Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

Between group difference in mean visual acuity change (from baseline)
1 year

Secondary Outcomes (2)

Differences in the proportions of subjects in each treatment group experiencing changes in: the area of retinal thickening; retinal leakage and cystoid scores; grade of diabetic retinopathy
1 year
Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg
throughout study

Study Arms (3)

Fluocinolone acetonide 0.59 mg

EXPERIMENTAL

0.59 mg fluocinolone acetonide intravitreal implant

Drug: 0.59 mg fluocinolone acetonide intravitreal implant

Fluocinolone acetonide 2.1 mg

EXPERIMENTAL

2.1 mg fluocinolone acetonide intravitreal implant

Drug: 2.1 mg fluocinolone acetonide intravitreal implant

Laser photocoagulation

ACTIVE COMPARATOR

standard of care laser photocoagulation

Procedure: standard of care laser photocoagulation

Interventions

0.59 mg fluocinolone acetonide intravitreal implantDrug

0.59 mg

Also known as: Retisert

Fluocinolone acetonide 0.59 mg

2.1 mg fluocinolone acetonide intravitreal implantDrug

2.1 mg

Fluocinolone acetonide 2.1 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 1 or 2 diabetes.
Subjects with clinically significant macular edema as defined by the ETDRS.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (2)

The Chinese University of Hong Kong

Hong Kong, China

LV Prasad Eye Institute

Banjara Hills, Hyderabad, 500 034, India

MeSH Terms

Interventions

Fluocinolone Acetonide

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

Taraprasad Das, MD
LV Prasad Eye Institute
PRINCIPAL INVESTIGATOR
Dennis Lam Shun-Chiu, MD
Chinese University of Hong Kong
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

March 2003

Date type not reported

This date has not been verified as actual or estimated.

Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With 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)

Secondary Outcomes (2)

Study Arms (3)

Fluocinolone acetonide 0.59 mg

Fluocinolone acetonide 2.1 mg

Laser photocoagulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

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)

Secondary Outcomes (2)

Study Arms (3)

Fluocinolone acetonide 0.59 mg

Fluocinolone acetonide 2.1 mg

Laser photocoagulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations