Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
3 intravitreal injections of THR-149 dose level 1, 1 month apart
3 intravitreal injections of THR-149 dose level 2, 1 month apart
3 intravitreal injections of THR-149 dose level 3, 1 month apart
Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study
Time frame: At Month 3
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Time frame: Up to Month 6
Mean change in central subfield thickness (CST) from Baseline, by study visit
Time frame: Up to Month 6
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Month 6
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3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retina Associates
Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Salehi Retina Institute Inc.
Huntington Beach, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, United States
California Retina Consultants
Oxnard, California, United States
Retina Consultants San Diego
Poway, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
...and 68 more locations