Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization (SMILE)

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Choroidal Neovascularization

Treatments: Drug: 0.5mg intravitreal ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03042871

2015002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: 0.5mg intravitreal ranibizumab

Group B

Active Comparator group

Description:

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.

Treatment:

Drug: 0.5mg intravitreal ranibizumab