NCT02328209UnknownNot Applicable
Evaluation of the Efficacy and Continuance Rate of Treatment in Simplified Treat And Extend Regimen Using Ranibizumab in Exudative Age Related Macular Degeneration
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mie University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- A change from baselines best corrected visual acuity at 24 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ability to provide written informed consent for this study
- •age>=50years old
- •intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical age-related macular degeneration and PCV)
- •best corrected visual acuity>=0.05 -
Exclusion Criteria
- •past intravitreal anti-vascular endothelial growth factor therapy in the study eye
- •past intravitreal or subtenon injection of steroid therapy in the study eye
- •past vitrectomy therapy in the study eye
- •infection or suspicion of infection in eyes or periocular region
- •severe intraocular inflammation in eyes
- •past allergic reaction for ranibizumab
- •past allergic reaction for fluorescein, indocyanine green or iodine
- •pregnancy (positive pregnancy test) or lactating women
- •other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.
Arms & Interventions
ranibizumab
Experimental
ranibizumab
Intervention: ranibizumab (Drug)
Outcomes
Primary Outcomes
A change from baselines best corrected visual acuity at 24 months
Time Frame: 24 months
Secondary Outcomes
- 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)
- A drop-out rate of the 3 and 12 months(3 and 12 months)
- A treatment continuance rate until 24 months(24 months)
Investigators
Mineo Kondo
Mie University Graduate School of Medicine
Mie University
Study Sites (1)
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