Pterygium
Conditions
Keywords
ranibizumab, pterygium
Brief 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.
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.
Interventions
DRUGranibizumab
0.5 mg subconjunctival ranibizumab 3 days prior to surgery
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 2 years |
Countries
United States
Outcome results
None listed