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Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00775411
First received: October 16, 2008
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  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
Biological: ranibizumab
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.


Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

  • Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
    Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).


Enrollment: 44
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: 700 µg dexamethasone and ranibizumab
700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
 Drug: dexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
Other Name: Posurdex
Biological: ranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Other Name: 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 choroidal neovascularization (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: Allergan
ClinicalTrials.gov Identifier: NCT00775411     History of Changes
Other Study ID Numbers: 206207-019
Study First Received: October 16, 2008
Results First Received: August 1, 2012
Last Updated: August 1, 2012
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
Endothelial Growth Factors
 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

ClinicalTrials.gov processed this record on June 17, 2013