RECRUITINGPhase 3INTERVENTIONAL
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration
About This Trial
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration
Who May Be Eligible (Plain English)
Who May Qualify:
- ≥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:
1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
2. 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 stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
- 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 (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
- 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
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion 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:
1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
2. 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 stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
* 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 (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
* 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
Exclusion Criteria:
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
Treatments Being Tested
BIOLOGICAL
4D-150 IVT (3E10 vg/eye)
If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1
BIOLOGICAL
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea (aflibercept) will be administered at applicable visits
Locations (20)
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States
Retina Associates
Tucson, Arizona, United States
Retinal Diagnostic Center
Campbell, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
West Coast Retina Medical Group
San Francisco, California, United States
Southwest Retina Consultants
Durango, Colorado, United States
ClearVista Clinical Research
Hudson, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
The Retina Care Center
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, United States
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States
Vitreoretinal Consultants of NY
Westbury, New York, United States
North Carolina Retina Associates
Cary, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Verum Research, LLC
Eugene, Oregon, United States
Charleston Neuroscience Institute, LLC
Bluffton, South Carolina, United States
Carolina Eyecare
Mt. Pleasant, South Carolina, United States
Tennessee Retina, PC
Nashville, Tennessee, United States