drugset / Trial / NCT02342392
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-09
- Completion
- 2014-09
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Razeghinejad MR, Banifatemi M. Subconjunctival bevacizumab for primary pterygium excision; a randomized clinical trial. J Ophthalmic Vis Res. 2014 Jan;9(1):22-30.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results Besharati MR, Manaviat MR, Souzani A. Subconjunctival bevacizumab injection in treatment of pterygium. Acta Med Iran. 2011;49(3):179-83.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ranibizumab | Monoclonal antibody | 0.3 mg | Other |