To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
Retina Research Institute
Gilbert, Arizona, United States
Retina-Vitreous Associates
Beverly Hills, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 24
BCVA is the primary efficacy variable for this study, and mean change from baseline in BCVA at Week 24 is the primary efficacy endpoint. An increase in the number of letters read correctly means that vision has improved.The lower the number of letters read correctly on the eye chart, the worse the vision.
Time frame: Week 24
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Bay Area Retina Associates
Walnut Creek, California, United States
Colorado Retina Associates
Golden, Colorado, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Reseach Center
Austin, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Valley Retina Insititute
McAllen, Texas, United States
...and 4 more locations