NCT03042871

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

August 21, 2016

Last Update Submit

March 7, 2019

Conditions

Choroidal Neovascularization

Keywords

PM-CNV ,Ranibizumab, Dosing Strategy

Outcome Measures

Primary Outcomes (2)

  • Injection Number

    Total IRV injection number

    12 months

  • Best corrected visual acuity (BCVA)

    Change from baseline to 12 months

Secondary Outcomes (6)

  • Retinal sensitivities on microperimetry

    Baseline and monthly after enrollment from baseline up to 12 months

  • Electrical response densities in the foveal on multifocal electroretinogram

    Baseline, 3 months, 6 months and 12 months after enrollment.

  • Alterations of optic coherence tomography angiography

    Baseline, 3 months, 6 months and 12 months after enrollment.

  • Retinal thickness on optic coherence tomography

    Baseline and monthly after enrollment up to 12 months.

  • Leakage in lesion on fluorescein fundus angiography

    Baseline, 3 months, 6 months and 12 months after enrollment.

  • +1 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

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

Also known as: IVR 0.5mg
Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZhongShan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (14)

  • Van Newkirk MR. The Hong Kong vision study: a pilot assessment of visual impairment in adults. Trans Am Ophthalmol Soc. 1997;95:715-49.

    PMID: 9440191BACKGROUND

  • Yoshida T, Ohno-Matsui K, Yasuzumi K, Kojima A, Shimada N, Futagami S, Tokoro T, Mochizuki M. Myopic choroidal neovascularization: a 10-year follow-up. Ophthalmology. 2003 Jul;110(7):1297-305. doi: 10.1016/S0161-6420(03)00461-5.

    PMID: 12867382BACKGROUND

  • Wong TY, Foster PJ, Hee J, Ng TP, Tielsch JM, Chew SJ, Johnson GJ, Seah SK. Prevalence and risk factors for refractive errors in adult Chinese in Singapore. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2486-94.

    PMID: 10937558BACKGROUND

  • Chan WM, Ohji M, Lai TY, Liu DT, Tano Y, Lam DS. Choroidal neovascularisation in pathological myopia: an update in management. Br J Ophthalmol. 2005 Nov;89(11):1522-8. doi: 10.1136/bjo.2005.074716.

    PMID: 16234465BACKGROUND

  • Jones D, Luensmann D. The prevalence and impact of high myopia. Eye Contact Lens. 2012 May;38(3):188-96. doi: 10.1097/ICL.0b013e31824ccbc3.

    PMID: 22495679BACKGROUND

  • Miller DG, Singerman LJ. Vision loss in younger patients: a review of choroidal neovascularization. Optom Vis Sci. 2006 May;83(5):316-25. doi: 10.1097/01.opx.0000216019.88256.eb.

    PMID: 16699445BACKGROUND

  • Sun J, Zhou J, Zhao P, Lian J, Zhu H, Zhou Y, Sun Y, Wang Y, Zhao L, Wei Y, Wang L, Cun B, Ge S, Fan X. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7504-9. doi: 10.1167/iovs.11-8343.

    PMID: 23060137BACKGROUND

  • Nagaoka N, Shimada N, Hayashi W, Hayashi K, Moriyama M, Yoshida T, Tokoro T, Ohno-Matsui K. Characteristics of periconus choroidal neovascularization in pathologic myopia. Am J Ophthalmol. 2011 Sep;152(3):420-427.e1. doi: 10.1016/j.ajo.2011.03.002. Epub 2011 Jun 22.

    PMID: 21696698BACKGROUND

  • Verteporfin in Photodynamic Therapy Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin. 1-year results of a randomized clinical trial--VIP report no. 1. Ophthalmology. 2001 May;108(5):841-52. doi: 10.1016/s0161-6420(01)00544-9.

    PMID: 11320011BACKGROUND

  • Blinder KJ, Blumenkranz MS, Bressler NM, Bressler SB, Donato G, Lewis H, Lim JI, Menchini U, Miller JW, Mones JM, Potter MJ, Pournaras C, Reaves A, Rosenfeld P, Schachat AP, Schmidt-Erfurth U, Sickenberg M, Singerman LJ, Slakter JS, Strong HA, Virgili G, Williams GA. Verteporfin therapy of subfoveal choroidal neovascularization in pathologic myopia: 2-year results of a randomized clinical trial--VIP report no. 3. Ophthalmology. 2003 Apr;110(4):667-73. doi: 10.1016/s0161-6420(02)01998-x.

    PMID: 12689884BACKGROUND

  • Nguyen QD, Shah S, Tatlipinar S, Do DV, Anden EV, Campochiaro PA. Bevacizumab suppresses choroidal neovascularisation caused by pathological myopia. Br J Ophthalmol. 2005 Oct;89(10):1368-70. No abstract available.

    PMID: 16170134BACKGROUND

  • Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

    PMID: 24326106BACKGROUND

  • Grunwald JE, Daniel E, Huang J, Ying GS, Maguire MG, Toth CA, Jaffe GJ, Fine SL, Blodi B, Klein ML, Martin AA, Hagstrom SA, Martin DF; CATT Research Group. Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2014 Jan;121(1):150-161. doi: 10.1016/j.ophtha.2013.08.015. Epub 2013 Sep 29.

    PMID: 24084496BACKGROUND

  • Kung YH, Wu TT, Huang YH. One-year outcome of two different initial dosing regimens of intravitreal ranibizumab for myopic choroidal neovascularization. Acta Ophthalmol. 2014 Dec;92(8):e615-20. doi: 10.1111/aos.12457. Epub 2014 Jun 12.

    PMID: 24924911BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaoyan Ding, PhD

    ZZhongShan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,PhD,MD

Study Record Dates

First Submitted

August 21, 2016

First Posted

February 3, 2017

Study Start

April 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

CN(1)