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Topical Avastin for Treatment of Corneal Neovascularization

Primary Purpose

Corneal Neovascularization

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topical Avastin 1%
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Neovascularization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical Avastin 1.0%

Arm Description

Each patient will receive topical Avastin in one eye.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2007
Last Updated
April 4, 2022
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT00559936
Brief Title
Topical Avastin for Treatment of Corneal Neovascularization
Official Title
Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Avastin 1.0%
Arm Type
Experimental
Arm Description
Each patient will receive topical Avastin in one eye.
Intervention Type
Drug
Intervention Name(s)
Topical Avastin 1%
Other Intervention Name(s)
bevacizumab
Intervention Description
Avastin (bevacizumab) 1%
Primary Outcome Measure Information:
Title
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.
Description
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.
Time Frame
Six Months
Title
Ocular and Systemic Safety
Description
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.
Time Frame
All study visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, M.D., MPH
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22967868
Citation
Cheng SF, Dastjerdi MH, Ferrari G, Okanobo A, Bower KS, Ryan DS, Amparo F, Stevenson W, Hamrah P, Nallasamy N, Dana R. Short-term topical bevacizumab in the treatment of stable corneal neovascularization. Am J Ophthalmol. 2012 Dec;154(6):940-948.e1. doi: 10.1016/j.ajo.2012.06.007. Epub 2012 Sep 8.
Results Reference
derived
PubMed Identifier
19365012
Citation
Dastjerdi MH, Al-Arfaj KM, Nallasamy N, Hamrah P, Jurkunas UV, Pineda R 2nd, Pavan-Langston D, Dana R. Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study. Arch Ophthalmol. 2009 Apr;127(4):381-9. doi: 10.1001/archophthalmol.2009.18.
Results Reference
derived

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Topical Avastin for Treatment of Corneal Neovascularization

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