Phase
Condition
Macular Degeneration
Diabetic Retinopathy
Geographic Atrophy
Treatment
4D-150 IVT (3E10 vg/eye)
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥50 years of age at time of consent
MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, definedas 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 andreceived diagnosis of nAMD no more than 6 months prior to the Screening VisitAND documented evidence of anatomical improvement and visualstability/improvement in response to previous IVT anti-VEGF treatment, asdetermined by the Investigator
Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflectivematerial, or leakage) identified by fluorescein angiography (FA) or spectral domainoptical coherence tomography (SD-OCT) , in the study eye, at the Screening Visitconfirmed by the Reading Center
Demonstrated clinical response to aflibercept and functional stability in the studyeye as confirmed by the Reading Center
BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) inthe study eye at the Screening Visit
CST less than or equal to 500 microns in the study eye at screening visit, confirmedby the central reading center
Exclusion
Exclusion Criteria:
Ocular Conditions:
MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinalhemorrhage 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 forcontrol
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 ScreeningVisit
Uncontrolled blood pressure
Acute coronary syndrome, myocardial infarction or coronary artery revascularization,cerebrovascular accident, transient ischemic attack within 6 months of the ScreeningVisit
History of autoimmune condition that may predispose to the development of uveitis
Study Design
Connect with a study center
Barnet Dulaney Perkins Eye Center
Sun City, Arizona 85351
United StatesActive - Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Tennessee Retina, PC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.