Status:
SUSPENDED
Safety and Effectiveness Investigation for Dry, Non-Exudative Age Related Macular Degeneration (AMD) Using Rheopheresis
Lead Sponsor:
OccuLogix
Conditions:
Age-Related Maculopathy
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
SUMMARY Age-related macular degeneration (AMD) is the leading cause of late onset visual impairment and legal blindness in people 65 years of age or older in the United States. It is a heterogeneous ...
Eligibility Criteria
Inclusion
- Study eye must have a diagnosis of non-exudative, "Dry", AMD with equivalent drusen surface area of approximately 31,000 µm2 \[e.g. at least 10 soft, semi-soft intermediate size ≥63µm or at least 3 drusen size ≥125 µm within 3,000 µm of the fovea documented on macular exam, retinal angiography and fundus photographs as determined by the reading center. ETDRS BCVA of 20/40 - 20/100 inclusive
Exclusion
- Either eye with previous or active sub-retinal neovascularization (SRNV) or choroidal neovascularization (CNV)
- Pigment epithelial detachment (PED) within 500 µm of the fovea
- Either eye with a diagnosis of exudative (wet) AMD
- Subjects having undergone cataract surgery less than 3 months prior to enrollment without an open posterior capsule
- Uncontrolled hypertension and/or diabetes
- Subjects with prolonged PT/PTT (unless the subject is taking warfarin), hematocrit \<35%, evidence of active bleeding, platelet count \<100,000/ml
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00460967
Start Date
January 1 2007
End Date
December 1 2009
Last Update
November 7 2007
Active Locations (39)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
Associated Retina Consultants, LTD.
Phoenix, Arizona, United States, 85020
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
4
Mayo Clinic, Department of Ophthalmology
Scottsdale, Arizona, United States, 85259