Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
NCT ID: NCT02342392
Last Updated: 2015-01-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-09-30
Study Completion Date
2014-09-30
Brief Summary
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The purpose of this study is to evaluate the pterygium vascularity and size before and after intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium excision surgery.
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Detailed Description
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The purpose of this study is to:
1. Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
2. Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
3. Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.
1. Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
2. Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
3. Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.
Conditions
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Pterygium
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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treatment group
intralesional ranibizumab injected
Group Type
ACTIVE_COMPARATOR
ranibizumab
Intervention Type
DRUG
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.
control group
no intralesional ranibizumab injected.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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ranibizumab
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.
Intervention Type
DRUG
Other Intervention Names
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Lucentis
Eligibility Criteria
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Inclusion Criteria
* All patients with primary pterygium.
* Grade T3 (fleshy) pterygium.
* Grade T3 (fleshy) pterygium.
Exclusion Criteria
* Patients with other ocular surface disorders.
* Previous ocular surgery or trauma.
* History of systemic thromboembolic event.
* Pregnant women and lactating mother.
* Previous ocular surgery or trauma.
* History of systemic thromboembolic event.
* Pregnant women and lactating mother.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Universiti Sains Malaysia
OTHER
Sponsor Role
lead
Responsible Party
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Hao Chi Ho
DR.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hao Chi Ho, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universiti Sains Malaysia
References
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Shenasi A, Mousavi F, Shoa-Ahari S, Rahimi-Ardabili B, Fouladi RF. Subconjunctival bevacizumab immediately after excision of primary pterygium: the first clinical trial. Cornea. 2011 Nov;30(11):1219-22. doi: 10.1097/ICO.0b013e31820ca63f.
Reference Type
RESULT
Shahin MM, Elbendary AM, Elwan MM. Intraoperative subconjunctival bevacizumab as an adjunctive treatment in primary pterygium: a preliminary report. Ophthalmic Surg Lasers Imaging. 2012 Nov-Dec;43(6):459-66. doi: 10.3928/15428877-20120802-02. Epub 2012 Aug 10.
Reference Type
RESULT
Ozgurhan EB, Agca A, Kara N, Yuksel K, Demircan A, Demirok A. Topical application of bevacizumab as an adjunct to recurrent pterygium surgery. Cornea. 2013 Jun;32(6):835-8. doi: 10.1097/ICO.0b013e3182772d4e.
Reference Type
RESULT
Karalezli A, Kucukerdonmez C, Akova YA, Koktekir BE. Does topical bevacizumab prevent postoperative recurrence after pterygium surgery with conjunctival autografting? Int J Ophthalmol. 2014 Jun 18;7(3):512-6. doi: 10.3980/j.issn.2222-3959.2014.03.23. eCollection 2014.
Reference Type
RESULT
Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.
Reference Type
RESULT
Hu Q, Qiao Y, Nie X, Cheng X, Ma Y. Bevacizumab in the treatment of pterygium: a meta-analysis. Cornea. 2014 Feb;33(2):154-60. doi: 10.1097/ICO.0000000000000037.
Reference Type
RESULT
Bahar I, Kaiserman I, McAllum P, Rootman D, Slomovic A. Subconjunctival bevacizumab injection for corneal neovascularization in recurrent pterygium. Curr Eye Res. 2008 Jan;33(1):23-8. doi: 10.1080/02713680701799101.
Reference Type
RESULT
Bayar SA, Kucukerdonmez C, Oner O, Akova YA. Subconjunctival bevacizumab in the impending recurrent pterygia. Int Ophthalmol. 2014 Jun;34(3):541-7. doi: 10.1007/s10792-013-9852-1. Epub 2013 Sep 12.
Reference Type
RESULT
Fallah Tafti MR, Khosravifard K, Mohammadpour M, Hashemian MN, Kiarudi MY. Efficacy of intralesional bevacizumab injection in decreasing pterygium size. Cornea. 2011 Feb;30(2):127-9. doi: 10.1097/ICO.0b013e3181e16d67.
Reference Type
RESULT
Besharati MR, Manaviat MR, Souzani A. Subconjunctival bevacizumab injection in treatment of pterygium. Acta Med Iran. 2011;49(3):179-83.
Reference Type
RESULT
Sarac O, Demirel S, Oltulu R. Efficacy of intralesional bevacizumab administration in primary pterygium: a quantitative analysis. Eye Contact Lens. 2014 Jan;40(1):46-50. doi: 10.1097/ICL.0000000000000004.
Reference Type
RESULT
Kocabora SM, Fazil K, Ozsutcu M, Doyduk-Kocabora A, Gulkilik G. Subconjunctival bevacizumab injection in the surgery of primary pterygium: comparison with intraoperative mitomycin-C. Bull Soc Belge Ophtalmol. 2013;(322):7-12.
Reference Type
RESULT
Razeghinejad MR, Banifatemi M. Subconjunctival bevacizumab for primary pterygium excision; a randomized clinical trial. J Ophthalmic Vis Res. 2014 Jan;9(1):22-30.
Reference Type
RESULT
Razeghinejad R, Banifatemi M, Hosseini H. The effect of different doses of subconjunctival bevacizumab on the recurrence rate of excised primary pterygium. Bull Soc Belge Ophtalmol. 2013;(322):13-20.
Reference Type
RESULT
Lee DH, Cho HJ, Kim JT, Choi JS, Joo CK. Expression of vascular endothelial growth factor and inducible nitric oxide synthase in pterygia. Cornea. 2001 Oct;20(7):738-42. doi: 10.1097/00003226-200110000-00013.
Reference Type
BACKGROUND
Blaudschun R, Sunderkotter C, Brenneisen P, Hinrichs R, Peters T, Schneider L, Razi-Wolf Z, Hunzelmann N, Scharffetter-Kochanek K. Vascular endothelial growth factor causally contributes to the angiogenic response upon ultraviolet B irradiation in vivo. Br J Dermatol. 2002 Apr;146(4):581-7. doi: 10.1046/j.1365-2133.2002.04669.x.
Reference Type
BACKGROUND
Di Girolamo N, Chui J, Coroneo MT, Wakefield D. Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases. Prog Retin Eye Res. 2004 Mar;23(2):195-228. doi: 10.1016/j.preteyeres.2004.02.002.
Reference Type
BACKGROUND
Tan DT, Lim AS, Goh HS, Smith DR. Abnormal expression of the p53 tumor suppressor gene in the conjunctiva of patients with pterygium. Am J Ophthalmol. 1997 Mar;123(3):404-5. doi: 10.1016/s0002-9394(14)70141-2.
Reference Type
BACKGROUND
Tan DT, Chee SP, Dear KB, Lim AS. Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol. 1997 Oct;115(10):1235-40. doi: 10.1001/archopht.1997.01100160405001.
Reference Type
BACKGROUND
Prabhasawat P, Barton K, Burkett G, Tseng SC. Comparison of conjunctival autografts, amniotic membrane grafts, and primary closure for pterygium excision. Ophthalmology. 1997 Jun;104(6):974-85. doi: 10.1016/s0161-6420(97)30197-3.
Reference Type
BACKGROUND
Ang LP, Chua JL, Tan DT. Current concepts and techniques in pterygium treatment. Curr Opin Ophthalmol. 2007 Jul;18(4):308-13. doi: 10.1097/ICU.0b013e3281a7ecbb.
Reference Type
BACKGROUND
Prabhasawat P, Tesavibul N, Leelapatranura K, Phonjan T. Efficacy of subconjunctival 5-fluorouracil and triamcinolone injection in impending recurrent pterygium. Ophthalmology. 2006 Jul;113(7):1102-9. doi: 10.1016/j.ophtha.2006.02.026. Epub 2006 May 26.
Reference Type
BACKGROUND
Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.
Reference Type
BACKGROUND
Razeghinejad MR, Hosseini H, Ahmadi F, Rahat F, Eghbal H. Preliminary results of subconjunctival bevacizumab in primary pterygium excision. Ophthalmic Res. 2010;43(3):134-8. doi: 10.1159/000252980. Epub 2009 Oct 29.
Reference Type
BACKGROUND
Poenaru Sava MG, Raica ML, Cimpean AM. VEGF mRNA assessment in human pterygium: a new 'scope' for a future hope. Ophthalmic Res. 2014;52(3):130-5. doi: 10.1159/000363142. Epub 2014 Oct 3.
Reference Type
BACKGROUND
Mansour AM. Treatment of inflamed pterygia or residual pterygial bed. Br J Ophthalmol. 2009 Jul;93(7):864-5. doi: 10.1136/bjo.2008.155291.
Reference Type
BACKGROUND
Teng CC, Patel NN, Jacobson L. Effect of subconjunctival bevacizumab on primary pterygium. Cornea. 2009 May;28(4):468-70. doi: 10.1097/ICO.0b013e31818d382d.
Reference Type
BACKGROUND
Wu PC, Kuo HK, Tai MH, Shin SJ. Topical bevacizumab eyedrops for limbal-conjunctival neovascularization in impending recurrent pterygium. Cornea. 2009 Jan;28(1):103-4. doi: 10.1097/ICO.0b013e3181822615.
Reference Type
BACKGROUND
Hosseini H, Nejabat M, Khalili MR. Bevacizumab (Avastin) as a potential novel adjunct in the management of pterygia. Med Hypotheses. 2007;69(4):925-7. doi: 10.1016/j.mehy.2007.01.047. Epub 2007 Mar 26.
Reference Type
RESULT
Hurmeric V, Vaddavalli P, Galor A, Perez VL, Roman JS, Yoo SH. Single and multiple injections of subconjunctival ranibizumab for early, recurrent pterygium. Clin Ophthalmol. 2013;7:467-73. doi: 10.2147/OPTH.S40400. Epub 2013 Mar 4.
Reference Type
RESULT
Galor A, Yoo SH, Piccoli FV, Schmitt AJ, Chang V, Perez VL. Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery. Am J Ophthalmol. 2010 Jun;149(6):926-931.e2. doi: 10.1016/j.ajo.2010.01.015. Epub 2010 Apr 24.
Reference Type
RESULT
Mandalos A, Tsakpinis D, Karayannopoulou G, Tsinopoulos I, Karkavelas G, Chalvatzis N, Dimitrakos S. The effect of subconjunctival ranibizumab on primary pterygium: a pilot study. Cornea. 2010 Dec;29(12):1373-9. doi: 10.1097/ICO.0b013e3181d927b9.
Reference Type
RESULT
Benayoun Y, Adenis JP, Casse G, Forte R, Robert PY. Effects of subconjunctival bevacizumab on corneal neovascularization: results of a prospective study. Cornea. 2012 Aug;31(8):937-44. doi: 10.1097/ICO.0b013e31823f8d71.
Reference Type
RESULT
Enkvetchakul O, Thanathanee O, Rangsin R, Lekhanont K, Suwan-Apichon O. A randomized controlled trial of intralesional bevacizumab injection on primary pterygium: preliminary results. Cornea. 2011 Nov;30(11):1213-8. doi: 10.1097/ICO.0b013e31821c9b44.
Reference Type
RESULT
Lekhanont K, Patarakittam T, Thongphiew P, Suwan-apichon O, Hanutsaha P. Randomized controlled trial of subconjunctival bevacizumab injection in impending recurrent pterygium: a pilot study. Cornea. 2012 Feb;31(2):155-61. doi: 10.1097/ICO.0b013e3182151e0e.
Reference Type
RESULT
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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