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Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization (SMILE)

Primary Purpose

Choroidal Neovascularization

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

0.5mg intravitreal ranibizumab

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring PM-CNV ,Ranibizumab, Dosing Strategy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ZhongShan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Injection Number

Total IRV injection number

Best corrected visual acuity (BCVA)

Secondary Outcome Measures

Retinal sensitivities on microperimetry

Electrical response densities in the foveal on multifocal electroretinogram

Alterations of optic coherence tomography angiography

Retinal thickness on optic coherence tomography

Leakage in lesion on fluorescein fundus angiography

Fixation stability on microperimetry

Full Information

NCT ID

NCT03042871

First Posted

August 21, 2016

Last Updated

March 7, 2019

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03042871

Brief Title

Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Acronym

SMILE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization

Keywords

PM-CNV ,Ranibizumab, Dosing Strategy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

0.5mg intravitreal ranibizumab

Other Intervention Name(s)

IVR 0.5mg

Intervention Description

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

Primary Outcome Measure Information:

Title

Injection Number

Description

Total IRV injection number

Time Frame

12 months

Title

Best corrected visual acuity (BCVA)

Time Frame

Change from baseline to 12 months

Secondary Outcome Measure Information:

Title

Retinal sensitivities on microperimetry

Time Frame

Baseline and monthly after enrollment from baseline up to 12 months

Title

Electrical response densities in the foveal on multifocal electroretinogram

Time Frame

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

Title

Alterations of optic coherence tomography angiography

Time Frame

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

Title

Retinal thickness on optic coherence tomography

Time Frame

Baseline and monthly after enrollment up to 12 months.

Title

Leakage in lesion on fluorescein fundus angiography

Time Frame

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

Title

Fixation stability on microperimetry

Time Frame

Baseline and monthly after enrollment from baseline up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoyan Ding, PhD

Organizational Affiliation

ZZhongShan Ophthalmic Center, Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

ZhongShan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

9440191

Citation

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

Results Reference

background

PubMed Identifier

12867382

Citation

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.

Results Reference

background

PubMed Identifier

10937558

Citation

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.

Results Reference

background

PubMed Identifier

16234465

Citation

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.

Results Reference

background

PubMed Identifier

22495679

Citation

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.

Results Reference

background

PubMed Identifier

16699445

Citation

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.

Results Reference

background

PubMed Identifier

23060137

Citation

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.

Results Reference

background

PubMed Identifier

21696698

Citation

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.

Results Reference

background

PubMed Identifier

11320011

Citation

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.

Results Reference

background

PubMed Identifier

12689884

Citation

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.

Results Reference

background

PubMed Identifier

16170134

Citation

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. Erratum In: Br J Ophthalmol. 2006 Jan;90(1):125.

Results Reference

background

PubMed Identifier

24326106

Citation

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.

Results Reference

background

PubMed Identifier

24084496

Citation

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.

Results Reference

background

PubMed Identifier

24924911

Citation

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.

Results Reference

background

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Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

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