Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
This study is currently recruiting participants.
Verified January 2013 by The University of Texas Health Science Center, Houston
Sponsor:
The University of Texas Health Science Center, Houston
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: January 16, 2013
Last verified: January 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115517
Locations
| United States, Texas | |
| 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 | |
| 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 | |
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: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pterygium Conjunctival Diseases Eye Diseases Mitomycins Mitomycin Bevacizumab Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013