Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas Health Science Center, Houston
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: May 22, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115517

Locations
United States, Texas
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Nan Wang, MD, PhD    713-559-5200    nan.wang@uth.tmc.edu   
Principal Investigator: Nan Wang, MD, PhD         
Robert Cizik Eye Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Nan Wang, MD, PhD    713-559-5200    nan.wang@uth.tmc.edu   
Principal Investigator: Nan Wang, MD, PhD         
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

No publications provided

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
Study First Received: April 30, 2010
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014