Prospective Study to Determine the Effect of Subconjunctival Bevacizumab (AVASTIN) in Corneal Neovascularization

NCT00555594 | Completed Phase 2 DMC

• 1 other identifier: Cornea2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of subconjunctival Bevacizumab in corneal neovascularization

Conditions

Corneal Neovascularization

Keywords

corneal neovascularization; Bevacizumab (Avastin); Immunologic rejection; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Anterior segment slit-lamp photographs and fluorescein angiograms Compared for any sign of diminished vascularization

  three weeks after treatment

Study Arms (2)

A

ACTIVE COMPARATOR

Patients with corneal neovascularization of infectious etiology, steroid reactors, and know glaucoma or glaucoma suspects. They received one dose of 0.1cc of subconjunctival Bevacizumab (Avastin™ Genentech, Inc, USA) in bulbar conjunctiva, 2 mm from the limbus, according to the location of the vessels.

Drug: Bevacizumab (Avastin)

B

ACTIVE COMPARATOR

Patients with corneal neovascularization of any cause except for infectious disease. Patients of this group received one application of 0.1cc of subconjunctival Bevacizumab™ + 0.1cc of triamcinolone acetonide (ATLC; Grin laboratories, México city) in bulbar conjunctiva, 2 mm from de limbus, according to the location of the vessels.

Drug: Bevacizumab (Avastin)

Interventions

Bevacizumab (Avastin) DRUG

One dose of 0.1cc of subconjunctival Bevacizumab was applied

A; B

Eligibility Criteria

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

You may qualify if:

• Presence of vessels in minimum one quadrant
• vessels that penetrate more than 0.5 mm of the limb, in any depth
• who had signed the informed consent
• those that could attend to frequent ophthalmologic revisions after treatment and could wait for 6 months before the surgical procedure.

You may not qualify if:

• Patients with urgent need of a penetrating keratoplasty, pregnancy or lactancy
• Patient that may need an additional procedure to penetrating keratoplasty.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead
• National Council of Science and Technology, Mexico: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"

Mexico City, 04030, Mexico

Location

Related Publications (10)

• Foulks GN, Sanfilippo FP, Locascio JA 3rd, MacQueen JM, Dawson DV. Histocompatibility testing for keratoplasty in high-risk patients. Ophthalmology. 1983 Mar;90(3):239-44. doi: 10.1016/s0161-6420(83)34575-9.

  PMID: 6346199 BACKGROUND

• Cursiefen C, Seitz B, Dana MR, Streilein JW. [Angiogenesis and lymphangiogenesis in the cornea. Pathogenesis, clinical implications and treatment options]. Ophthalmologe. 2003 Apr;100(4):292-9. doi: 10.1007/s00347-003-0798-y. German.

  PMID: 12682761 BACKGROUND

• Ciardella AP, Donsoff IM, Guyer DR, Adamis A, Yannuzzi LA. Antiangiogenesis agents. Ophthalmol Clin North Am. 2002 Dec;15(4):453-8. doi: 10.1016/s0896-1549(02)00042-1.

  PMID: 12515077 BACKGROUND

• Foulks GN, Sanfilippo F. Beneficial effects of histocompatibility in high-risk corneal transplantation. Am J Ophthalmol. 1982 Nov;94(5):622-9. doi: 10.1016/0002-9394(82)90007-1.

  PMID: 6756156 BACKGROUND

• Norrby K. In vivo models of angiogenesis. J Cell Mol Med. 2006 Jul-Sep;10(3):588-612. doi: 10.1111/j.1582-4934.2006.tb00423.x.

  PMID: 16989723 BACKGROUND

• Kuwano M, Fukushi J, Okamoto M, Nishie A, Goto H, Ishibashi T, Ono M. Angiogenesis factors. Intern Med. 2001 Jul;40(7):565-72. doi: 10.2169/internalmedicine.40.565.

  PMID: 11506294 BACKGROUND

• Kvanta A, Sarman S, Fagerholm P, Seregard S, Steen B. Expression of matrix metalloproteinase-2 (MMP-2) and vascular endothelial growth factor (VEGF) in inflammation-associated corneal neovascularization. Exp Eye Res. 2000 Apr;70(4):419-28. doi: 10.1006/exer.1999.0790.

  PMID: 10865990 BACKGROUND

• Gan L, Fagerholm P, Palmblad J. Vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in the regulation of corneal neovascularization and wound healing. Acta Ophthalmol Scand. 2004 Oct;82(5):557-63. doi: 10.1111/j.1600-0420.2004.00312.x.

  PMID: 15453853 BACKGROUND

• Manzano RP, Peyman GA, Khan P, Carvounis PE, Kivilcim M, Ren M, Lake JC, Chevez-Barrios P. Inhibition of experimental corneal neovascularisation by bevacizumab (Avastin). Br J Ophthalmol. 2007 Jun;91(6):804-7. doi: 10.1136/bjo.2006.107912. Epub 2006 Dec 19.

  PMID: 17179168 BACKGROUND

• Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9.

  PMID: 9377574 BACKGROUND

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; 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

• Hernández-Quintela Everardo, MD

  Consejo Nacional de Ciencia y Tecnología (CONACYT) grant no. 115755 (EHQ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: September 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2007
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

ME (1)