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SMILE: Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT03042871
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
39
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.5mg intravitreal ranibizumab
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: 0.5mg intravitreal ranibizumab
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

    		•
    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.

    Drug: 0.5mg intravitreal ranibizumab
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Injection Number [12 months]

      Total IRV injection number

    2. Best corrected visual acuity (BCVA) [Change from baseline to 12 months]

    Secondary Outcome Measures

    1. Retinal sensitivities on microperimetry [Baseline and monthly after enrollment from baseline up to 12 months]

    2. Electrical response densities in the foveal on multifocal electroretinogram [Baseline, 3 months, 6 months and 12 months after enrollment.]

    3. Alterations of optic coherence tomography angiography [Baseline, 3 months, 6 months and 12 months after enrollment.]

    4. Retinal thickness on optic coherence tomography [Baseline and monthly after enrollment up to 12 months.]

    5. Leakage in lesion on fluorescein fundus angiography [Baseline, 3 months, 6 months and 12 months after enrollment.]

    6. Fixation stability on microperimetry [Baseline and monthly after enrollment from baseline up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ZhongShan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    • Study Chair: Xiaoyan Ding, PhD, ZZhongShan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Xiaoyan Ding, Professor,PhD,MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT03042871
    Other Study ID Numbers:
    • 2015002
    First Posted:
    Feb 3, 2017
    Last Update Posted:
    Mar 11, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Xiaoyan Ding, Professor,PhD,MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
    PM-CNV ,Ranibizumab, Dosing Strategy
    Additional relevant MeSH terms:
    Choroidal Neovascularization
    Neovascularization, Pathologic
    Ranibizumab

    Study Results

    No Results Posted as of Mar 11, 2019