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Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00417703
First received: January 3, 2007
Last updated: January 22, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Phase
Choroidal Neovascularization
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Investigation of the Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Oklahoma State University Center for Health Sciences:

Estimated Enrollment: 75
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417703

Locations
United States, Oklahoma
Retina Support Services, Inc
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Scott J Westhouse, DO Oklahoma State University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00417703     History of Changes
Other Study ID Numbers: 2006032
Study First Received: January 3, 2007
Last Updated: January 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
Intraocular Pressure
Intravitreous Injection
Ranibizumab

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Metaplasia
Pathologic Processes
 Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013