Trial Outcomes & Findings for Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization (NCT NCT00512876)

NCT ID: NCT00512876

Last Updated: 2013-07-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2013-07-22

Participant Flow

Participants were recruited from the Ophthalmology Service at Walter Reed Army Medical Center, Washington DC from August 2007 to January 2011

Participant milestones

Measure	Topical Avastin 1.0% Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Baseline characteristics by cohort

Measure	Topical Avastin 1.0% n=24 Participants Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age Continuous	52.3 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Topical Avastin 1.0% n=20 Participants Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
Adverse Events (Ocular and Systemic)	0 participants

SECONDARY outcome

Timeframe: 24 weeks

computerized image analysis of the corneal photographs were used to measure the change in size and extent of corneal neovascularization from baseline.

Outcome measures

Measure	Topical Avastin 1.0% n=20 Participants Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
Size and Extent of Corneal Neovascularization	27.9 percentage change Standard Deviation 9.2

Adverse Events

Topical Avastin 1.0%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

U.S. Army Warfighter Refractive Surgery Research Center

Phone: 571-231-1600

Email: rose.sia@us.army.mil

Results disclosure agreements

• Principal investigator is a sponsor employee All materials that reflects the WRAMC affiliation must be approved and properly cleared before the material is submitted for public dissemination and publication. All publications whereby WRAMC is cited in the bylines will state on the cover page the following sample disclaimer: "The views expressed in this \[article, book chapter, speech, presentation, etc.\] are those of the author(s) and do not reflect the official policy of the Department of Army, Department of Defense, or U.S. Government."
• Publication restrictions are in place

Restriction type: OTHER