Status:
COMPLETED
Combination Therapy for Age-Related Macular Degeneration.
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
QLT Inc.
Canadian Retinal Trials Group
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the study is to investigate whether patients with Choroidal Neovascularization secondary to Age-related Macular Degeneration, receiving triple or double therapy compared to mono...
Detailed Description
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in developed countries throughout the world.The beneficial therapeutic effect of Photodynamic Therapy (PDT)in the ...
Eligibility Criteria
Inclusion
- Choroidal neovascularization (CNV) secondary to age-related macular. All lesion subtypes, based upon IVFA evaluation will be included.
- CNV under the geometric centre of the foveal avascular zone.
- Evidence of choroidal neovascular activity as suggested by one of the following: sub-retinal lipid, sub-retinal hemorrhage, and documented loss of 3 lines of vision within the last three months.
- Greatest linear dimension of the lesion \</= 5400 um.
- Visual acuity of between 20/32 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 metres.
- Willingness and ability to participate and provide written informed consent
Exclusion
- Individuals with choroidal neovascularization from causes other than AMD.
- Individuals physically unable to tolerate intravenous fluorescein angiography or Verteporfin injections. (Specifically, individuals with inadequate venous access or an allergy/sensitivity to fluorescein dye/porphyrins will be excluded.)
- Any intraocular surgery within 3 months in the study eye.
- Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling in the study eye.
- Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
- Individuals with physical or mental disabilities that prevent accurate vision testing.
- History of treatment of CNV in study eye other than extrafoveal confluent laser photocoagulation.
- Prior photodynamic therapy for CNV in the study eye.
- Active hepatitis or clinically significant liver disease
- Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
- Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
- Women of child-bearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medications.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00376701
Start Date
September 1 2006
End Date
April 1 2009
Last Update
September 28 2011
Active Locations (5)
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1
The University of Alberta and Capital Health
Edmonton, Alberta, Canada, T5H 3V9
2
The University of British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
3
Dr. Stanley G. Shortt
Victoria, British Columbia, Canada, V8V 4X3
4
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, Canada, N6A 4G5