Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization
- Conditions
- Choroidal Neovascularization
- Interventions
- Registration Number
- NCT03042871
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A 0.5mg intravitreal ranibizumab 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. Group B 0.5mg intravitreal ranibizumab 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.
- Primary Outcome Measures
Name Time Method Injection Number 12 months Total IRV injection number
Best corrected visual acuity (BCVA) Change from baseline to 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
ZhongShan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China