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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526775-27-00
Enrollment
162
Registered
2026-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-Related Macular Degeneration (wAMD) Patients

Brief summary

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

Detailed description

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

Interventions

DRUGEylea 114.3 mg/ml solution for injection in pre-filled syringe
DRUGPlacebo

Sponsors

Laboratoires Kol
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 11, 2026