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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

October 16, 2008
August 1, 2012
November 2008
November 2009   (final data collection date for primary outcome measure)
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.
Mean central retinal thickness by OCT [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00775411 on ClinicalTrials.gov Archive Site
  • 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%).
  • Best corrected visual acuity [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Fluorescein leakage [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
Not Provided

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Choroidal Neovascularization
  • Age-Related Maculopathy
  • 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®
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.
Interventions:
  • Drug: dexamethasone
  • Biological: ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Philippines
 
NCT00775411
206207-019
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP