Bevacizumab for the Treatment of Corneal Neovascularization

NCT00992849 | Unknown Phase 2 DMC

• 1 other identifier: 98-0918C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to assess the efficacy and safety of the inhibitory effect of bevacizumab (Avastin) with different routes including topical and subconjunctival application on corneal neovascularization in the human eyes.

Conditions

Corneal Neovascularization

Keywords

Corneal neovascularization; bevacizumab

Outcome Measures

Primary Outcomes (1)

• Regression of corneal neovascularization

  6 months

Secondary Outcomes (1)

• visual acuity, lipid keratopathy, side effect

  6 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Arm type to experimental based on single group assignment. Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized monoclonal antibody that recognises and blocks vascular endothelial growth factor (VEGF).VEGF is a chemical signal that stimulates the growth of new blood vessels.

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Topical 10 mg/cc or subconjunctival 2.5 mg/0.1cc

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm.
• The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), ocular surface reconstruction , trauma, infectious or non-infectious corneal ulcer.
• Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25.
• Post-PSP or ocular surface reconstruction corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
• The corneal neovascularization was refractory to other medical treatment.
• The patient had received PKP or other corneal surgeries mort than half a year ago and was not in the acute post-operation phase.
• The patient had no active endophthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases.
• The patient signed inform consent to have regular follow up and treatment.

You may not qualify if:

• The neovascularization had clinical improvement three months before the first injection.
• The lipid keratopathy had clinical improvement three months before the first injection.
• The patient that suspected to have poor visual outcome or had already been light sense negative Glaucoma patient that had uncontrolled intraocular pressure.
• Poor corneal epithelialization.
• Patient that had systemic disease which was not suitable for bevacizumab use.
• Pregnant patient.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

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

• Ching-Hsi Hsiao, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2012
• Last Updated: October 15, 2009

Record last verified: 2009-10

Locations

TW (1)