Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

Choroidal Neovascularization Clinical Trial

— SMILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042871
• Other study ID #: 2015002
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: July 2018

Study information

• Verified date: March 2019
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
China	ZhongShan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (14)

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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Miller DG, Singerman LJ. Vision loss in younger patients: a review of choroidal neovascularization. Optom Vis Sci. 2006 May;83(5):316-25. Review. — View 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. — View 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. Erratum in: Br J Ophthalmol. 2006 Jan;90(1):125. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection Number	Total IRV injection number	12 months
Primary	Best corrected visual acuity (BCVA)		Change from baseline to 12 months
Secondary	Retinal sensitivities on microperimetry		Baseline and monthly after enrollment from baseline up to 12 months
Secondary	Electrical response densities in the foveal on multifocal electroretinogram		Baseline, 3 months, 6 months and 12 months after enrollment.
Secondary	Alterations of optic coherence tomography angiography		Baseline, 3 months, 6 months and 12 months after enrollment.
Secondary	Retinal thickness on optic coherence tomography		Baseline and monthly after enrollment up to 12 months.
Secondary	Leakage in lesion on fluorescein fundus angiography		Baseline, 3 months, 6 months and 12 months after enrollment.
Secondary	Fixation stability on microperimetry		Baseline and monthly after enrollment from baseline up to 12 months

External Links

•   Website of Ophthalmic Research Institute/Laboratory, ZhongShan Ophthalmic Center, Sun Yat-sen University