diabetic macular edema
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General - Patients must give written informed consent before any study related assessments are performed - Patients =18 years of age at baseline - 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: o BCVA score between 23 and 65 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/50 to 20/320), at screening and baseline o DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of = 320 µm on SDOCT 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. Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 178 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 178
Exclusion criteria
Exclusion criteria: 1. High-risk proliferative diabetic retinopathy (PDR) in the study eye as per central reading center assessment at screening 2. 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) 3. 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 4. 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 5. 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 6. Neovascularization of the iris in the study eye at screening or baseline 7. Evidence of vitreomacular traction in the study eye at screening or baseline which in the opinion of the investigator, affects visual acuity Ocular treatments: 8. Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye 9. Use of dexamethasone intravitreal implant (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time. Prior use of other intraocular or periocular corticosteroids in the study eye is not an exclusion provided at least 6-month wash-out prior to baseline 10. Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 month period prior to baseline 11. Intraocular surgery including YAG laser in the study eye during the 3 month period prior to baseline 12. History of vitreoretinal surgery in study eye 13. Aphakia with the absence of posterior capsule in the study eye Systemic treatments: 14. Stroke or myocardial infarction during the 6-month period prior to baseline 15. Renal failure requiring dialysis or renal transplant 16. Uncontrolled blood pressure defined as a systolic value =160 mmHg or diastolic value =100 mmHg at screening or baseline 17. Untreated diabetes mellitus Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: - To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the visual outcome after 52 weeks of treatment;Secondary Objective: -To demonstrate that brolucizumab is non-inferior to aflibercept with respect to visual acuity outcome during the last 3 months - To estimate the predictive value of the first q12w cycle for maintenance of q12w treatment with brolucizumab - To evaluate the functional and anatomical outcome with brolucizumab relative to aflibercept - To evaluate the effect of brolucizumab relative to aflibercept on the Diabetic Retinopathy status - To assess the safety of brolucizumab relative to aflibercept - To evaluate the effect of brolucizumab relative to aflibercept on patient-reported outcomes (VFQ-25);Primary end point(s): Primary: Mean change in BCVA from baseline to Week 52;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in BCVA averaged over a period from Week 40 to Week 52 - Proportion of patients maintained at q12w up to Week 52, within those patients that qualified for q12w at Week 32 - Change from baseline up to Week 52 in BCVA and in Parameters derived from SD-OCT, Color fundus photography and Fluorescein angiography - Change in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score up to Week 52 - Incidence of Ocular and Non-ocular AEs, and vital signs up to Week 52 - Change in patient reported outcomes (VFQ-25) total and subscale scores from baseline up to Week 52;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoserivce (MCC)
Novartis Pharma GmbH
Outcome results
None listed