ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

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: NCT00775411
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : April 2010


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 [ Time Frame: Baseline, Week 4 ]
    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 :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 [ Time Frame: Baseline, Week 26 ]
    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.

  2. 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 ]
    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%).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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

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): 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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00775411     History of Changes
Other Study ID Numbers: 206207-019
First Posted: October 20, 2008    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012

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
Ranibizumab
BB 1101
Endothelial Growth Factors
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors