Status:
COMPLETED
To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.
Detailed Description
The study is a randomized, double-masked, multi-center, active-controlled, 2-arm study in Chinese patients with Diabetic macular edema (DME). Approximately 335 Chinese patients were planned to be scre...
Eligibility Criteria
Inclusion
- 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 months prior to randomization and is expected to remain as stable as medically acceptable during 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 Snellen equivalent 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 limiting membrane (ILM) inclusively) of ≥320 μm on Spectral domain optical coherence tomography (SD-OCT) at screening.
Exclusion
- Active Proliferative diabetic retinopathy (PDR) in the study eye as per investigator
- Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical 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, infectious blepharitis, uveitis) in study eye at screening or baseline
- Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema (ME), including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg 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 which in the opinion of the investigator, affects visual acuity
- Previous treatment with any anti-vascular growth factor (VEGF) drug or investigational drugs in the study eye
Key Trial Info
Start Date :
August 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04058067
Start Date
August 23 2019
End Date
January 31 2023
Last Update
October 9 2024
Active Locations (24)
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1
Novartis Investigative Site
Guangzhou, Guangdong, China, 510060
2
Novartis Investigative Site
Shantou, Guangdong, China, 515041
3
Novartis Investigative Site
Harbin, Heilongjiang, China, 150001
4
Novartis Investigative Site
Wuhan, Hubei, China, 430070