Status:
COMPLETED
A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in 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
This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibe...
Detailed Description
The study included a screening period of up to 2 weeks to assess eligibility, followed by a double-masked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end ...
Eligibility Criteria
Inclusion
- Key
- General
- Patients must give written informed consent before any study related assessments are performed
- Patients with type 1 or type 2 diabetes mellitus and 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 stable during the course of the study
- Study Eye
- Visual impairment due to DME with:
- BCVA score between 78 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a 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 (measured from RPE to ILM inclusively) of \>= 320 micrometers (μm) on SD-OCT at screening If both eyes are eligible, the eye with the worse visual acuity will be selected for study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements.
- Key
Exclusion
- Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye
- Active proliferative diabetic retinopathy in the study eye as per the 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 during the first 12-month study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization 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, 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 millimeters mercury (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, affect visual acuity
Key Trial Info
Start Date :
July 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03481660
Start Date
July 27 2018
End Date
June 8 2021
Last Update
January 7 2025
Active Locations (78)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Alken, Belgium, 3570
2
Novartis Investigative Site
Sofia, Bulgaria, 1606
3
Novartis Investigative Site
Sofia, Bulgaria, 1784
4
Novartis Investigative Site
Varna, Bulgaria, 9000