search
Back to results

Ranibizumab for the Inhibition of Neovascularization in Pterygia

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
ranibizumab
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring ranibizumab, pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bascom Palmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Patients will receive one injection of ranibizumab 3 days prior to surgery

Patients will undergo one injection of ranibizumab at the time of surgery

Outcomes

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.

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.

Full Information

First Posted
October 7, 2008
Last Updated
July 7, 2017
Sponsor
University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT00768963
Brief Title
Ranibizumab for the Inhibition of Neovascularization in Pterygia
Official Title
Ranibizumab for the Inhibition of Neovascularization in Pterygia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
ranibizumab, pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive one injection of ranibizumab 3 days prior to surgery
Arm Title
2
Arm Type
Experimental
Arm Description
Patients will undergo one injection of ranibizumab at the time of surgery
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg subconjunctival ranibizumab 3 days prior to surgery
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5 mg subconjunctival ranibizumab at the time of surgery
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Yoo, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20417925
Citation
Galor A, Yoo SH, Piccoli FV, Schmitt AJ, Chang V, Perez VL. Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery. Am J Ophthalmol. 2010 Jun;149(6):926-931.e2. doi: 10.1016/j.ajo.2010.01.015. Epub 2010 Apr 24.
Results Reference
derived

Learn more about this trial

Ranibizumab for the Inhibition of Neovascularization in Pterygia

We'll reach out to this number within 24 hrs