Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study

Conditions
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Choroidal Neovascularization

Intervention / Treatment
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* Drug: 0.5mg intravitreal ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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. | Drug: 0.5mg intravitreal ranibizumab<br>* Patients received ranibizumab (0.5mg, Novartis AG, Basel, Switzerland) via a pars plana transcleral injection through 30-gauge needle at 3.5 to 4mm of inferotemporal limbus. Levofloxacin eye drops ( Cravit Eye Drops, Santen, Japan) was instilled 4 times a day in the study eye before the treatment at least 1 day. Povidone-iodine (5%, Luofushan Pharmaceutical Co., China) was applied to the conjunctiva bulbi and the fornices for at least 3 minutes before injection. Patients were instructed to continue the levofloxacin eye drops 4 times a day for 3 days<br>* Other names: IVR 0.5mg;|
| Active Comparator: Group B<br>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. | Drug: 0.5mg intravitreal ranibizumab<br>* Patients received ranibizumab (0.5mg, Novartis AG, Basel, Switzerland) via a pars plana transcleral injection through 30-gauge needle at 3.5 to 4mm of inferotemporal limbus. Levofloxacin eye drops ( Cravit Eye Drops, Santen, Japan) was instilled 4 times a day in the study eye before the treatment at least 1 day. Povidone-iodine (5%, Luofushan Pharmaceutical Co., China) was applied to the conjunctiva bulbi and the fornices for at least 3 minutes before injection. Patients were instructed to continue the levofloxacin eye drops 4 times a day for 3 days<br>* Other names: IVR 0.5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Number | Total IRV injection number | 12 months | 
| Best corrected visual acuity (BCVA) |  | Change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PM-CNV ,Ranibizumab, Dosing Strategy