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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00511706
First received: August 2, 2007
Last updated: August 1, 2012
Last verified: August 2012

August 2, 2007
August 1, 2012
November 2007
March 2009   (final data collection date for primary outcome measure)
Injection Free Interval [ Time Frame: Week 1 to Week 25 ] [ Designated as safety issue: No ]
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.
Retreatment Frequency
Complete list of historical versions of study NCT00511706 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 [ Time Frame: Baseline, Week 25 ] [ 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) 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.
  • 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 ] [ 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 in the study eye after pupil dilation at baseline and Month 25.
  • 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 ] [ 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 Screening and Week 25.
Variability and Frequency of injections, Visual Acuity, Central Retinal Thickness, CNV lesion size and area of leakage, and patient reported outcomes
Not Provided
Not Provided
 
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)
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Choroidal Neovascularization
  • Age-Related Maculopathy
  • 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®
  • Other: sham
    Sham needle-less injection administered in the study eye at Day 1.
  • Experimental: dexamethasone and ranibizumab
    Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
    Interventions:
    • Drug: dexamethasone
    • Biological: ranibizumab
  • Sham Comparator: sham and ranibizumab
    Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
    Interventions:
    • Biological: ranibizumab
    • Other: sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Portugal,   United Kingdom
 
NCT00511706
206207-016
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