Clinical trial NCT03042871: Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization
Official title: Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Choroidal Neovascularization
Keywords: PM-CNV ,Ranibizumab, Dosing Strategy
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Injection Number
timeFrame: 12 months
measure: Best corrected visual acuity (BCVA)
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Retinal sensitivities on microperimetry
timeFrame: Baseline and monthly after enrollment from baseline up to 12 months
measure: Electrical response densities in the foveal on multifocal electroretinogram
timeFrame: Baseline, 3 months, 6 months and 12 months after enrollment.
measure: Alterations of optic coherence tomography angiography
timeFrame: Baseline, 3 months, 6 months and 12 months after enrollment.
measure: Retinal thickness on optic coherence tomography
timeFrame: Baseline and monthly after enrollment up to 12 months.
measure: Leakage in lesion on fluorescein fundus angiography
timeFrame: Baseline, 3 months, 6 months and 12 months after enrollment.
measure: Fixation stability on microperimetry
timeFrame: Baseline and monthly after enrollment from baseline up to 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: ZhongShan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: ZZhongShan Ophthalmic Center, Sun Yat-sen University
name: Xiaoyan Ding, PhD
role: STUDY_CHAIR
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