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Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115517
First Posted: May 4, 2010
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hermann Eye Center
Information provided by (Responsible Party):
Nan Wang, The University of Texas Health Science Center, Houston
  Purpose
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.

Condition Intervention Phase
Pterygium Drug: Bevacizumab Drug: Mitomycin C Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery

Resource links provided by NLM:


Further study details as provided by Nan Wang, The University of Texas Health Science Center, Houston:

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

Secondary Outcome Measures:
  • Number of Participants Who Had Complications From the Time of Treatment to Recurrence [ Time Frame: 1 year ]
  • Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year [ Time Frame: 1 year ]

Enrollment: 51
Study Start Date: October 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab 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)
Active Comparator: Mitomycin C 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115517


Locations
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Hermann Eye Center
Investigators
Principal Investigator: Nan Wang, MD, PhD University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
  More Information

Responsible Party: Nan Wang, Clinical Associate Professor - Ophthalmology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01115517     History of Changes
Other Study ID Numbers: Pterygium Avastin study
First Submitted: April 30, 2010
First Posted: May 4, 2010
Results First Submitted: March 2, 2016
Results First Posted: September 2, 2016
Last Update Posted: October 21, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Mitomycins
Mitomycin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors