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Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

This study has been terminated.
(The study was terminated early due to difficulties with patient recruitment.)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01122511
First received: May 11, 2010
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration


Condition Intervention Phase
Subfoveal Choroidal Neovascularization
Age-Related Maculopathy
 Drug: 700 ug dexamethasone
Biological: ranibizumab
Other: sham
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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 Best Corrected Visual Acuity (BCVA) at Month 12 [ Time Frame: Baseline, Month 12 ] [ 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.


Secondary Outcome Measures:
  • The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 [ Time Frame: Baseline, Month 12 ] [ 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.

  • Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography [ Time Frame: Baseline, Month 12 ] [ 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 Month 12.

  • Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography [ Time Frame: Baseline, Month 12 ] [ 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 was performed on the study eye after dilation at baseline and Week 12.


Enrollment: 4
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 ug dexamethasone and ranibizumab
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
 Drug: 700 ug dexamethasone
Intravitreal injection of 700 ug dexamethasone into study eye
Other Name: OZURDEX®
Biological: ranibizumab
Intravitreal injection of ranibizumab into study eye
Other Name: Lucentis®
Active Comparator: ranibizumab and sham
Intravitreal injection of ranibizumab and Sham into study eye
 Biological: ranibizumab
Intravitreal injection of ranibizumab into study eye
Other Name: Lucentis®
Other: sham
Sham needle-less injection administered in the study eye

  Eligibility

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

Inclusion Criteria:

  • Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
  • Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
  • Visual acuity between 20/320 and 20/40

Exclusion Criteria:

  • Active ocular infection
  • Contraindication to pupil dilation in either eye
  • Eye surgery including cataract surgery and/or laser of any type within 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122511

Locations
United States, Florida
Fort Myers, Florida, United States
United States, Texas
Abilene, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01122511     History of Changes
Other Study ID Numbers: 206207-021
Study First Received: May 11, 2010
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
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 May 19, 2013