Ranibizumab for the Inhibition of Neovascularization in Pterygia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Yoo, Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:
NCT00768963
First received: October 7, 2008
Last updated: July 24, 2012
Last verified: July 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab for the Inhibition of Neovascularization in Pterygia

Resource links provided by NLM:


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 ]

Enrollment: 10
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive one injection of ranibizumab 3 days prior to surgery
Drug: ranibizumab
0.5 mg subconjunctival ranibizumab 3 days prior to surgery
Other Name: Lucentis
Experimental: 2
Patients will undergo one injection of ranibizumab at the time of surgery
Drug: ranibizumab
0.5 mg subconjunctival ranibizumab at the time of surgery
Other Name: Lucentis

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
Bascom Palmer Eye Institute
Investigators
Principal Investigator: Sonia Yoo, MD Bascom Palmer Eye Institute
  More Information

No publications provided by Bascom Palmer Eye Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia Yoo, Professor, Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier: NCT00768963     History of Changes
Other Study ID Numbers: 20080012
Study First Received: October 7, 2008
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bascom Palmer Eye Institute:
ranibizumab
pterygium

Additional relevant MeSH terms:
Neovascularization, Pathologic
Pterygium
Metaplasia
Pathologic Processes
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014