A Phase 2 Multicentric Randomized Double-Blinded Efficacy and Safety Clinical Trial Comparing Several Doses of Aganirsen Eye Drops Emulsion to Extend Intravitreal Aflibercept Treatment Interval in Wet Age-Related Macular Degeneration (wAMD) Patients - SKY2 Study

Condition studied

Wet Age-Related Macular Degeneration (wAMD) Patients

Investigational medicinal product(s)

Every trial of Aflibercept across our registers →

Eligibility

Primary endpoint

Percentage of participants who have successfully extended their intravitreal aflibercept 8 mg treatment interval by at least 2 weeks between baseline and 9 months

Endpoint detail

Change in Best Corrected Visual Acuity (BCVA) from baseline to 9 months, assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, Number of weeks between the last successful intravitreal aflibercept 8 mg treatment interval at 9 months and the baseline interval, Number of intravitreal aflibercept 8 mg injections from baseline to 9 months, Change in central macular thickness from baseline to 9 months, assessed using OCT, Percentage of participants with absence of retinal fluid (i.e., absence of IRF and SRF) at 9 months, assessed using OCT, Incidence and nature of AEs over the 9 months and 1 week follow-up period, Incidence and grading, according to a Visual Analog Scale (VAS), of local tolerance events over the 9-month treatment period, Change in safety blood markers from baseline to 9 months, Change in conjunctival hyperemia score from baseline to 9 months, Change in corneal staining score from baseline to 9 months, Change in IntraOcular Pressure (IOP) from baseline to 9 months, Change in Tear Break-Up Time (TBUT) from baseline to 9 months