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

July 30, 2024 updated by: Asociación para Evitar la Ceguera en México
To determine the effect of subconjunctival Bevacizumab in corneal neovascularization

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 04030
        • Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimated)

November 8, 2007

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cornea2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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