Health TrialsbyHealthPanel

4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration

ConditionNeovascular (Wet) Age-Related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
Sponsor4D Molecular Therapeutics

About this trial

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment.

Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

50 years of age

≥50 years of age

Diagnosed with CNV secondary to AMD (confirmed by reading center)

Study eye amenable to IVT injection

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • 4D-150 IVT

    Biological/Vaccine

    4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept

  • Aflibercept IVT

    Biological/Vaccine

    Commercially available Active Comparator Other Name: Eylea

Treatment groups

215 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: 4D-150 Dose Escalation up to 4 dose levelsExperimental treatment 1 intervention
Group B: 4D-150 Dose Expansion Dose 1Experimental treatment 1 intervention
Group C: 4D-150 Dose Expansion Dose 2Experimental treatment 1 intervention
Group D: 4D-150 Dose Expansion ControlActive comparator 1 intervention
Group E: 4D-150 Steroid OptimizationExperimental treatment 1 intervention
Group F: 4D-150 Population Extension Dose 1Experimental treatment 1 intervention
Group G: 4D-150 Population Extension Dose 2Experimental treatment 1 intervention
Group H: 4D-150 Population Extension Dose 3Experimental treatment 1 intervention
Group I: 4D-150 Contralateral Eye DoseExperimental treatment 1 intervention
Group J: 4D-150 Vector Shedding DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters

Time frame
52 weeks

Secondary outcomes

1

Time to receiving the first supplemental aflibercept injection

Time frame
52 weeks
2

Percentage of subjects requiring supplemental aflibercept injections over 52 weeks

Time frame
52 weeks
3

Number of supplemental aflibercept injections over 52 weeks

Time frame
52 weeks
4

Change from baseline in BCVA over time (up to 52 weeks) as assessed using the ETDRS Visual Acuity Chart

Time frame
52 weeks

Other outcomes

Sponsors and contacts

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

4D Molecular Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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