Recent Updates
Recently added Catalysts

FT-003

Phase 1

Diabetic Macular Edema | Gene therapy | Ophthalmology |cbdMD, Inc.|Last Updated: Jun 23, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

FT-003 · 1 trial · 1 indication

Phase 1 1
NCT05916391Gene Therapy for Diabetic Macular EdemaDiabetic Macular Edema
RECRUITING18 Analytics
PHASE1RECRUITING
Gene Therapy for Diabetic Macular Edema
Diabetic Macular EdemaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability after FT-003 injection
Whthin 52 weeks after administration

Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

Secondary Endpoints

Preliminary effectiveness after FT-003 injection
Whthin 52 weeks after administration
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FT003 Dose 1EXPERIMENTALLow dose of FT-003
FT003 Dose 2EXPERIMENTALMid dose of FT-003
FT003 Dose 3EXPERIMENTALHigh dose of FT-003

Interventions

NameTypeDescription
FT-003GENETICAdministration via intraocular injection
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects that are willing and able to follow study procedures; * Female or male patients ≥18 years old at the time of signing the ICF; * Clinically diagnosed with CI-DME * HbA1c≤10% * The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters Exclusion Criteri...

Countries:China
Unlock Eligibility Criteria

Frequently asked questions about FT-003

What is FT-003 used for?

FT-003 is an investigational gene therapy being developed for the treatment of diabetic macular edema, a condition that causes vision loss in people with diabetes. It is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.

Who is developing FT-003?

FT-003 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research on this gene therapy candidate for diabetic macular edema.

What phase is FT-003 in?

FT-003 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The ongoing Phase 1 trial is actively recruiting participants to evaluate the therapy.

What clinical trials is FT-003 in?

FT-003 is being studied in a Phase 1 clinical trial registered as NCT05916391, titled 'Gene Therapy for Diabetic Macular Edema.' This trial is recruiting 18 participants in China and is open to adults aged 18 years and older of all sexes.

How does FT-003 work?

FT-003 is a gene therapy designed to treat diabetic macular edema. While the specific molecular target has not been disclosed, gene therapies typically work by delivering genetic material to cells to produce a therapeutic protein or correct a genetic defect. The exact mechanism of action for FT-003 is not publicly detailed.