Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus Macular Edema

Outcome Measures

Primary Outcomes (7)

Mean Change in Best Corrected Visual Acuity
1 months
Mean Change in Best Corrected Visual Acuity
2 months
Mean Change in Best Corrected Visual Acuity
3 months
Mean Change in Central Retinal Thickness
1 month
Mean Change in Central Retinal Thickness
2 months
Mean Change in Central Retinal Thickness
3 months
Mean Change in Intraocular Pressure

Study Arms (2)

OZURDEX intraocular implant

EXPERIMENTAL

OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg

Drug: Dexamethasone intravitreal implant

Steroid plus NSAID eye drop combination therapy

ACTIVE COMPARATOR

NSAID eye drop: Acular LS Steriod eye drop: Pred Forte

Drug: Steroid plus NSAID eye drop combination therapy

Interventions

Dexamethasone intravitreal implantDrug

Also known as: OZURDEX

OZURDEX intraocular implant

Steroid plus NSAID eye drop combination therapyDrug

Also known as: Acular LS and Pred Forte

Steroid plus NSAID eye drop combination therapy

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patient has diagnosis of Diabetes Mellitus, Type I or II.
Patient has experienced the development of macular edema following cataract surgery in at least one eye.

Sponsors & Collaborators

Retinal Consultants of Arizona
Otherlead
Allergan
Industrycollaborator

Study Sites (1)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

MeSH Terms

Conditions

Macular EdemaDiabetes Mellitus

Interventions

DexamethasoneCalcium DobesilateSteroidsKetorolacprednisolone acetate

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.

Results Point of Contact

Title: Dr. Pravin Dugel
Organization: Retinal Consultants of Arizona

Study Officials

Pravin U Dugel, MD
Retinal Consultants of Arizona
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 27, 2012

Study Start

November 2012

Date type not reported

This date has not been verified as actual or estimated.

A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (7)

Study Arms (2)

OZURDEX intraocular implant

Steroid plus NSAID eye drop combination therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (7)

Study Arms (2)

OZURDEX intraocular implant

Steroid plus NSAID eye drop combination therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations