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Topical Avastin for Treatment of Corneal Neovascularization
This study is currently recruiting participants.
Verified by Massachusetts Eye and Ear Infirmary, January 2008
First Received: November 14, 2007   Last Updated: October 22, 2008   History of Changes
Sponsor: Massachusetts Eye and Ear Infirmary
Information provided by: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00559936
  Purpose

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


Condition Intervention Phase
Corneal Neovascularization
Drug: Topical Bevacizumab
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitoring the safety of the treatment: comprehensive eye examination, BCVA, IOP, evaluation of the lid/lashes, conjunctiva, cornea, anterior chamber, iris/pupil, lens, vitreous, macula and optic nerve, querying and recording of adverse events. [ Time Frame: Six Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
Each patient will receive topical Avastin in one eye.
Drug: Topical Bevacizumab
1.0% custom made topical Avastin twice a day for three weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559936

Contacts
Contact: Leila Smaga 617-573-4439 Leila_Smaga@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Leila Smaga     617-573-4439     Leila_Smaga@meei.harvard.edu    
Principal Investigator: Reza Dana, M.D., MPH            
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Reza Dana, M.D., MPH Massachusetts Eye and Ear Infirmary
  More Information

No publications provided by Massachusetts Eye and Ear Infirmary

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Massachusetts Eye & Ear Infirmary ( Reza Dana, Principal Investigator )
Study ID Numbers: 06-12-077, 06-12-077
Study First Received: November 14, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00559936     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Corneal Diseases
Antineoplastic Agents
Eye Diseases
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Corneal Neovascularization
Angiogenesis Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Metaplasia
Neovascularization, Pathologic
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010