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The trial is taking place at:
A

Austin Retina Associates | Main | Austin, TX

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

4

4D Molecular Therapeutics (4DMT)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Neovascular (Wet) Age-Related Macular Degeneration

Treatments

Biological: Aflibercept IVT
Biological: 4D-150 IVT

Study type

Interventional

Funder types

Industry

Identifiers

NCT05197270
4D-150-C001

Details and patient eligibility

About

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

Full description

This Phase 1/2 trial is a prospective, multicenter, Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment who have demonstrated a clinical response consistent with anti-VEGF activity. The trial consists of Dose Escalation, Dose Expansion, Steroid Optimization and Population Extension Cohorts.

After receiving one time administration of 4D-150 by intravitreal injection, subjects will undergo assessments at monthly intervals for 24 months to assess safety and efficacy outcomes. Only subjects that received 4D-150 will then enter a long-term follow-up (LTFU) period to assess long-term safety of 4D-150 gene therapy and duration of clinical activity through year 5 (60 months).

Enrollment

150 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥50 years of age
  • Diagnosed with macular CNV secondary to AMD
  • BCVA ETDRS Snellen equivalent for dose escalation between ~20/32 and ~20/320, or for dose expansion and population extension between ~20/25 and~20/200, for steroid optimization between ~20/25 and ~20/640
  • Currently receiving anti-VEGF treatment in the study eye and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening

Exclusion criteria

  • Any condition preventing visual acuity improvement in the study eye
  • Prior treatment with photodynamic therapy or retinal laser in the study eye
  • History of uveitis in either eye
  • Any other pre-existing eye conditions or surgical complications that would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

150 participants in 7 patient groups

4D-150 Dose Escalation up to 4 dose levels
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT
4D-150 Dose Expansion Dose 1
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT
4D-150 Dose Expansion Dose 2
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT
4D-150 Dose Expansion Control
Active Comparator group
Description:
Aflibercept at a fixed regimen will be administered.
Treatment:
Biological: Aflibercept IVT
4D-150 Steroid Optimization
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT
4D-150 Population Extension Dose 1
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT
4D-150 Population Extension Dose 2
Experimental group
Description:
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Treatment:
Biological: 4D-150 IVT

Trial contacts and locations

26

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Central trial contact

4DMT Patient Advocacy

Data sourced from clinicaltrials.gov

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