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Topical Avastin for Treatment of Corneal Neovascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00559936
Recruitment Status : Completed
First Posted : November 16, 2007
Results First Posted : September 24, 2012
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

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

Condition or disease Intervention/treatment Phase
Corneal Neovascularization Drug: Topical Avastin 1% Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Study Start Date : February 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Topical Avastin 1.0%
Each patient will receive topical Avastin in one eye.
Drug: Topical Avastin 1%
Avastin (bevacizumab) 1%
Other Name: bevacizumab




Primary Outcome Measures :
  1. The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. [ Time Frame: Six Months ]
    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.

  2. Ocular and Systemic Safety [ Time Frame: All study visits ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559936


Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Reza Dana, M.D., MPH Massachusetts Eye and Ear Infirmary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00559936    
Other Study ID Numbers: 06-12-077
06-12-077 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
First Posted: November 16, 2007    Key Record Dates
Results First Posted: September 24, 2012
Last Update Posted: October 5, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Corneal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors