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OpenTrials
Completed

NCT Number: NCT00775411

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 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.

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Key information

Conditions

Choroidal Neovascularization Age-Related Maculopathy Choroid Diseases Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

700 µg dexamethasone intravitreal injection at Day 1 in the study eye.

Other names: Posurdex

ranibizumab

Biological

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 names: Lucentis®

Primary outcomes

  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 outcomes

  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%).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 20, 2008
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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