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

Sponsored by:	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

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, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

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

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Sponsors and Collaborators

Allergan

Investigators

Study Chair:

Medical Director

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	206207-018
Study First Received:	November 26, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00799227
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 16, 2009