Phase 1
N=24
Topical Avastin for Treatment of Corneal Neovascularization
Corneal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT00559936 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. — 27.9 percent change since baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Topical Avastin 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. |
27.9 | — |
| PRIMARY Ocular and Systemic Safety |
— | — |
Summary
The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00559936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.