Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

April 30, 2010
September 7, 2016
October 2010
July 2015   (final data collection date for primary outcome measure)
Number of Participants Who Had Recurrence of Pterygia up to 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Efficacy of bevacizumab as adjunctive therapy during pterygium surgery to prevent recurrence of pterygia. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety of intraoperative bevacizumab applied as adjunctive therapy during pterygium surgery. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01115517 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Had Complications From the Time of Treatment to Recurrence [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Complication rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Elapsed time to recurrence of pterygia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Risk factors for pterygium recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pterygium
  • Drug: 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.
    Other Name: Bevacizumab (Avastin)
  • Drug: 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.
  • Experimental: Bevacizumab
    Intervention: Drug: Bevacizumab
  • Active Comparator: Mitomycin C
    Intervention: Drug: Mitomycin C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 80
  • Presence of primary or recurrent pterygium
  • Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
  • Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
  • The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)

Exclusion Criteria:

  • Age less than 18
  • Age greater than 80
  • Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
  • Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
  • Any use within the past two months of topical eye drops other than artificial tears in the study eye
  • Any previous intravitreal injections of any medication in the study eye
  • Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
  • Any history of subconjunctival injections in the study eye within the past year
  • Any history of scleral or corneal laceration in the study eye
  • Ocular surgery within the past 3 months in the study eye
  • History of scleral buckle placement in the study eye
  • History of glaucoma
Both
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01115517
Pterygium Avastin study
No
Not Provided
Not Provided
Nan Wang, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Hermann Eye Center
Principal Investigator: Nan Wang, MD, PhD University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
The University of Texas Health Science Center, Houston
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP