Topical Avastin for Treatment of Corneal Neovascularization

NCT00559936 | Completed Phase 1 Results

• 1 other identifier: 06-12-077
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (2)

• 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.

  Six Months

• 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.

  All study visits

Study Arms (1)

Topical Avastin 1.0%

EXPERIMENTAL

Each patient will receive topical Avastin in one eye.

Drug: Topical Avastin 1%

Interventions

Topical Avastin 1% DRUG

Avastin (bevacizumab) 1%

Also known as: bevacizumab

Topical Avastin 1.0%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 22967868 DERIVED

• 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.

  PMID: 19365012 DERIVED

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Reza Dana
• Organization: Massachusetts Eye and Ear Infirmary

cornea_research@meei.harvard.edu

617-573-3313

Study Officials

• Reza Dana, M.D., MPH

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cornea and Refractive Surgery Service

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 29, 2022
• Results First Posted: September 24, 2012

Record last verified: 2022-04

Locations

US (1)