Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
at 26 weeks and yearly through completion of the study

Study Arms (2)

Fluocinolone acetonide

EXPERIMENTAL

Fluocinolone acetonide intravitreal implant

Drug: fluocinolone acetonide

Standard of Care

ACTIVE COMPARATOR

Standard of care

Procedure: Standard of Care

Interventions

fluocinolone acetonideDrug

fluocinolone acetonide 0.59 mg intravitreal implant

Fluocinolone acetonide

Standard of CareProcedure

Repeat macular grid laser or observation

Standard of Care

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and nonpregnant females at least 18 years of age, with DME in the study eye
Edema must involve fixation and be at least 1 disc area in size

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Related Publications (1)

Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
PMID: 16690128BACKGROUND

MeSH Terms

Interventions

Fluocinolone AcetonideStandard of Care

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

Laura Trusso
Bausch & Lomb Incorporated
STUDY DIRECTOR

Enrollment

196 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Study Start

September 2001

Date type not reported

This date has not been verified as actual or estimated.

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Fluocinolone acetonide

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Fluocinolone acetonide

Standard of Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record