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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

Page last updated: August 23, 2015

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