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New treatment option for Neovascular Age-Related Macular Degeneration (nAMD)
Official title Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT07064759
What this study is testing
What is 4D-150 IVT (3E10 vg/eye)?
4D-150 IVT (3E10 vg/eye) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration (namd).
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
- A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
- Phase 3: a large, late-stage study
- 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 at time of consent
- MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
- Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
- Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the...
- Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal...
You likely can't join if
- Ocular Conditions:
- MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
- History of retinal detachment in the study eye
- History of or presence of active inflammation in either eye
- Glaucoma or intraocular hypertension requiring more than 2 topical medications for control Ocular Treatments/Interventions:
- Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye Systemic...
See the full eligibility criteria
- ≥50 years of age at time of consent
- MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
- Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
- Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual...
- Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography...
- Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
- BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
- CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center
- Ocular Conditions:
- MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
- History of retinal detachment in the study eye
- History of or presence of active inflammation in either eye
- Glaucoma or intraocular hypertension requiring more than 2 topical medications for control Ocular Treatments/Interventions:
- Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye Systemic Conditions and Considerations:
- Major illness or major surgical procedure in the 28 days prior to the Screening Visit
- Uncontrolled blood pressure
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
- History of autoimmune condition that may predispose to the development of uveitis
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Campbell, California, United States
- Fullerton, California, United States
- Mountain View, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Durango, Colorado, United States
- Hudson, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- St. Petersburg, Florida, United States
- Stuart, Florida, United States
- Tampa, Florida, United States
- Sandy Springs, Georgia, United States
- Elmhurst, Illinois, United States
- Oak Forest, Illinois, United States
+ 64 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 Scottsdale, Arizona, United States; Sun City, Arizona, United States; Tucson, Arizona, United States; Campbell, California, United States; Fullerton, California, United States; Mountain View, California, United States and 78 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.