NCT00681603

Brief Summary

  1. 1.Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
  2. 2.Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
  3. 3.Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
Last Updated

May 21, 2008

Status Verified

August 1, 2007

Enrollment Period

6 months

First QC Date

May 19, 2008

Last Update Submit

May 20, 2008

Conditions

Lipid KeratopathyPenetrating KeratoplastyHerpetic KeratopathyRosacea

Keywords

corneal neovascularizationlipid keratopathypenetrating keratopathybevacizumabAvastinsubconjunctival injection

Outcome Measures

Primary Outcomes (1)

  • Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity

    prospective

Secondary Outcomes (1)

  • major side effects

    prospective

Study Arms (1)

1

EXPERIMENTAL

13 cases that accepted subconjunctival injection of bevacizumab

Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)

Interventions

subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)DRUG

subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed.

Also known as: bevacizumab ( Avastin )
1

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), 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), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
  • Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
  • Post-PKP 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 more than half a year ago and was not in the acute post-operation phase
  • The patient had no active endopthalmitis, 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
  • Post-PKP patient that had graft failure or rejection
  • Patient that had systemic disease which was not suitable for bevacizumab use
  • Pregnant patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital,

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

RosaceaCorneal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesCorneal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Wei-Li Chen

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

August 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 21, 2008

Record last verified: 2007-08

Locations

TW(1)