The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
Intravitreal injection of hI-con1 0.3 mg
Intravitreal injection of ranibizumab 0.5 mg
No injection is given, a needleless syringe is used to mimic an injection.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Time frame: Baseline and Month 3
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.
Time frame: Baseline and Month 3
Change From Baseline in BCVA in the Study Eye at Month 6
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Time frame: Baseline and Month 6
Change From Baseline in CST in the Study Eye at Month 6
Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.
Time frame: Baseline and Month 6
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Glendale, California, United States
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Laguna Hills, California, United States
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Mountain View, California, United States
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Palm Desert, California, United States
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Palo Alto, California, United States
...and 38 more locations