The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
100microgram single intravitreal injection
200microgram single intravitreal injection
400microgram single intravitreal injection
800microgram single intravitreal injection
1200microgram single intravitreal injection
1600microgram single intravitreal injection
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Cleveland, Ohio, United States
Adverse Events
Time frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84
Visual Acuity using the Diabetic Retinopathy Study chart
Time frame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
IOP
Time frame: Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
OCT
Time frame: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
Fluorescein Angiography (FA)
Time frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)
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