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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00813891
First received: December 22, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Visual Acuity
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Ranibizumab (Lucentis) in Combination With Photodynamic Therapy for Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 after PDT with verteporfin
Other Name: 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 with no accompanying PDT with verteporfin
Other Name: Lucentis the brand name of Ranibizumab

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813891

Contacts
Contact: John Galic, MD 514-285-8866
Contact: Karin Oliver, MD 514-285-8866 karin.oliver@hotmail.com

Locations
Canada, Quebec
The Royal Victoria Hospital and the Montreal Retinal Institute Not yet recruiting
Montreal, Quebec, Canada, H3Z 1P4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: John Galic, MD Montreal Retina Institute
Principal Investigator: John Chen, MD Montreal Retina Institute
  More Information

Additional Information:
Publications:

Responsible Party: McGill University Health Center, McGill Ophthalmology
ClinicalTrials.gov Identifier: NCT00813891     History of Changes
Other Study ID Numbers: MUHC - 1234 - RVH
Study First Received: December 22, 2008
Last Updated: December 22, 2008
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
ranibizumab
verteporfin

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Verteporfin
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014