Ranibizumab for the Inhibition of Neovascularization in Pterygia

NCT00768963 | Completed Phase 1

• 1 other identifier: 20080012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium

Keywords

ranibizumab; pterygium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: ranibizumab

2

EXPERIMENTAL

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

Drug: ranibizumab

Interventions

ranibizumab DRUG

0.5 mg subconjunctival ranibizumab 3 days prior to surgery

Also known as: Lucentis

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 20417925 DERIVED

MeSH Terms

Conditions

Pterygium

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sonia Yoo, MD

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (1)