NCT00532415

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of triamcinolone acetonide suspension when used for visualization of structures in the back of the eye during eye surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2007

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

Same day

First QC Date

September 19, 2007

Last Update Submit

April 3, 2012

Conditions

Vitrectomy

Keywords

VitrectomyVisualization

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Visualization Score at Post-Instillation from Pre-Instillation

    A video image of the posterior segment structures of the eye was taken before instillation of the test product and after. An independent masked reader evaluated the images and graded the degree of visualization on a 5-point scale ranging from 1 to 4 and anchored at the ends by "Not Visible (0)" and "Clearly Delineated (4)." The mean difference was calculated, and a higher number indicated increased visibility.

    Day 0

Study Arms (1)

Triamcinolone

EXPERIMENTAL

Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.

Drug: Triamcinolone Acetonide Injectable Suspension

Interventions

Triamcinolone Acetonide Injectable SuspensionDRUG

Approximately 1-4 mg (0.025-0.1 cc) as needed for visualization during pars plana vitrectomy with or without membrane removal.

Triamcinolone

Eligibility Criteria

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

You may qualify if:

  • Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery eye.

You may not qualify if:

  • Patients under 18.
  • Patients with previous vitrectomy, elevated intraocular pressure (IOP) and/or history of ocular inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 20, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 5, 2012

Record last verified: 2012-04