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New treatment option for Neovascular (Wet) Age-Related Macular Degeneration
Official title 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT05197270
What this study is testing
What is 4D-150 IVT?
4D-150 IVT is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for neovascular (wet) age-related macular degeneration.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 50 years of age Individuals eligible to participate in the trial must meet the following
- ≥50 years of age
- Diagnosed with CNV secondary to AMD (confirmed by reading center)
- BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye:
- Central subfield thickness (CST) and/or presence of subretinal or intraretinal fluid requiring continued anti-VEGF therapy in the study eye, as...
See the full eligibility criteria
- 50 years of age Individuals eligible to participate in the trial must meet the following
- ≥50 years of age
- Diagnosed with CNV secondary to AMD (confirmed by reading center)
- BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye, and BCVA in the study eye:
- 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):
- Study eye amenable to IVT injection
- Ability to perform tests of visual and retinal function and structure, and ability to comply with other protocol-specified procedures
- 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...
- people 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...
- Medical records available to document history of anti-VEGF therapy (dates, drugs, and dosage) for a minimum of 12 months prior to Screening
- Provide written informed consent. Contralateral Eye Sub-study-Specific Criteria:
- Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Substudy Screening Visit NOTE: people who received 4D-150 in study eye-1 as part of the Shedding Substudy are also eligible to participate in the...
- 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...
- 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 Screening) AND has demonstrated a clinical response consistent with...
- BCVA between 25 and 83 ETDRS letters, inclusive (20/320 20/25 Snellen) in study eye-2
- Study eye-2 amenable to IVT injection
- BCVA ≥34 ETDRS letters (\~20/200) in the previously treated study eye-1
- Ability to comply with protocol-specified procedures and visits, in the Investigator's judgment
- 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...
- Provide written informed consent. Shedding Substudy-specific
- ≥50 years of age
- 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...
- Best corrected visual acuity (BCVA) between 10 and 83 ETDRS letters, inclusive (\~20/640 and 20/25, respectively) in the study eye at Screening
- BCVA ≥34 ETDRS letters (\~20/200) in the contralateral eye
- 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...
- Study eye amenable to IVT injection
- 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
- 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
- Provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Oxnard, California, United States
- Sacramento, California, United States
- Lakewood, Colorado, United States
- Deerfield Beach, Florida, United States
- Fort Lauderdale, Florida, United States
- Gainesville, Florida, United States
- Melbourne, Florida, United States
- Pensacola, Florida, United States
- Tampa, Florida, United States
- Oak Forest, Illinois, United States
- Carmel, Indiana, United States
- Hagerstown, Maryland, United States
- Boston, Massachusetts, United States
- Reno, Nevada, United States
- Asheville, North Carolina, United States
- Eugene, Oregon, United States
- Bethlehem, Pennsylvania, United States
- West Columbia, South Carolina, United States
- Nashville, Tennessee, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Oxnard, California, United States; Sacramento, California, United States; Lakewood, Colorado, United States; Deerfield Beach, Florida, United States; Fort Lauderdale, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.