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Bevacizumab for Primary Pterygium Treatment

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ClinicalTrials.gov Identifier: NCT01686529
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date December 6, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
Pterygium recurrence [ Time Frame: One point. ]
The pterygium recurrence is evaluated at one year postoperative
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01686529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
Conjunctival ischemia [ Time Frame: Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative ]
Whiteness of conjunctival bed, that means absence of blood vessels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab for Primary Pterygium Treatment
Official Title  ICMJE Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.
Brief Summary The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Pterygium
Intervention  ICMJE
  • Procedure: Autoconjunctival grafting
    The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.
  • Drug: Subconjuntival bevacizumab injection
    The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.
    Other Name: Avastin
Study Arms  ICMJE
  • Experimental: One subconjunctival injection
    Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
    Interventions:
    • Procedure: Autoconjunctival grafting
    • Drug: Subconjuntival bevacizumab injection
  • Experimental: Two subconjuctival injections
    Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
    Interventions:
    • Procedure: Autoconjunctival grafting
    • Drug: Subconjuntival bevacizumab injection
  • Active Comparator: Conventional treatment
    Autoconjunctival grafting without subconjuntival bevacizumab injection
    Intervention: Procedure: Autoconjunctival grafting
Publications * Nava-Castañeda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2012)
49
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with primary pterygium

Exclusion Criteria:

  • Patients with diabetes mellitus
  • collagenopathies,
  • previous ocular surgeries,
  • pregnant or lactating patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686529
Other Study ID Numbers  ICMJE CC-008-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Oftalmología Fundación Conde de Valenciana
Study Sponsor  ICMJE Instituto de Oftalmología Fundación Conde de Valenciana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yonathan Garfias, MD, PhD Instituto de Oftalmología
PRS Account Instituto de Oftalmología Fundación Conde de Valenciana
Verification Date December 2013

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