Ranibizumab for the Inhibition of Neovascularization in Pterygia
Information source: Bascom Palmer Eye Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pterygium
Intervention: ranibizumab (Drug); ranibizumab (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bascom Palmer Eye Institute Official(s) and/or principal investigator(s): Sonia Yoo, MD, Principal Investigator, Affiliation: Bascom Palmer Eye Institute
Summary
The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab
given via subconjunctival injection in patients undergoing pterygium surgery.
Clinical Details
Official title: Ranibizumab for the Inhibition of Neovascularization in Pterygia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.
Secondary outcome: This study aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection and determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.
Detailed description:
As a secondary objective, this study also aims to establish the tissue concentration of
ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium
excision and to determine the effects of ranibizumab on conjunctival healing, corneal
epithelial healing, and wound dehiscence.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study
- Age > 18 years
- Patient related considerations: All patients of both genders will be considered for
enrollment.
- Disease related considerations:
- Patients with pterygia will be considered for enrollment if the pterygium meets
standard pterygium excision criteria including encroachment into the visual axis
- severe induced astigmatism
- foreign body sensation unresponsive to medical therapy.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy (positive pregnancy test)
- Women seeking to become pregnant
- Lactating women
- Prior enrollment in the study
- Prior glaucoma surgery in the region of the pterygium
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Locations and Contacts
Bascom Palmer Eye Institute, Miami, Florida 33136, United States
Additional Information
Starting date: October 2008
Last updated: July 24, 2012
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