Topical Avastin for Treatment of Corneal Neovascularization

Mass Eye and Ear

Status and phase: Completed; Phase 1

Conditions: Corneal Neovascularization

Treatments: Drug: Topical Avastin 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT00559936

06-12-077 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Topical Avastin 1.0%

Experimental group

Description:

Each patient will receive topical Avastin in one eye.

Treatment:

Drug: Topical Avastin 1%