Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Zhongshan Ophthalmic Center, Sun Yat-sen University54 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Choroidal Neovascularization

Interventions

0.5mg intravitreal ranibizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

ZhongShan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Injection Number

Total IRV injection number

Time frame: 12 months

Best corrected visual acuity (BCVA)

Time frame: Change from baseline to 12 months

Secondary Outcomes

Retinal sensitivities on microperimetry

Time frame: Baseline and monthly after enrollment from baseline up to 12 months

Electrical response densities in the foveal on multifocal electroretinogram

Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.

Alterations of optic coherence tomography angiography

Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.

Retinal thickness on optic coherence tomography

Time frame: Baseline and monthly after enrollment up to 12 months.

Leakage in lesion on fluorescein fundus angiography

Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.

Fixation stability on microperimetry

Time frame: Baseline and monthly after enrollment from baseline up to 12 months

Data from ClinicalTrials.gov

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