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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00768963
Other study ID # 20080012
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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