Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

Choroidal Neovascularization Clinical Trial

Official title:

A Prospective Investigation of the Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417703
• Other study ID #: 2006032
• Status: Completed
• Phase: Phase 4
• First received: January 3, 2007
• Last updated: January 22, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. With more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. This data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections.

We hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.

Description:

We will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 mL) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. This study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or Female Patients >18 years of age

2. Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography

3. Requiring treatment or maintenance therapy for choroidal neovascular membrane

4. Able and willing to provide written informed consent

Exclusion Criteria:

1. History of arterial occlusive disease of the eye.

2. History of advanced glaucoma.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic

Locations

Country	Name	City	State
United States	Retina Support Services, Inc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States,