Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00799227

Purpose

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Condition	Intervention	Phase
Diabetic Macular Edema Vitrectomy	Drug: Dexamethasone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

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

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from baseline in mean central retinal thickness by optical coherence tomography (OCT) [ Time Frame: Day 1, Weeks 1-26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with at least 10 letters of improvement from baseline in best corrected visual acuity (BCVA) [ Time Frame: Day 1 -Week 26 ] [ Designated as safety issue: No ]
Change from baseline in fluorescein leakage assessed by fluorescein angiography (FA) [ Time Frame: Day 1, Week 26 ] [ Designated as safety issue: No ]
Change from baseline in the scales of the NEI-VFQ-25 [ Time Frame: Weeks 4 - 26 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 700 µg Dexamethasone implant in the study eye	Drug: Dexamethasone 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye. Other Name: Posurdex®

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older with diabetic macular edema, history of vitrectomy, central retinal thickness ≥ 275 µm, visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye.

Exclusion Criteria:

Known anticipated need for ocular surgery during the study period, history of glaucoma or current high eye pressure requiring more than 1 medication, uncontrolled systemic disease, known allergy to the study medication, known steroid-responder, use of systemic steroids, female subjects that are pregnant, nursing or planning a pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799227

Locations

United States, North Carolina

Charlotte, North Carolina, United States
Australia, New South Wales

Sydney, New South Wales, Australia

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00799227 History of Changes
Other Study ID Numbers:	206207-018
Study First Received:	November 26, 2008
Last Updated:	September 24, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012