Trial Outcomes & Findings for The Effect of Bevacizumab (Avastin) on Pterygium (NCT NCT00592176)

Results Overview

Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2014-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Bevacizumab (Avastin) on Pterygium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab n=5 Participants The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: All subjects enrolled were analzyed.

Growth of the pterygium was defined as an increase in the area of the pterygium as measured from the limbus toward the visual axis. This would be a positive change value indicating progression Regression of the pterygium was defined as a decrease in the area of the pterygium length measured from the limbus toward the visual axis. This would be negative change value indicating regression.

Outcome measures

Outcome measures
Measure	Bevacizumab n=5 Participants Patients receiving bevacizumab treatment.
The Area the Pterygium Enlarged or Regressed as Measured From the Limbus Before and After Subconjunctival Bevacizumab Injection.	5.75 area in millimeters squared Standard Deviation 2.91

SECONDARY outcome

Timeframe: 12 months

Population: All subjects enrolled were analzyed.

The number of patients having surgical removal of pterygium within 12 months.

Outcome measures

Outcome measures
Measure	Bevacizumab n=5 Participants Patients receiving bevacizumab treatment.
Number of Patients Having Surgical Removal of Pterygium.	0 Participants

Adverse Events

Bevacizumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bevacizumab n=5 participants at risk The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
Eye disorders Ocular Irritation	20.0% 1/5 • Number of events 1
Eye disorders Pulling at site of injection of avastin	40.0% 2/5 • Number of events 2
Eye disorders Subconjunctival hemorrhage at injection site	20.0% 1/5 • Number of events 1

Additional Information

Dr. Tyler Hall, M.D.

University of Alabama at Birmingham

Phone: 205-325-8310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place