Ranibizumab for the Inhibition of Neovascularization in Pterygia - Full Text View

Sponsored by:	Bascom Palmer Eye Institute
Information provided by:	Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:	NCT00768963

Purpose

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

Condition	Intervention	Phase
Pterygium	Drug: ranibizumab	Phase I

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Ranibizumab for the Inhibition of Neovascularization in Pterygia

Further study details as provided by Bascom Palmer Eye Institute:

Primary Outcome Measures:

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients will receive one injection of ranibizumab 3 days prior to surgery	Drug: ranibizumab 0.5 mg subconjunctival ranibizumab 3 days prior to surgery
2: Experimental Patients will undergo one injection of ranibizumab at the time of surgery	Drug: ranibizumab 0.5 mg subconjunctival ranibizumab at the time of 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768963

Contacts

Contact: Sonia Yoo, MDq	(305) 326-6322	syoo@med.miami.edu
Contact: Maria Esquiabro	(305) 326-6508	mesquiabro@med.miami.edu

Locations

United States, Florida
Bascom Palmer Eye Institute	Recruiting
Miami, Florida, United States, 33136
Contact: Sonia Yoo, MD 305-326-6322 syoo@med.miami.edu
Contact: Maria Esquiabro (305) 326-6508 mesquiabro@med.miami.edu
Sub-Investigator: Anat Galor, MD
Sub-Investigator: Victor Perez, MD
Sub-Investigator: Artur Schmitt, MD
Sub-Investigator: Fernanda Piccoli, MD

Sponsors and Collaborators

Bascom Palmer Eye Institute

Investigators

Principal Investigator:

Sonia Yoo, MD

Bascom Palmer Eye Institute

More Information

Responsible Party:	Bascom Palmer Eye Institute ( Sonia Yoo )
Study ID Numbers:	20080012
Study First Received:	October 7, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00768963
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bascom Palmer Eye Institute:

ranibizumab
pterygium

Study placed in the following topic categories:

Eye Diseases
Metaplasia
Pterygium of the conjunctiva

Neovascularization, Pathologic
Pterygium
Conjunctival Diseases

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009