Topical Avastin for Treatment of Corneal Neovascularization

Corneal Neovascularization Clinical Trial

Official title:

Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559936
• Other study ID #: 06-12-077
• Secondary ID: 06-12-077
• Status: Completed
• Phase: Phase 1
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: April 2022
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.

Description:

Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female, at least 18 years of age

• Clinical stable corneal neovascularization (as defined above)

• Ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.

• All female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.

Exclusion Criteria:

• Current or recent (= 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye

• Current or recent (= 3 months) intravitreal drug injection to the study eye; recent (= 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents

• Uncontrolled hypertension defined as systolic blood pressure of = 150 mmHg or diastolic blood pressure of = 90 mmHg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident

• Patients age 75 or older; history of renal abnormalities

• Recent (= 3 months ) or planned surgery

• History of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or similar anticoagulant agent)

• All female patients of childbearing potential (a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries)

• Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Topical Avastin 1%
Avastin (bevacizumab) 1%

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.	The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.	Six Months
Primary	Ocular and Systemic Safety	The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.	All study visits