NCT00417703

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

Enrollment Period

1 year

First QC Date

January 3, 2007

Last Update Submit

January 22, 2008

Conditions

Choroidal Neovascularization

Keywords

Intraocular PressureIntravitreous InjectionRanibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female Patients \>18 years of age
  • Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography
  • Requiring treatment or maintenance therapy for choroidal neovascular membrane
  • Able and willing to provide written informed consent

You may not qualify if:

  • History of arterial occlusive disease of the eye.
  • History of advanced glaucoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Support Services, Inc

Tulsa, Oklahoma, 74127, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Scott J Westhouse, DO

    Oklahoma State University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations

US(1)