Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

May 6, 2008 updated by: Barnes Retina Institute

An Open-Label, Single-Site, Comparative, Pilot Study of the Treatment Effects of Combination Therapy of Lucentis (Ranibizumab) Plus Reduced Fluence Photodynamic Therapy With Visudyne in Patients With Exudative Age-Related Macular Degeneration (AMD)

The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes Retina Institute
        • Principal Investigator:
          • Gaurav K Shah, MD

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:

  • Ability to give informed consent
  • Treatment- naïve patients with active, subfoveal, exudative AMD
  • Patients with visual acuity of 20/40-20/320 in the study eye
  • Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
  • The lesion must be < 5400microns in greatest linear dimension (GLD)
  • Lesion size < 10 DA

  • Occult with no classic CNV lesions must have presumed recent disease progression:

    1. Blood associated with the lesion at baseline
    2. Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
    3. > 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
  • Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye
  • Geographic atrophy or fibrosis in the study eye
  • Intraocular surgery within 6 weeks of enrollment
  • Subretinal hemorrhage > 50% of the total lesion
  • Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
  • Patients with severe disciform scarring.
  • Inability to make study visits
  • Advanced glaucoma
  • Allergies to porfins or a known hypersensitivity to any component of Visudyne®
  • Patients with porphyria
  • Pregnancy or lactation

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lucentis plus Reduced Fluence PDT same day
Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection
Active Comparator: Lucentis plus reduced fluence PDT 1-2 weeks later
Drug: reduced fluence photodynamic therapy with Visudyne
reduced fluence photodynamic therapy with visudyne
Drug: Lucentis
Lucentis intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of the combination therapy
Time Frame: 12 months and 24 months
12 months and 24 months
To assess efficacy of the two timing regimens
Time Frame: 12 months and 24 months
12 months and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the number of Lucentis injections and the number of PDT treatments required during the study
Time Frame: 12 months and 24 months
12 months and 24 months

Collaborators and Investigators

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

Sponsor

Barnes Retina Institute

Collaborators

QLT Inc.

Investigators

  • Principal Investigator: Gaurav K. Shah, MD, Barnes Retina Institute

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

April 1, 2007

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0769
  • NCT00455871

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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