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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 243
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511706

Locations
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
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00511706     History of Changes
Other Study ID Numbers: 206207-016
Study First Received: August 2, 2007
Results First Received: August 1, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Endothelial Growth Factors
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014