The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).
This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis® or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
582
Intravitreal injection
Change in Best Corrected Visual Acuity (BCVA)
Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol
Time frame: Baseline and Week 8
Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye
Change in the total size of choroidal neovascular leakage area in the study eye week 52 compared to baseline measured by Fluorescein Angiography
Time frame: Baseline and Week 52
Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye
Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye Measured by Fluorescein Angiography
Time frame: Baseline and week 52
Central Foveal Thickness in the Study Eye
Central Foveal Thickness in the Study Eye Measured by Optical Coherence Tomography
Time frame: Baseline to week 52
Percentage of Subjects With Loss of <15 BCVA Letters
Percentage of Subjects With Loss of \<15 BCVA Letters Compared to Baseline in the Study Eye
Time frame: Baseline to week 52
Percentage of Subjects With Gain of ≥15 BCVA Letters
Percentage of Subjects With Gain of ≥15 BCVA Letters Compared to Baseline in the Study Eye
Time frame: Baseline to week 52
Subretinal Fluid in the Study Eye
Change from Baseline in the Amount of Subretinal Fluid in the Study Eye Measured by OCT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retinal Research Institute, LLC
Gilbert, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Retina Centers P.C
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
The Retina Partners
Encino, California, United States
Mark B. Kislinger MD Inc.
Glendora, California, United States
Retina Consultants Medical Group Inc.
Sacramento, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Fort Lauderdale Eye Institute
Fort Lauderdale, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
...and 92 more locations
Time frame: Baseline to week 52
Width of Retinal Pigment Epithelium Detachments in the Study Eye
Change from Baseline in the Width of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT
Time frame: Baseline to Week 52
Pharmacokinetic Plasma Ranibizumab Concentrations
Pharmacokinetic Plasma Ranibizumab Concentrations (sub-study)
Time frame: Day 1 to week 20
Height of Retinal Pigment Epithelium Detachments
Change from Baseline in the Height of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT
Time frame: Baseline to Week 52