Phase
Condition
Eye Disorders/infections
Diabetic Retinopathy
Diabetic Macular Edema
Treatment
Brolucizumab
Aflibercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Patients ≥18 years of age at screening
Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) of ≤10% at screening
Medication for the management of diabetes must have been stable within 3 monthsprior to randomization and is expected to remain as stable as medically acceptableduring the course of the study
Study Eye Visual impairment due to diabetic macular edema (DME) with:
Best-corrected visual acuity (BCVA) score between 78 and 23 letters, inclusive,using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA)testing charts at a starting testing distance of 4 meters (approximate Snellenequivalent of 20/32 to 20/320) at screening and baseline
DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limitingmembrane (ILM) inclusively) of ≥320 μm on Spectral domain optical coherencetomography (SD-OCT) at screening.
Exclusion
Exclusion Criteria:
Active Proliferative diabetic retinopathy (PDR) in the study eye as per investigator
Concomitant conditions or ocular disorders in the study eye at screening or baselinewhich could, in the opinion of the investigator, prevent response to study treatmentor may confound interpretation of study results, compromise visual acuity or requiremedical or surgical intervention for the duration of the study (e.g. cataract,vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole,or choroidal neovascularization (CNV) of any cause)
Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectiousblepharitis, uveitis) in study eye at screening or baseline
Structural damage of the fovea in the study eye at screening likely to precludeimprovement in visual acuity following the resolution of macular edema (ME),including atrophy of the retinal pigment epithelium, subretinal fibrosis, laserscar(s), epiretinal membrane involving fovea or organized hard exudate plaques
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25mmHg on medication or according to investigator's judgment at Screening or Baseline
Neovascularization of the iris in the study eye at screening or baseline
Evidence of vitreomacular traction in the study eye at screening or baseline whichin the opinion of the investigator, affects visual acuity
Previous treatment with any anti-vascular growth factor (VEGF) drug orinvestigational drugs in the study eye
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Guangzhou, Guangdong 510060
ChinaSite Not Available
Novartis Investigative Site
Shantou, Guangdong 515041
ChinaSite Not Available
Novartis Investigative Site
Harbin, Heilongjiang 150001
ChinaSite Not Available
Novartis Investigative Site
Wuhan, Hubei 430070
ChinaSite Not Available
Novartis Investigative Site
Wuxi, Jiangsu 214002
ChinaSite Not Available
Novartis Investigative Site
Changchun City, Jilin 130041
ChinaSite Not Available
Novartis Investigative Site
Qingdao, Shandong 2666000
ChinaSite Not Available
Novartis Investigative Site
Chengdu, Sichuan 610041
ChinaSite Not Available
Novartis Investigative Site
Tianjin, Tianjin 300070
ChinaSite Not Available
Novartis Investigative Site
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Novartis Investigative Site
Wenzhou, Zhejiang 325027
ChinaSite Not Available
Novartis Investigative Site
Beijing, 100730
ChinaSite Not Available
Novartis Investigative Site
Chongqing, 400042
ChinaSite Not Available
Novartis Investigative Site
Nanjing, 210036
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200031
ChinaSite Not Available
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