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Sponsored by: |
St. Erik Eye Hospital |
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Information provided by: | St. Erik Eye Hospital |
ClinicalTrials.gov Identifier: | NCT00599222 |
Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.
Condition | Intervention | Phase |
---|---|---|
Neovascular Age-Related Macular Degeneration |
Biological: ranibizumab Procedure: TTT Procedure: Sham TTT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-Related Macular Degeneration (AMD) |
Estimated Enrollment: | 100 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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TTT: Active Comparator
TTT is given every three months
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Biological: ranibizumab
0.5 mg intravitreal injection
Procedure: TTT
Transpupillary thermotherapy (TTT)
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Sham TTT: Sham Comparator
Sham TTT is given every three months
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Biological: ranibizumab
0.5 mg intravitreal injection
Procedure: Sham TTT
Sham Transpupillary thermotherapy (TTT)
|
Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | St Eriks Eye Hospital ( Stefan Seregard ) |
Study ID Numbers: | LUTA001 |
Study First Received: | January 10, 2008 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00599222 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
AMD macular degeneration anti-VEGF laser treatment |
Eye Diseases Retinal Degeneration Macular Degeneration Bevacizumab Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |