Trial Outcomes & Findings for Topical Avastin for Treatment of Corneal Neovascularization (NCT NCT00559936)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Six Months

Results posted on

2022-04-29

Participant Flow

Participants were recruited from the Cornea Service at Massachusetts Eye and Ear Infirmary from February 2007 through October 2010.

Only patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.

Participant milestones

Participant milestones
Measure	Topical Avastin 1.0% Each patient will receive topical Avastin in one eye.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Avastin for Treatment of Corneal Neovascularization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topical Avastin 1.0% n=24 Participants Each patient will receive topical Avastin in one eye.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 3.3 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Region of Enrollment United States	24 participants n=99 Participants

PRIMARY outcome

Timeframe: Six Months

Population: Participants who received investigational treatment were analyzed.

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.

Outcome measures

Outcome measures
Measure	Topical Avastin 1.0% n=20 Participants Each patient will receive topical Avastin in one eye.
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.	27.9 percent change since baseline Standard Deviation 9.2

PRIMARY outcome

Timeframe: All study visits

Population: Participants treated with investigational medication were analyzed.

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.

Outcome measures

Outcome measures
Measure	Topical Avastin 1.0% n=20 Participants Each patient will receive topical Avastin in one eye.
Ocular and Systemic Safety	0 participants

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

Dr. Reza Dana

Massachusetts Eye and Ear Infirmary

Phone: 617-573-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place