4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
NCT ID: NCT05197270
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
215 participants
INTERVENTIONAL
2021-12-09
2031-01-31
Brief Summary
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Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.
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Detailed Description
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After receiving one time administration of 4D-150 by intravitreal injection (IVT), 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).
Eligible subjects who received 4D-150 in the study eye may participate in a sub-study to evaluate one time IVT administration of 4D-150 to the contralateral ("fellow") eye.
Additional subjects will be enrolled in a separate sub-study to characterize the vector shedding profile of one time administration of IVT 4D-150.
In both sub-studies, subjects will undergo regular assessments to assess safety and tolerability through Week 52 and then will enter long-term follow-up for safety evaluation through year 5 (60 months).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Contralateral sub-study: Up to 20 subjects from the 4D-150-C001 trial who have previously received 4D-150 in study eye-1 will be enrolled and administered a single open-label IVT injection of 4D-150 in the contralateral eye.
Vector Shedding sub-study: Approximately 15 subjects will receive an open-label IVT injection of 4D-150 to evaluate vector shedding.
TREATMENT
SINGLE
Study Groups
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4D-150 Dose Escalation up to 4 dose levels
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Dose Expansion Dose 1
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Dose Expansion Dose 2
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Dose Expansion Control
Aflibercept at a fixed regimen will be administered.
Aflibercept IVT
Commercially available Active Comparator Other Name: Eylea
4D-150 Steroid Optimization
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Population Extension Dose 1
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Population Extension Dose 2
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Population Extension Dose 3
4D-150 will be administered at the assigned dose
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Contralateral Eye Dose
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
4D-150 Vector Shedding Dose
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
50 Years
ALL
No
Sponsors
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4D Molecular Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia Isabell Manalastas, MD
Role: STUDY_DIRECTOR
4D Molecular Therapeutics
Locations
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Barnet Delaney Perkins Eye Center
Phoenix, Arizona, United States
California Retina Consultants
Oxnard, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Vitreo Retinal Associates
Gainesville, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retinal Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
University Retina and Macula Associates
Oak Forest, Illinois, United States
Retina Partners Midwest
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
Boston, Massachusetts, United States
Sierra Eye Associates
Reno, Nevada, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Verum Research, LLC
Eugene, Oregon, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Clinical Research
Austin, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Pacific Northwest Retina LLC
Bellevue, Washington, United States
Emanuelli Research and Development Center, LLC
Arecibo, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4D-150-C001
Identifier Type: -
Identifier Source: org_study_id
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