Second Line Therapy to Treat Age-related Macular Degeneration (AMD) for Patients Not Responding Well to Lucentis Therapy by Itself

August 21, 2017 updated by: Vitreous -Retina- Macula Consultants of New York

A Multicenter, Randomized, Single-Masked Comparison of Lucentis™ Monotherapy With Triple Therapy of Reduced Fluence Visudyne-Lucentis-Dexamethasone (V-L-D) in Patients With CNV Secondary to AMD as Second Line Therapy After Lucentis Monotherapy

The purpose of this study is to demonstrate that Visudyne-Lucentis-dexamethasone (V-L-D) triple therapy will give similar efficacy and safety results as Lucentis monotherapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study Design:

Patients who have received 2-6 previous treatments with Lucentis monotherapy and who have exudative activity associated with the choroidal neovascularization (CNV) lesion, as confirmed by fluorescein angiography (FA) or optical coherence tomography (OCT), will be eligible. Patients will be randomly assigned at 4-8 weeks after the previous Lucentis treatment to either

  1. continuation of Lucentis monotherapy
  2. triple therapy with half fluence Visudyne (300 mW/cm2 for 83 seconds) followed within 2 hours by intravitreal Lucentis 0.5 mg (first injection) and then dexamethasone 0.5 mg (second injection) (V-L-D).

Both groups will receive treatment at baseline and then as needed (PRN), according to retreatment criteria, with monthly assessments thereafter for 12 months. In the triple therapy group, patients may only be retreated with the V-L-D combination at intervals of no less than 3 months; if retreatment is needed 1 or 2 months after a previous V-L-D treatment, the patient will receive a Lucentis injection at that visit; however, if retreatment is needed and the previous V-L-D treatment was at least 3 months prior, then V-L-D treatment is mandatory. OCT, visual acuity (VA) testing, and possibly FA will be conducted at each assessment visit to define the need for retreatment.

Study Type

Interventional

Phase

  • Phase 2

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

N/A

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Patients with subfoveal CNV due to AMD who, after 2-6 previous treatments with Lucentis monotherapy, continue to have exudative activity associated with the CNV lesion 4-8 weeks after the last treatment. Exudative activity is defined as one or more of:

    • CNV leakage confirmed by FA
    • New hemorrhage associated with the CNV lesion
    • Subretinal fluid or cystoid macular edema by OCT showing retinal thickness ≥ 230 μm
  • All lesion composition types with a lesion greatest linear dimension (GLD) ≤ 5400 microns (approximately ≤ 9 disc areas [DA])
  • Best corrected ETDRS VA score of 25-73 letters (approximate Snellen equivalent of 20/40-20/320)

Main Exclusion Criteria:

  • Subfoveal geographic atrophy or subfoveal fibrosis in the study eye
  • Intraocular surgery within 3 months of enrollment
  • Inability to attend the protocol-required visits
  • Known allergies or hypersensitivity to any of the study treatments

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: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

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

Sponsor

Vitreous -Retina- Macula Consultants of New York

Collaborators

QLT Inc.

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 (Anticipated)

January 1, 2007

Primary Completion (Actual)

December 4, 2007

Study Completion (Actual)

December 4, 2007

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (Estimate)

April 6, 2007

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPER

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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