr 1, 2024
Primary completion
Aug 1, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Jul 9, 2024

Study contacts

Xinyan Li
Contact
xinyan.li@fronteratherapeutics.com
+86-021-58206061
Minghui Xue
Contact
minghui.xue@fronteratherapeutics.com
+86-021-58206061
Ruifang Sui
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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