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

This study has been completed.
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Universidad Nacional Autonoma de Mexico
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00555594
First received: November 7, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

To determine the effect of subconjunctival Bevacizumab in corneal neovascularization


Condition Intervention Phase
Corneal Neovascularization
Drug: Bevacizumab (Avastin)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Study to Determine the Effect of Subconjunctival Bevacizumab (AVASTIN) in Corneal Neovascularization

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • Anterior segment slit-lamp photographs and fluorescein angiograms Compared for any sign of diminished vascularization [ Time Frame: three weeks after treatment ]

Enrollment: 18
Study Start Date: September 2006
Study Completion Date: October 2007
Arms Assigned Interventions
Active Comparator: 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.
Drug: Bevacizumab (Avastin)
One dose of 0.1cc of subconjunctival Bevacizumab was applied
Active Comparator: 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.
Drug: Bevacizumab (Avastin)
One dose of 0.1cc of subconjunctival Bevacizumab was applied

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555594

Locations
Mexico
Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
Mexico City, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
National Council of Science and Technology, Mexico
Universidad Nacional Autonoma de Mexico
Investigators
Principal Investigator: Hernández-Quintela Everardo, MD Consejo Nacional de Ciencia y Tecnología (CONACYT) grant no. 115755 (EHQ)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00555594     History of Changes
Other Study ID Numbers: Cornea2
Study First Received: November 7, 2007
Last Updated: November 7, 2007
Health Authority: Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:
corneal neovascularization
Bevacizumab (Avastin)
Immunologic rejection
vascular endothelial growth factor

Additional relevant MeSH terms:
Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014