Clinical Trial: Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Zhongshan Ophthalmic Center, Sun Yet-san University

Current Primary Outcome: Best-corrected visual acuity [ Time Frame: Baseline and monthly after enrollment from baseline up to 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Retinal sensitivities on micrpperimetry [ 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 stablity on micrpperimetry [ Time Frame: Baseline and monthly after enrollment from baseline up to 12 months ]


Information By: Zhongshan Ophthalmic Center, Sun Yet-san University

Dates:
Date Received: August 21, 2016
Date Started: April 2015
Date Completion: April 2020
Last Updated: February 5, 2017
Last Verified: February 2017