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

NCT ID: NCT00555594

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-10-31

Brief Summary

To determine the effect of subconjunctival Bevacizumab in corneal neovascularization

Detailed Description

Corneal transplantation is the most commonly performed transplant surgery in the world today. Immunologic rejection is the leading cause of graft failure, with about 25% of graft recipients experiencing at least one episode of rejection. Of these episodes, about 20% are irreversible. The rate of corneal graft rejection in high-risk eyes, such as corneal neovascularization, has been reported to be 50% to 70%. Vascularized corneas have a much higher rate of graft rejection than avascular corneas. Whereas the normal cornea is devoid of blood and lymphatic vessels, both can invade the cornea secondary to a variety of corneal diseases and after surgery. This not only reduces visual acuity, but also renders such a cornea high-risk, if subsequent corneal transplantation is performed.Anti-angiogenesis, the pharmacologic inhibition of new blood vessel growth and formation, is a new treatment strategy under active and vigorous investigation. Multiple growth factors have been shown to contribute to the molecular events involved in the regulation of blood vessel growth Similarly, it is assumed that angiogenic growth factors such as vascular endothelial growth factor (VEGF), considered a major pro-angiogenic factor, could play a role in the pathogenesis of neovascularization.

Several approaches can be taken to neutralize VEGF. Bevacizumab (Avastin) is a full-length humanized murine monoclonal antibody against the VEGF molecule.It binds to and inhibits the biologic activity of human VEGF preventing the interaction of this molecule to its receptors on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new vessel formation.

There is evidence that triamcinolone acetonide (TA) inhibits vasogenic edema and inflammation, decreases vascular leakage, reduces the secretion of VEGF by pigment epithelial cells during oxidative stress and, down-regulates the expression of the VEGF gene in vascular smooth muscle cells Furthermore, TA decreases the paracellular permeability of cultured epithelial cells and down-regulates the inflammatory expression of endothelial adhesion molecules.

Conditions

Corneal Neovascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

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.

Group Type: ACTIVE_COMPARATOR

Bevacizumab (Avastin)

Intervention Type: DRUG

One dose of 0.1cc of subconjunctival Bevacizumab was applied

B

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.

Group Type: ACTIVE_COMPARATOR

Bevacizumab (Avastin)

Intervention Type: DRUG

One dose of 0.1cc of subconjunctival Bevacizumab was applied

Interventions

Bevacizumab (Avastin)

One dose of 0.1cc of subconjunctival Bevacizumab was applied

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Presence of vessels in minimum one quadrant

2. vessels that penetrate more than 0.5 mm of the limb, in any depth

3. who had signed the informed consent

4. those that could attend to frequent ophthalmologic revisions after treatment and could wait for 6 months before the surgical procedure.

Exclusion Criteria

1. Patients with urgent need of a penetrating keratoplasty, pregnancy or lactancy

2. Patient that may need an additional procedure to penetrating keratoplasty.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role: lead

Principal Investigators

Hernández-Quintela Everardo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mexico City, , Mexico

Countries

Mexico

References

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Other Identifiers

Cornea2

Identifier Type: -

Identifier Source: org_study_id