Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

NCT01115517 | Completed Phase 2 Results

• 1 other identifier: Pterygium Avastin study
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pterygium

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Recurrence of Pterygia up to 1 Year

  1 year

Secondary Outcomes (2)

• Number of Participants Who Had Complications From the Time of Treatment to Recurrence

  1 year

• Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year

  1 year

Study Arms (2)

Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab

Mitomycin C

ACTIVE COMPARATOR

Drug: Mitomycin C

Interventions

Bevacizumab DRUG

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.

Also known as: Bevacizumab (Avastin)

Bevacizumab

Mitomycin C DRUG

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.

Mitomycin C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Hermann Eye Center: collaborator

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pterygium

Interventions

Bevacizumab; Mitomycin

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Nan Wang
• Organization: Robert Cizik Eye Clinic

nwang@cizikeye.org

713-559-5200

Study Officials

• Nan Wang, MD, PhD

  University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor - Ophthalmology

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 21, 2016
• Results First Posted: September 2, 2016

Record last verified: 2016-09

Locations

US (2)