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Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

This study has been completed.
Sponsor:
Collaborator:
Hermann Eye Center
Information provided by (Responsible Party):
Nan Wang, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01115517
First received: April 30, 2010
Last updated: September 7, 2016
Last verified: September 2016
Results First Received: March 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pterygium
Interventions: Drug: Bevacizumab
Drug: Mitomycin C

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
51 participants were consented and screened for this study, however only 39 of the 51 met eligibility criteria and were randomized.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Bevacizumab   Mitomycin C
STARTED   18   21 
COMPLETED   14   16 
NOT COMPLETED   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Bevacizumab   Mitomycin C   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   21   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (11)   43.9  (9.4)   49.3  (11.7) 
Gender 
[Units: Participant]
     
Female   10   8   18 
Male   8   13   21 


  Outcome Measures
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1.  Primary:   Number of Participants Who Had Recurrence of Pterygia up to 1 Year   [ Time Frame: 1 year ]

2.  Secondary:   Number of Participants Who Had Complications From the Time of Treatment to Recurrence   [ Time Frame: 1 year ]

3.  Secondary:   Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Nan Wang
Organization: Robert Cizik Eye Clinic
phone: 713-559-5200
e-mail: nwang@cizikeye.org



Responsible Party: Nan Wang, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01115517     History of Changes
Other Study ID Numbers: Pterygium Avastin study
Study First Received: April 30, 2010
Results First Received: March 2, 2016
Last Updated: September 7, 2016
Health Authority: United States: Food and Drug Administration