CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 266 enrolled
Drug / intervention
Brolucizumab +1 moredrug
Likely dose
Brolucizumab 6 mg intravitreal injection: 5 injections every 6 weeks, then every 12 or 8 weeks; Aflibercept 2 mg intravitreal injection: 5 injections every 4 weeks, then every 8 weeksAI-extracted
Key inclusion· 5
  • ✓Type 1 or type 2 diabetes mellitus with HbA1c ≤10% at screening
  • ✓Age ≥18 years at screening
  • ✓Visual impairment due to DME with BCVA between 78 and 23 letters (Snellen equivalent 20/32 to 20/320)
  • ✓Central subfield retinal thickness ≥320 μm on SD-OCT with DME involving center of macula
Key exclusion· 8
  • ✕Active proliferative diabetic retinopathy in study eye
  • ✕Structural foveal damage including RPE atrophy, subretinal fibrosis, laser scars, or epiretinal membrane involving fovea likely to preclude visual improvement
  • ✕Uncontrolled glaucoma defined as IOP >25 mmHg on medication or per investigator judgment
  • ✕Active intraocular or periocular infection or intraocular inflammation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058067
NCT04058067Phase 3Completed
CompareCT.gov

A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

Novartis Pharmaceuticals·interventional·Posted Aug 15, 2019·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating Brolucizumab and Aflibercept for Diabetic Macular Edema. Completed, enrolled 266 participants across 24 sites.

Detailed Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartAug 23, 2019
Primary CompletionJan 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.9 years ago

Interventions

Brolucizumabdrug

5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance

Afliberceptdrug

5 x every 4 weeks loading then every 8 weeks maintenance