Study Assessing the effect of Brolucizumab versus Aflibercept in Adult Patientswith Visual Damage related diabetes.
- Conditions
- Health Condition 1: H578- Other specified disorders of eye and adnexaHealth Condition 2: null- 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
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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
ïâ??· DME involving the center of the macula, with central subfield retinal
thickness (measured from RPE to ILM inclusively) of â�¥340 �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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>To demonstrate that brolucizumab is non-inferior to aflibercept with respect <br/ ><br>to the visual outcomeTimepoint: after the first year of treatment <br/ ><br> <br/ ><br>
- 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)Timepoint: End of the trial