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Clinical Trials in the USA / NCT05197270
Recruiting Phase 1/2

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

NCT05197270 · tracked via the Priya Life Science USA tracker
Sponsor
4D Molecular Therapeutics
Phase
Phase 1/2
Started
2021-12-09
Last updated
2026-08-21

Condition(s) studied

Neovascular (Wet) Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

4D-150 IVTAflibercept IVT

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

Study summary

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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
* 50 years of age Individuals eligible to participate in the trial must meet the following inclusion criteria: 1. ≥50 years of age 2. Diagnosed with CNV secondary to AMD (confirmed by reading center) 3. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye: 4. Central subfield thickness (CST) and/or presence of subretinal or intraretinal fluid requiring continued anti-VEGF therapy in the study eye, as assessed by SD-OCT; and confirmed by a reading center): 5. Study eye amenable to IVT injection 6. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures 7. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye AND has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening: Note: Day -7 aflibercept will be administered ≥ 4 weeks from last IVT anti-VEGF 8. Subjects receiving 4D-150 agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Medical records available to document history of anti-VEGF therapy (dates, drugs, and dosage) for a minimum of 12 months prior to Screening 10. Provide written informed consent. Contralateral Eye Sub-study-Specific Criteria: 1. Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Substudy Screening Visit NOTE: Subjects who received 4D-150 in study eye-1 as part of the Shedding Substudy are also eligible to participate in the Contralateral Eye Substudy only after biological samples from all matrices were at or below the limit of quantitation for vector genomes in at least 3 consecutive measurements AND at least 6 months has passed since 4D-150 administration to study eye-1. 2. Macular neovascularization (MNV) secondary to AMD in study eye-2 as assessed on historical images at any time by SD-OCT (required) and FA when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by the reading center) 3. History of at least 1 anti-VEGF injection in study eye-2 within 6 months prior to Screening (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time point prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 4. BCVA between 25 and 83 ETDRS letters, inclusive (20/320 20/25 Snellen) in study eye-2 5. Study eye-2 amenable to IVT injection 6. BCVA ≥34 ETDRS letters (\~20/200) in the previously treated study eye-1 7. Ability to comply with protocol-specified procedures and visits, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to study eye-2 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent. Shedding Substudy-specific Inclusion Criteria: 1. ≥50 years of age 2. Diagnosed with MNV secondary to AMD as assessed on historical images at any time by spectral domain optical coherence tomography (SD-OCT) (required) and fluorescein angiography when available or fundus photography when available or at screening based on SD-OCT, FA and fundus photography (confirmed by Reading Center) 3. Best corrected visual acuity (BCVA) between 10 and 83 ETDRS letters, inclusive (\~20/640 and 20/25, respectively) in the study eye at Screening 4. BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye 5. Currently receiving anti-VEGF treatment (e.g. ranibizumab, aflibercept, faricimab or bevacizumab) in the study eye; minimum of 1 injection within the last 6 months (last anti-VEGF injection must be at least 28 days prior to Day 7) AND has demonstrated a clinical response consistent with anti-VEGF activity by historical OCT at any time prior to screening with confirmed response by the reading center (Screening OCT can be confirmatory) 6. Study eye amenable to IVT injection 7. Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures, in the Investigator's judgment 8. Agree to use a barrier method (e.g. condom) during intercourse for 6 months after administration of 4D-150 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period 9. Provide written informed consent.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Barnet Delaney Perkins Eye Center Phoenix Arizona Recruiting
California Retina Consultants Oxnard California Recruiting
Retinal Consultants Medical Group Sacramento California Recruiting
Colorado Retina Associates Lakewood Colorado Recruiting
Rand Eye Institute Deerfield Beach Florida Suspended
Retina Group of Florida Fort Lauderdale Florida Recruiting
Retina Vitreous Consultants, LLP DBA Retina Group of Florida Fort Lauderdale Florida Active Not Recruiting
Vitreo Retinal Associates Gainesville Florida Recruiting
Florida Eye Associates Melbourne Florida Recruiting
Retinal Specialty Institute Pensacola Florida Recruiting
Retina Vitreous Associates of Florida Tampa Florida Recruiting
University Retina and Macula Associates Oak Forest Illinois Recruiting
Retina Partners Midwest Carmel Indiana Recruiting
Cumberland Valley Retina Consultants Hagerstown Maryland Recruiting
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center Boston Massachusetts Recruiting
Sierra Eye Associates Reno Nevada Recruiting
Western Carolina Retinal Associates Asheville North Carolina Withdrawn
Verum Research, LLC Eugene Oregon Recruiting
Mid Atlantic Retina Bethlehem Pennsylvania Recruiting
Palmetto Retina Center, LLC West Columbia South Carolina Recruiting
Tennessee Retina Nashville Tennessee Recruiting
Austin Clinical Research Austin Texas Recruiting
Valley Retina Institute, PA McAllen Texas Recruiting
Retina Consultants of Texas The Woodlands Texas Withdrawn
Pacific Northwest Retina LLC Bellevue Washington Withdrawn
Emanuelli Research and Development Center, LLC Arecibo Puerto Rico Recruiting

More 4D Molecular Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197270 on ClinicalTrials.gov ↗ ← All trials in the USA