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)

April 11, 2019 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Posurdex
Biological: ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
Other Names:
  • 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 Names:
  • Lucentis®
Other: sham
Sham needle-less injection administered in the study eye at Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection Free Interval
Time Frame: Week 1 to Week 25
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.
Week 1 to Week 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25
Time Frame: Baseline, Week 25
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.
Baseline, Week 25
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
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.
Baseline, Week 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
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.
Screening (-Week 28), Week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206207-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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