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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02342392
Other study ID # 1
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received January 14, 2015
Last updated January 14, 2015
Start date September 2012
Est. completion date September 2014

Study information

Verified date January 2015
Source University of Science Malaysia
Contact n/a
Is FDA regulated No
Health authority Malaysia: National Medical Research Register
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with primary 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ranibizumab
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Science Malaysia

References & Publications (35)

Ang LP, Chua JL, Tan DT. Current concepts and techniques in pterygium treatment. Curr Opin Ophthalmol. 2007 Jul;18(4):308-13. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Besharati MR, Manaviat MR, Souzani A. Subconjunctival bevacizumab injection in treatment of pterygium. Acta Med Iran. 2011;49(3):179-83. — View Citation

Blaudschun R, Sunderkötter 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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 201 — View Citation

Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. — View Citation

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. Epub 2007 Mar 26. — View Citation

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. — View Citation

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. — View Citation

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. eCol — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Nava-Castañeda 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 Experiment Oph — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 May 26. — View Citation

Razeghinejad MR, Banifatemi M. Subconjunctival bevacizumab for primary pterygium excision; a randomized clinical trial. J Ophthalmic Vis Res. 2014 Jan;9(1):22-30. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Au — View Citation

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. — View Citation

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. Erratum in: Arch Ophthalmol 1998 Apr;116(4):552. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary pterygium recurrence pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion) 1 year No
Secondary pterygium vessel area Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage. 1 week No
Secondary corneal pterygium area Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage. 1 week No
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