Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study ID
NCT03042871
Phase
PHASE4
Status
Completed

Conditions

  • Choroidal Neovascularization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

First listed
Feb 3, 2017
Start date
Apr 30, 2015
Status verified
Mar 2019
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group A
    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.
  • Active Comparator: Group B
    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.

Primary Outcome Measure

Injection Number [ Time Frame: 12 months ]

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