Health TrialsbyHealthPanel

Gene Therapy for Wet AMD

ConditionNeovascular Age-related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age45+
SponsorFrontera Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects that are willing and able to follow study procedures;

Female or male patients ≥45 years old at the time of signing the ICF;

Clinically diagnosed with nAMD;

Presence of active CNV

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • FT-003

    Genetic

    Administered via intraocular injection.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: FT003 Dose 1Experimental treatment 1 intervention
Group B: FT003 Dose 2Experimental treatment 1 intervention
Group C: FT003 Dose 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability after FT-003 injection

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

Time frame
At Week 52

Secondary outcomes

1

Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline

Time frame
At Week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Frontera Therapeutics

Lead sponsor

The First Affiliated Hospital of Soochow University

Collaborator

Tianjin Medical University Eye Hospital

Collaborator

Peking Union Medical College Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: