Trial Outcomes & Findings for Treatment of Corneal Neovascularization With Topical Pazopanib (NCT NCT01257750)

Results Overview

Heart rate through was measured throughout the study to assess subjects for systemic adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

12 Weeks

Results posted on

2018-01-18

Participant Flow

Patients were recruited and consented at the Massachusetts Eye and Ear Infirmary Cornea Department from November 2010 - October 2011.

Participant milestones

Participant milestones
Measure	Pazopanib This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Corneal Neovascularization With Topical Pazopanib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Age, Continuous	54 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Mean Arterial Pressure	92.0 mm Hg STANDARD_DEVIATION 1.7 • n=5 Participants
Heart Rate	70.4 Beats per Minute STANDARD_DEVIATION 8.1 • n=5 Participants
Intraocular Pressure	15.7 mm Hg STANDARD_DEVIATION 5.9 • n=5 Participants
Central Corneal Thickness	572 microns STANDARD_DEVIATION 135 • n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: All enrolled patients were analyzed.

Heart rate through was measured throughout the study to assess subjects for systemic adverse events.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Heart Rate	68.7 Beats per Minutes Standard Deviation 7.6

PRIMARY outcome

Timeframe: 12 Weeks

Mean arterial pressure was measured throughout the study to assess subjects for systemic adverse events..

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Mean Arterial Pressure	90.7 mmHG Standard Deviation 1.4

PRIMARY outcome

Timeframe: 12 Weeks

Population: All enrolled patients were analyzed.

Pachymetry was used to measure the central corneal thickness of each study subject. Central corneal thickness was measured throughout the study to assess subjects for ocular adverse events.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Central Corneal Thickness	590 Microns Standard Deviation 162

PRIMARY outcome

Timeframe: 12 Weeks

Intaocular pressure is the measurement of pressure within the eye. Intaocular pressure was measured throughout the study to assess subjects for ocular adverse events.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Intaocular Pressure	16.9 mmHg Standard Deviation 5.3

SECONDARY outcome

Timeframe: Through 12 weeks of Follow-Up

Population: Mean Change in Corneal Neovascular Area (measuring the area of the corneal vessels) from Baseline to 12 Week Time Point.

Corneal neovascular area is the measurement of the area of the cornea where new blood vessels are forming. The mean Change in Corneal Neovascular Area from Baseline to 12 Week Time Point is reported below.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Corneal Neovascular Area	1.5 millimeters squared Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 Weeks

Corneal Invasion area is the measurement of the fraction of the total corneal area that is invaded by blood vessels. The mean Change in Corneal invasion area from baseline to 12 Week Time Point is reported below.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Corneal Invasion Area	3.9 millimeters squared Standard Deviation 1.8

SECONDARY outcome

Timeframe: 12 Weeks

Corneal vessel length is the measurement of the length of the extent of vessels from end to end. The mean change in corneal vessel length from Baseline to 12 Week Time Point is reported below.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Corneal Vessel Length	38.0 millimeters Standard Deviation 17.2

SECONDARY outcome

Timeframe: 12 Weeks

Corneal vessel caliber is the measurement of the diameter of the corneal blood vessels. The mean change in the corneal vessel caliber from baseline to 12 week time point is reported below.

Outcome measures

Outcome measures
Measure	Pazopanib n=20 Participants This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Corneal Vessel Caliber	0.0003 millimeters Standard Deviation 0.0005

Adverse Events

Pazopanib

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pazopanib n=20 participants at risk This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye. Frequency and Duration: 4 times per day for 3 weeks
Eye disorders Tearing	50.0% 10/20 • Number of events 13
Eye disorders Stinging	20.0% 4/20 • Number of events 4
Eye disorders Dryness	5.0% 1/20 • Number of events 1
Eye disorders Blurred Vision	5.0% 1/20 • Number of events 1

Additional Information

Reza Dana, MD, MPH, MSc

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