Exudative Age-related Macular Degeneration
Conditions
Brief summary
Recently studies have shown that intravitreal injection of ranibizumab is effective for age related macular degeneration. However there are problems about injection regimen of maintenance phase. We plan to perform new simplified treat and extend regimen using ranibizumab.
Detailed description
The purpose of the present study is to evaluate the simplified treat and extend regimen using ranibizumab in eyes with wet age related macular degeneration about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.
Interventions
DRUGranibizumab
0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
Sponsors
Mie University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ability to provide written informed consent for this study 2. age\>=50years old 3. intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV) 4. best corrected visual acuity\>=0.05 -
Exclusion criteria
1. past intravitreal anti-vascular endothelial growth factor therapy in the study eye 2. past intravitreal or subtenon injection of steroid therapy in the study eye 3. past vitrectomy therapy in the study eye 4. infection or suspicion of infection in eyes or periocular region 5. severe intraocular inflammation in eyes 6. past allergic reaction for ranibizumab 7. past allergic reaction for fluorescein, indocyanine green or iodine 8. pregnancy (positive pregnancy test) or lactating women 9. other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change from baselines best corrected visual acuity at 24 months | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| A drop-out rate of the 3 and 12 months | 3 and 12 months |
| A treatment continuance rate until 24 months | 24 months |
| A change of best corrected visual acuity at 12 months | 12 months |
| A change from baselines central retinal thickness measured by spectral domain optical coherence tomography at 12 and 24 months | 12 and 24 months |
Countries
Japan
Outcome results
None listed