A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Conditions

Diabetic Macular Edema (DME)

Brief summary

The primary endpoint is mean change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letters score at Visit 12 (Week 52) compared with baseline.

Detailed description

The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy: • Area under the curve (AUC) of BCVA ETDRS letter changes across postbaseline visits up to Visit 12 (Week 52). • Mean change in central subfield thickness (CST) as measured by SD-OCT at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy:• Mean change in CST as measured by SD-OCT at each postbaseline visit compared with baseline.• Mean change in BCVA ETDRS letters score at each postbaseline visit compared with baseline. • The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at each postbaseline visit., Safety Endpoints: • Adverse events (AEs) • Intraocular pressure (IOP) • Hemoglobin A1c (HbA1c) • Lens clarity grading • Endothelial cell counts • Hematology • Serum chemistry • Blood pressure

Related papers

No related papers found yet.

Interventions

DRUGEye drops

DRUGsuspension

DRUGocular use

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is mean change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letters score at Visit 12 (Week 52) compared with baseline.	—

Secondary

Measure	Time frame
The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy: • Area under the curve (AUC) of BCVA ETDRS letter changes across postbaseline visits up to Visit 12 (Week 52). • Mean change in central subfield thickness (CST) as measured by SD-OCT at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy:• Mean change in CST as measured by SD-OCT at each postbaseline visit compared with baseline.• Mean change in BCVA ETDRS letters score at each postbaseline visit compared with baseline. • The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at each postbaseline visit., Safety Endpoints: • Adverse events (AEs) • Intraocular pressure (IOP) • Hemoglobin A1c (HbA1c) • Lens clarity grading • Endothelial cell counts • Hematology • Serum chemistry • Blood pressure	—

Measure

Time frame

The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy: • Area under the curve (AUC) of BCVA ETDRS letter changes across postbaseline visits up to Visit 12 (Week 52). • Mean change in central subfield thickness (CST) as measured by SD-OCT at Visit 12 (Week 52) compared with baseline., Other Secondary Efficacy:• Mean change in CST as measured by SD-OCT at each postbaseline visit compared with baseline.• Mean change in BCVA ETDRS letters score at each postbaseline visit compared with baseline. • The proportion of subjects with a 3-line or greater gain in BCVA assessed with the ETDRS scale at each postbaseline visit., Safety Endpoints: • Adverse events (AEs) • Intraocular pressure (IOP) • Hemoglobin A1c (HbA1c) • Lens clarity grading • Endothelial cell counts • Hematology • Serum chemistry • Blood pressure

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Countries

Bulgaria, Czechia, France, Germany, Italy, Spain

Outcome results

None listed