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

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00511706

Purpose

The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Condition	Intervention	Phase
Choroidal Neovascularization Age-Related Maculopathy	Drug: Dexamethasone and ranibizumab Other: Sham injection and ranibizumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

Time to retreat with ranibizumab [ Time Frame: 1-6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Central Retinal Thickness (OCT) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Lesion size (FA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Enrollment:	243
Study Start Date:	November 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental adjunctive therapy of experimental with ranibizumab	Drug: Dexamethasone and ranibizumab Intravitreal injection of Dexamethasone 700µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14
2: Sham Comparator adjunctive therapy of sham (for masking) and ranibizumab	Other: Sham injection and ranibizumab sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14

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 subfoveal CNV (classic and/or occult) secondary to AMD
Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria:

Any intraocular surgery within 3 months
Glaucoma
Cataract
High eye pressure
Uncontrolled systemic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511706

Locations

United States, Florida

Boyton Beach, Florida, United States
Australia, New South Wales

Sydney, New South Wales, Australia
Israel, Gush Dan

Tel Aviv, Gush Dan, Israel

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	206207-016
Study First Received:	August 2, 2007
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00511706 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Uveal Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Eye Diseases
Choroid Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Macular Degeneration
Retinal Degeneration

Antiemetics
Bevacizumab
Hormones
Glucocorticoids
Choroidal Neovascularization
Metaplasia
Peripheral Nervous System Agents
Neovascularization, Pathologic
Retinal Diseases
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Pathologic Processes
Metaplasia
Therapeutic Uses
Dexamethasone acetate
Retinal Diseases
Uveal Diseases

Antineoplastic Agents, Hormonal
Eye Diseases
Choroid Diseases
Gastrointestinal Agents
Retinal Degeneration
Macular Degeneration
Glucocorticoids
Pharmacologic Actions
Choroidal Neovascularization
Autonomic Agents
Neovascularization, Pathologic
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009