Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration

December 22, 2008 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

Efficacy of Ranibizumab (Lucentis) in Combination With Photodynamic Therapy for Neovascular Age-Related Macular Degeneration

The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.

Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.

Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular AMD.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

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

  • Name: John Galic, MD
  • Phone Number: 514-285-8866

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3Z 1P4
        • The Royal Victoria Hospital and the Montreal Retinal Institute

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:

  • diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
  • must be 50 years of age or older
  • have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye
  • CNV that is more than 50% obscured by blood
  • have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
  • have been assessed with the use of early treatment diabetic retinopathy study charts

Exclusion Criteria:

  • previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
  • any permanent structural damage to the central fovea

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pre-PDT
Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Active Comparator: Post-PDT
Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Active Comparator: No PDT
Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
Other Names:
  • Lucentis the brand name of Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.
Time Frame: Monthly for a total of 12 months
Monthly for a total of 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the following: 1:Proportion of subjects who loose fewer than 15 letters from baseline visual acuity at 6 months 2: Proportion of subjects with VA of 20/200 or worse 3: Proportion of subjects with VA of 20/40 or better
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: John Galic, MD, Montreal Retina Institute
  • Principal Investigator: John Chen, MD, Montreal Retina Institute

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

January 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (Estimate)

December 23, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2008

Last Update Submitted That Met QC Criteria

December 22, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHC - 1234 - RVH

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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