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

Neovascular (Wet) Age-Related Macular Degeneration Clinical Trial

Official title:

A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults With Neovascular (Wet) Age-Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197270
• Other study ID #: 4D-150-C001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 9, 2021
• Est. completion date: November 2025

Study information

• Verified date: August 2023
• Source: 4D Molecular Therapeutics
• Contact: 4DMT Patient Advocacy
• Phone: (888) 748-8881
• Email: clinicaltrials[@]4DMT.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular (Wet) Age-Related Macular Degeneration

Intervention

Biological:
• 4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
• Aflibercept IVT
Commercially available Active Comparator Other Name: Eylea

Locations

Country	Name	City	State
Puerto Rico	Emanuelli Research and Development Center, LLC	Arecibo
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	Austin Clinical Research	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Pacific Northwest Retina LLC	Bellevue	Washington
United States	Mid Atlantic Retina	Bethlehem	Pennsylvania
United States	Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center	Boston	Massachusetts
United States	Retina Partners Midwest	Carmel	Indiana
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	Verum Research, LLC	Eugene	Oregon
United States	Vitreo Retinal Associates	Gainesville	Florida
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Retina Consultants of Texas	Houston	Texas
United States	Colorado Retina Associates	Lakewood	Colorado
United States	Valley Retina Institute, PA	McAllen	Texas
United States	Florida Eye Associates	Melbourne	Florida
United States	Tennessee Retina	Nashville	Tennessee
United States	University Retina and Macula Associates	Oak Forest	Illinois
United States	California Retina Consultants	Oxnard	California
United States	Retinal Specialty Institute	Pensacola	Florida
United States	Barnet Delaney Perkins Eye Center	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retina Vitreous Associates of Florida	Tampa	Florida
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Palmetto Retina Center, LLC	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
4D Molecular Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters		52 weeks
Secondary	Time to receiving the first supplemental aflibercept injection		52 weeks
Secondary	Percentage of subjects requiring supplemental aflibercept injections over 52 weeks		52 weeks
Secondary	Number of supplemental aflibercept injections over 52 weeks		52 weeks
Secondary	Change from baseline in BCVA over time (up to 52 weeks) as assessed using the ETDRS Visual Acuity Chart		52 weeks
Secondary	Change from baseline in central subfield thickness (CST) over time (up to 52 weeks) measured by spectral domain optical coherence tomography (SD-OCT)		52 weeks