Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-VEGF in Subjects With Wet Age-Related Macular Degeneration - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00775411

Purpose

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

Condition	Intervention	Phase
Choroidal Neovascularization Age-Related Maculopathy	Drug: Dexamethasone as adjunctive therapy to Ranibizumab Injection	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: Macular Degeneration

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

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Mean central retinal thickness by OCT [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best corrected visual acuity [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Fluorescein leakage [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Study Completion Date:	April 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 700 µg Dexamethasone implant in the study eye as adjunctive therapy to Anti-VEGF	Drug: Dexamethasone as adjunctive therapy to Ranibizumab Injection 700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye. Ranibizumab Injection at Week 2 or 3 if BCVA has dropped from baseline. Starting at Week 4, Ranibizumab Injection may be given at the investigator's discretion. Other Name: Posurdex as adjunctive therapy to Lucentis®

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

50 years of age or older with active subfoveal CNV secondary to AMD
Central retinal thickness ≥ 300 µm
Visual acuity between 20/400 and 20/32
Eligible for Anti-VEGF therapy

Exclusion Criteria:

Previous treatment for CNV due to AMD
High eye pressure
Glaucoma
Uncontrolled systemic disease
Known allergy to the study medications
Recent eye surgery or injections in the eye
Female subjects that are of childbearing potential

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775411

Locations

United States, Texas

San Antonio, Texas, United States
Australia, New South Wales

Sydney, New South Wales, Australia
Philippines

Manila, Philippines

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:	NCT00775411 History of Changes
Other Study ID Numbers:	206207-019
Study First Received:	October 16, 2008
Last Updated:	September 24, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal 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

ClinicalTrials.gov processed this record on February 09, 2012