A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion - Full Text View

Purpose

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Condition	Intervention	Phase
Macular Edema Retinal Vein Occlusion	Drug: Dexamethasone Other: Sham injection	Phase III

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Edema

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Visual acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
Contrast sensitivity [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
Macular thickness (OCT) [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
Vessel leakage (FA) [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Months 1- 12 ] [ Designated as safety issue: No ]

Enrollment:	600
Study Start Date:	November 2004
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Dexamethasone 700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline and month 6
2: Active Comparator	Drug: Dexamethasone 350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity at baseline
3: Sham Comparator	Other: Sham injection Sham injection at baseline

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

18 years of age or older with macular edema resulting from retinal vein occlusion
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

Known anticipated need for ocular surgery within next 12 months
History of glaucoma or current high eye pressure requiring more than 1 medication
Diabetic retinopathy
Uncontrolled systemic disease
Known steroid-responder
Use of systemic steroids
Use of warfarin/heparin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168298

Locations


United States, Texas

	Houston, Texas, United States

Canada, Ontario

	Mississauga, Ontario, Canada

United Kingdom

	London, United Kingdom

Sponsors and Collaborators

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	206207-009
First Received:	September 12, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00168298
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone

Eye Diseases

Vascular Diseases

Edema

Macular Degeneration

Retinal Degeneration

Thrombosis

Macular Edema

Signs and Symptoms

Embolism and Thrombosis

Embolism

Retinal Vein Occlusion

Venous Thrombosis

Dexamethasone acetate

Retinal Diseases

Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Cardiovascular Diseases

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00168298