Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study
Overview
- Phase
- Phase 4
- Intervention
- 0.5mg intravitreal ranibizumab
- Conditions
- Choroidal Neovascularization
- Sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Injection Number
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to compare the efficacy (times of injection, change of visual acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological myopia choroidal neovascularization (PM-CNV).
Detailed Description
PM is a common disease in east asia, while PM-CNV affect 5%-10% PM patients.PM-CNV has specific characteristics, including small dimensions and limited exudative manifestations comparing with age-related macular degeneration. However, treatment regimen and re-treatment criteria follow the PrONTO protocol. The question of the optimal dose and treatment regimen in myopic CNV management is still unresolved. There is no unequivocal evidence suggesting hat PRN treatment is more effective than a loading phase followed by an as-needed variable dosage regimen.
Investigators
Xiaoyan Ding
Professor,PhD,MD
Zhongshan Ophthalmic Center, Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •older then 18 years old
- •refractive error ≥ -6.0 diopters or axial length ≥ 26.0mm
- •active CNV due to high myopic which is the only reason cause visual loss confirmed by fluorescein fundus angiography
- •BCVA ≥ 24.0 and ≤73 letters at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study visual acuity chart.
Exclusion Criteria
- •history of (a) stroke,(b) laser photocoagulation involved macular area in study eye, (c) intraocular treatment with corticosteroids or intraocular surgery or anti vascular endothelial growth factor or verteporfin photodynamic therapy within 6 months in study eye, or (d) hypersensitivity to ranibizumab or fluorescein
- •presence of active infectious disease or confirmed intraocular pressure ≥ 21.0 mmHg
- •pregnant or nursing women
- •uncontrolled high blood pressure ≥ 150/90 mmHg or uncontrolled fasting blood glucose ≥ 7 mmol/L
Arms & Interventions
Group A
Group A included 30 patients treated with one 0.5mg intravitreal ranibizumab injection. All patients were followed monthly for 12 months with additional injections performed as needed.
Intervention: 0.5mg intravitreal ranibizumab
Group B
Group B included 30 patients treated with three monthly 0.5mg intravitreal ranibizumab injections. All patients were followed monthly for 12 months with additional injections performed as needed.
Intervention: 0.5mg intravitreal ranibizumab
Outcomes
Primary Outcomes
Injection Number
Time Frame: 12 months
Total IRV injection number
Best corrected visual acuity (BCVA)
Time Frame: Change from baseline to 12 months
Secondary Outcomes
- Retinal sensitivities on microperimetry(Baseline and monthly after enrollment from baseline up to 12 months)
- Electrical response densities in the foveal on multifocal electroretinogram(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Alterations of optic coherence tomography angiography(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Retinal thickness on optic coherence tomography(Baseline and monthly after enrollment up to 12 months.)
- Leakage in lesion on fluorescein fundus angiography(Baseline, 3 months, 6 months and 12 months after enrollment.)
- Fixation stability on microperimetry(Baseline and monthly after enrollment from baseline up to 12 months)