Ranibizumab for the Inhibition of Neovascularization in Pterygia

Pterygium Clinical Trial

Official title:

Ranibizumab for the Inhibition of Neovascularization in Pterygia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768963
• Other study ID #: 20080012
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2008
• Last updated: July 7, 2017
• Start date: October 2008
• Est. completion date: January 2012

Study information

• Verified date: July 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Pterygium

Intervention

Drug:
• ranibizumab
0.5 mg subconjunctival ranibizumab 3 days prior to surgery
• ranibizumab
0.5 mg subconjunctival ranibizumab at the time of surgery

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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