Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study

NCT02342392 | Completed Phase 2

• 1 other identifier: 1
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pterygium

Keywords

pterygium; ranibizumab; anti-VEGF; recurrence; vascularity; size

Outcome Measures

Primary Outcomes (1)

• pterygium recurrence

  pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)

  1 year

Secondary Outcomes (2)

• pterygium vessel area

  1 week

• corneal pterygium area

  1 week

Study Arms (2)

treatment group

ACTIVE COMPARATOR

intralesional ranibizumab injected

Drug: ranibizumab

control group

NO INTERVENTION

no intralesional ranibizumab injected.

Interventions

ranibizumab DRUG

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

Also known as: Lucentis

treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with primary pterygium.
• Grade T3 (fleshy) pterygium.

You may not qualify if:

• Patients with other ocular surface disorders.
• Previous ocular surgery or trauma.
• History of systemic thromboembolic event.
• Pregnant women and lactating mother.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Related Publications (35)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 19553512 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.

  PMID: 19411971 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.

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• 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.

  PMID: 17367957 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.

  PMID: 23486999 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.

  PMID: 20417925 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.

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• 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.

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MeSH Terms

Conditions

Pterygium; Recurrence

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hao Chi Ho, MD

  Hospital Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 19, 2015

Record last verified: 2015-01