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Completed

NCT Number: NCT03042871

Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ZhongShan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5mg intravitreal ranibizumab

Drug

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

Other names: IVR 0.5mg

Primary outcomes

  1. Injection Number

    Time frame: 12 months

    Total IRV injection number

  2. Best corrected visual acuity (BCVA)

    Time frame: Change from baseline to 12 months

Secondary outcomes

  1. Retinal sensitivities on microperimetry

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

  2. Electrical response densities in the foveal on multifocal electroretinogram

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

  3. Alterations of optic coherence tomography angiography

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

  4. Retinal thickness on optic coherence tomography

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

  5. Leakage in lesion on fluorescein fundus angiography

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

  6. Fixation stability on microperimetry

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

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: SMILE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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