Clinical trials

7

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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

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).

Participants needed: 32
Trial details
Phase: Phase 1, Phase 2Age: 8-45Biological sex: MaleType: InterventionalSponsor: Frontera TherapeuticsUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Subjects that are willing and able to follow study procedures including schedule... [+2]

Have other retinal degenerative diseases, such as retinal degeneration caused by...

Status: Recruiting

Gene Therapy(FT-003) for Wet AMD

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Participants needed: 78
Trial details
Phase: Phase 1, Phase 2Age: 50-80Biological sex: AllType: InterventionalSponsor: Frontera TherapeuticsUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Subjects that are willing and able to follow study procedures; [+4]

•Presence of any other intraocular diseases other than nAMD in the studied eye t...

Status: Recruiting

Gene Therapy for DME

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Participants needed: 78
Trial details
Phase: Phase 1, Phase 2Age: 18-74Biological sex: AllType: InterventionalSponsor: Frontera TherapeuticsUpdated: Jul 9, 2024Locations: 1
Eligibility criteria

Subjects that are willing and able to follow study procedures; [+3]

Presence of any other intraocular diseases other than DME in the studied eye tha...

Status: Recruiting

Gene Therapy for Diabetic Macular Edema

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

Participants needed: 18
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Frontera TherapeuticsUpdated: Jun 23, 2023Locations: 1
Eligibility criteria

Subjects that are willing and able to follow study procedures; [+4]

Presence of any other intraocular diseases other than CI-DME in the studied eye...

Status: Recruiting

Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy.

Participants needed: 9
Trial details
Phase: Phase 1, Phase 2Age: 8-45Biological sex: AllType: InterventionalSponsor: Frontera TherapeuticsUpdated: May 15, 2023Locations: 1
Eligibility criteria

Subjects who are able to understand and sign the ICF [+2]

Other interfering eye diseases [+6]

Status: Not yet recruiting

Gene Therapy for Wet AMD

FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Participants needed: 18
Trial details
Phase: Phase 1Age: 45+Biological sex: AllType: InterventionalSponsor: Frontera TherapeuticsUpdated: Apr 26, 2023
Eligibility criteria

Subjects that are willing and able to follow study procedures; [+4]