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Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417703
First Posted: January 4, 2007
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oklahoma State University Center for Health Sciences
  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:


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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00417703     History of Changes
Other Study ID Numbers: 2006032
First Submitted: January 3, 2007
First Posted: January 4, 2007
Last Update Posted: January 24, 2008
Last Verified: January 2008

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
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents