Health Condition 1: H578- Other specified disorders of eye and adnexa Health Condition 2: null- patients �18 years of age with either type 1 or 2 controlled diabetes mellitus and visual impairment due to diabetic macular edema
Conditions
Interventions
Intervention1: Brolucizumab 6 mg: Administered intravenously
treatment consist of 5 loading dose at 6 weekly interval followed by treatment ranging from frequency of 8 to 12 weekly interval
treatment duration is 2 years,
Control Intervention1: Aflibercept 2 mg: Administered intravenously, treatment consists of 5 loading dose at frequency of 4 week interval followed by injection at 8 we
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients must give written informed consent before any study related assessments are performed 2. Patients ââ?°Â¥18 years of age at baseline 3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ââ?°Â¤10% at screening 4. 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 5. 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 ïâ??· DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ââ?°Â¥340 Ã?¼m 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.
Exclusion criteria
Exclusion criteria: Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye 2. Active proliferative diabetic retinopathy in the study eye as per the investigator 3. 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) 4. 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 5. 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 6. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to investigatorââ?¬•s judgment, at screening or baseline 7. Neovascularization of the iris in the study eye at screening or baseline 8. Evidence of vitreomacular traction in the study eye at screening or baseline which, in the opinion of the investigator, affect visual acuity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the visual outcomeTimepoint: after the first year of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To study: Brolucizumab (RTH258) is non-inferior to aflibercept (Eylea) wrt visual outcome in last 3 months of first year.Potential to extend treatment intervals for RTH258 patients during the 2nd year of treatment.Functional & anatomical outcome with RTH258 relative to Eylea.Effect of RTH258 relative to Eylea on Diabetic Retinopathy status.Safety of RTH258 relative to Eylea.Effect of RTH258 relative to Eylea on patient reported outcomes (VFQ-25)Timepoint: End of the trial | — |
Countries
Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Latvia, Lebanon, Lithuania, Malaysia, Norway, Poland, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Turkey
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed