Trial Outcomes & Findings for Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery (NCT NCT01115517)

NCT ID: NCT01115517

Last Updated: 2016-10-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2016-10-21

Participant Flow

51 participants were consented and screened for this study, however only 39 of the 51 met eligibility criteria and were randomized.

Participant milestones

Measure	Bevacizumab Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.	Mitomycin C Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Overall Study STARTED	18	21
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

Baseline characteristics by cohort

Measure	Bevacizumab n=18 Participants Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.	Mitomycin C n=21 Participants Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.	Total n=39 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 11 • n=5 Participants	43.9 years STANDARD_DEVIATION 9.4 • n=7 Participants	49.3 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Bevacizumab n=14 Participants Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.	Mitomycin C n=16 Participants Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Number of Participants Who Had Recurrence of Pterygia up to 1 Year	0 participants	3 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Bevacizumab n=14 Participants Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.	Mitomycin C n=16 Participants Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Number of Participants Who Had Complications From the Time of Treatment to Recurrence	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Bevacizumab n=14 Participants Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.	Mitomycin C n=16 Participants Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year	0 participants	0 participants

Adverse Events

Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mitomycin C

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. Nan Wang

Robert Cizik Eye Clinic

Phone: 713-559-5200

Email: nwang@cizikeye.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place