A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00168337

Purpose

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: Dexamethasone Drug: dexamethasone Drug: Sham comparator	Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

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: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

macular thickness [ Time Frame: Month 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	860
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Dexamethasone Dexamethasone 350 µg; injectable implant into intravitreal cavity every 6 months for 36 months Sham injection
2: Active Comparator	Drug: dexamethasone Dexamethasone 700 µg; injectable implant into intravitreal cavity every 6 months for 36 months
3: Sham Comparator	Drug: Sham comparator Sham dexamethasone posterior segment drug delivery system-needleless injection every 6 months

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 diabetic macular edema;
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;
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: NCT00168337

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Irvine, California, United States

Sponsors and Collaborators

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	206207-011
Study First Received:	September 12, 2005
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00168337
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dexamethasone
Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
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
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009