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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00511706
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : September 3, 2012
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Choroidal Neovascularization Age-Related Maculopathy Drug: dexamethasone Biological: ranibizumab Other: sham Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : November 1, 2007
Actual Primary Completion Date : March 1, 2009
Actual Study Completion Date : March 1, 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: dexamethasone and ranibizumab
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
 Drug: dexamethasone
Intravitreal injection of dexamethasone 700 µg at Day 1.
Other Name: Posurdex

Biological: ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
Other Name: Lucentis®
Sham Comparator: sham and ranibizumab
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
 Biological: ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
Other Name: Lucentis®

Other: sham
Sham needle-less injection administered in the study eye at Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Injection Free Interval [ Time Frame: Week 1 to Week 25 ]
    The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.


Secondary Outcome Measures :
  1. Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 [ Time Frame: Baseline, Week 25 ]
    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.

  2. Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye [ Time Frame: Baseline, Week 25 ]
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.

  3. Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye [ Time Frame: Screening (-Week 28), Week 25 ]
    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 Screening and Week 25.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 50 years of age or older with subfoveal choroidal neovascularization (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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511706


Locations
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United States, Florida
Boynton Beach, Florida, United States
Australia, New South Wales
Parramatta, New South Wales, Australia
France
Paris, France
Israel
Tel Aviv, Israel
Italy
Milano, Italy
Korea, Republic of
Seoul, Korea, Republic of
New Zealand
Auckland, New Zealand
Portugal
Coimbra, Portugal
United Kingdom
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00511706    
Other Study ID Numbers: 206207-016
First Posted: August 6, 2007    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases
Retinal Degeneration
Retinal Diseases
Dexamethasone
Ranibizumab
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors