Study Assessing the effect of Brolucizumab versus Aflibercept in Adult Patientswith Visual Damage related diabetes.
Phase 3
Completed
- Conditions
- Other specified disorders of eye and adnexa, patients ≥18 years of age with either type 1or 2 controlled diabetes mellitus and visual impairment due to diabeticmacular edema,
- Registration Number
- CTRI/2018/09/015622
- Lead Sponsor
- Novartis Healthcare Pvt Ltd
- Brief Summary
To evaluate the safety and efficacy of Brolucizumab in treatment of patients withy visual impairment due to diabetic macular edema.
FPFV for India-1st Sep 2018
Recruitment Target for India-40 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 356
Inclusion Criteria
- 1.Patients must give written informed consent before any study related assessments are performed 2.
- Patients ≥18 years of age at baseline 3.
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤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  DME involving the center of the macula, with central subfield retinal thickness (measured from RPE to ILM inclusively) of ≥340 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.
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 investigator’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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to the visual outcome after the first year of treatment To demonstrate that brolucizumab is non-inferior to aflibercept with respect after the first year of treatment
- Secondary Outcome Measures
Name Time Method 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) End of the trial
Trial Locations
- Locations (5)
Aravind Eye Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Aravind Eye Hospital Retina Vitreous services
🇮🇳Madurai, TAMIL NADU, India
Dr .Rajendraprasad Centre for ophthalmic sciences
🇮🇳Delhi, DELHI, India
Post Graduate Insitute of Medical Edication and Research
🇮🇳Chandigarh, CHANDIGARH, India
Sankara Nethralaya
🇮🇳Chennai, TAMIL NADU, India
Aravind Eye Hospital🇮🇳Coimbatore, TAMIL NADU, IndiaDr Saravanan VeerapanPrincipal investigator9790697555saravananvr@gmail.com