Ranibizumab for the Inhibition of Neovascularization in Pterygia

Phase 1

Completed

• Conditions: Pterygium
• Interventions: Drug: ranibizumab

• Registration Number: NCT00768963
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ranibizumab	Patients will receive one injection of ranibizumab 3 days prior to surgery
2	ranibizumab	Patients will undergo one injection of ranibizumab at the time of surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States