An Early Phase 1 interventional study of FT-002 in X-Linked Retinitis Pigmentosa, sponsored by Frontera Therapeutics. Recruiting at 2 sites in China. Open to male participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Frontera Therapeutics · Early Phase 1, Interventional, and Treatment
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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.
Among the 17 studies in Retinitis Pigmentosa with a site in China, this one is the 10th largest by planned enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2023, is one of 8 in phase 1, reaches primary completion later than 0 of the 12 other live ones, and was the 9th registered.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
Browse Retinitis Pigmentosa studies →12 of the 17 studies in Retinitis Pigmentosa with a site in China are open now. Recruiting first, the newest first:
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18+
Chigenovo Co., Ltd · Sites in China
Ages 18+
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18+
Frontera Therapeutics · Sites in China
Ages 8–45 · Men only
Zhongmou Therapeutics · Sites in China
Ages 18–65
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 →
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.
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17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 3 · Phase 3 1
First in 2005; this study’s year is marked. 4 started in 2023.
This study's planned enrollment of 18 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Median enrollment 25 across the 15 interventional studies, 2,149 across the 2 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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5 of 17 have an industry lead sponsor. The 10 most frequent:
Frontera Therapeutics is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
Frontera Therapeutics has 2 studies filed under Retinitis Pigmentosa — fewer than ten, so there is no comparison to draw.
4 of the studies in Retinitis Pigmentosa with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05805007Peking University Third HospitalSafety and Tolerability Study of Gene Editing Drug ZVS203e in Participants With Retinitis Pigmentosa | 2026-12 |
| NCT03944239Qi ZhouSafety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa | 2026-12-31 |
| NCT07311863Suzhou UgeneX Therapeutics Co., Ltd.UGX202 Injection in Patients With Advanced Retinitis Pigmentosa | 2027-03 |
| NCT07126470Zhongshan Ophthalmic Center, Sun Yat-sen UniversityImpact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 17 studies in Retinitis Pigmentosa with a site in China, from their registry updates:
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A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).
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.
1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Form; 4.Subjects who are confirmed with variants of RPGR ;
Exclusion Criteria:
1.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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intraocular injection of a single low dose of FT-002
Genetic: FT-002
Intraocular injection of a single Intermediate dose of FT-002
Genetic: FT-002
Intraocular injection of a single High dose of FT-002
Genetic: FT-002
Comparison of different dosages of FT-002
Incidence of AEs
Number and proportion of Adverse Events
Time frame: from FT-002 administration through up to 1 years
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
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
Plan to share: No — Researchers qualified can request the dataset, including de-identified individual subject data.
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Oct 2023, 8 months after the start.
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Frontera Therapeutics