4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
About this trial
This is an interventional treatment trial for Neovascular (Wet) Age-Related Macular Degeneration focused on measuring Age-related macular degeneration, AMD, Exudative AMD, Exudative age-related macular degeneration, Neovascular AMD, Neovascular age-related macular degeneration, Wet age-related macular degeneration, Wet macular degeneration, Wet AMD, wAMD, Retinal gene therapy, Intravitreal gene therapy
Eligibility Criteria
Inclusion Criteria:
- ≥50 years of age
- Diagnosed with CNV secondary to AMD
- BCVA ETDRS Snellen equivalent for dose escalation between ~20/50 and ~20/320 (sentinel subjects only) or ~20/32 and ~20/320, or for dose expansion ~20/25 and~20/200
- Currently receiving anti-VEGF treatment in the study eye (minimum of 6 injections within the last 12 months) and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening
Exclusion Criteria:
- Fibrosis, atrophy, or retinal pigment epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
- Prior treatment with photodynamic therapy or retinal laser
- History of uveitis in either eye
- Any other pre-existing eye conditions or surgical complications that would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints
Sites / Locations
- Barnet Delaney Perkins Eye CenterRecruiting
- California Retina ConsultantsRecruiting
- Retinal Consultants Medical GroupRecruiting
- Colorado Retina AssociatesRecruiting
- Rand Eye InstituteRecruiting
- Vitreo Retinal AssociatesRecruiting
- Florida Eye AssociatesRecruiting
- Retinal Specialty InstituteRecruiting
- Retina Vitreous Associates of FloridaRecruiting
- University Retina and Macula AssociatesRecruiting
- Retina Partners MidwestRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser CenterRecruiting
- Sierra Eye AssociatesRecruiting
- Western Carolina Retinal AssociatesRecruiting
- Verum Research, LLCRecruiting
- Mid Atlantic RetinaRecruiting
- Palmetto Retina Center, LLCRecruiting
- Tennessee RetinaRecruiting
- Austin Retina Associates
- Austin Clinical ResearchRecruiting
- Retina Consultants of TexasRecruiting
- Valley Retina Institute, PARecruiting
- Retina Consultants of TexasRecruiting
- Pacific Northwest Retina LLCRecruiting
- Emanuelli Research and Development Center, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
4D-150 Dose Escalation up to 4 dose levels
4D-150 Dose Expansion Dose 1
4D-150 Dose Expansion Dose 2
4D-150 Dose Expansion Control
4D-150 Steroid Optimization
4D-150 Population Extension Dose 1
4D-150 Population Extension Dose 2
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Aflibercept at a fixed regimen will be administered.
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.