The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
592
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
Time frame: Day1 (Baseline) and Month 5 (Day150)
VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible
Time frame: Day1/Baseline and Day150/Month 5
VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
Time frame: Day1/Baseline and Day150/Month 5
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Unnamed facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Mountain View, California, United States
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Sacramento, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
...and 141 more locations