A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema DME10047060
- Registration Number
- NL-OMON50742
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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:
*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 *m 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.
- 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, interfere with study
results
- Any active intraocular or periocular infection or active intraocular
inflammation 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.
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate that brolucizumab is noninferior to aflibercept with respect to<br /><br>the visual outcome after the first year of treatment. Measured as change from<br /><br>baseline in BCVA at Week 52.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To demonstrate that brolucizumab is noninferior to aflibercept with respect<br /><br>to visual outcome during the last 3 months of the first year of treatment<br /><br>- To estimate the proportion of patients treated at q12w frequency with<br /><br>brolucizumab<br /><br>- To estimate the predictive value of the first q12w cycle for maintenance of<br /><br>q12w treatment with brolucizumab<br /><br>- To evaluate the functional and anatomical outcome with brolucizumab relative<br /><br>to aflibercept<br /><br>- To evaluate the effect of brolucizumab relative to aflibercept on the<br /><br>Diabetic Retinopathy status<br /><br>- To assess the safety and tolerability of brolucizumab relative to aflibercept<br /><br>- To evaluate the effect of brolucizumab relative to aflibercept on<br /><br>patient-reported outcomes (VFQ-25) </p><br>