Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Dia… (NCT04079231) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Stopped: This study was cancelled due to COVID-19.
0Started 2021-02-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Who can participate
Age range18 Years – 110 Years
SexALL
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Inclusion Criteria:
* Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at Screening
* BCVA score between 23 and 65 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline
* DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥ 320 µm on SD-OCT
Exclusion Criteria:
* High risk or advanced proliferative diabetic retinopathy in the study eye as per reading Center
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
* Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye in the last 3 months prior randomization
* Stroke or myocardial infarction during the 6-month period prior to baseline
* Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg Other protocol-specified inclusion/exclusion criteria may apply
What they're measuring
1
Proportion of patients with a gain in Best Corrected Visual Acurity (BCVA) of ≥15 ETDRS letters at week 48