Exudative Age-related Macular Degeneration
Conditions
Keywords
neovascular age-related macular degeneration, Bevacizumab, Multicenter Randomized Study
Brief summary
Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.
Interventions
DRUGBevacizumab
Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week
DRUGBevacizumab 1
Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of neovascular Age-related macular degeneration * Signed informed consent
Exclusion criteria
* No other ocular fundus diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EDTRS visual acuity score | 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week | EDTRS visual acuity score is assessed at each timepoint for every group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| macular thickness in OCT | 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week | macular thickness is assessed at each timepoint for every group |
Countries
China
Outcome results
None listed