Long-Term Efficacy in AMD of Rheopheresis in North America

Study Overview
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Brief Summary
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The purpose of these studies are to evaluate the effect on vision in subjects with AMD who received active and placebo treatment in the MIRA-1 study.

Official Title
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A Multicenter, Open Label, Prospective Study to Determine Safety and Efficacy Over an Additional 12-Month Period With Non-Exudative Age-Related Macular Degeneration (With Follow-on to 12-Months)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Device: Rheopheresis blood filtration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have participated in treatment arm of MIRA-1 trial and completed 4 treatments and 6 and 9 month follow up visits. Dry AMD in at least one eye. Available for study duration of 12 months. Weigh >110 lbs. If on lipid-lowering medication must remain on for duration of trial. If not, must agree to not initate during trial. Normal Pt/ PTT. If on coumadin, at the discretion of the investigator. Must be highly motivated, alert and oriented, and able to provide consent. Agree to discontinue current ocular vitamin regimen and take uniform supplement provided by the sponsor. Exclusion Criteria: Both eyes wet AMD. Condition limiting view of the fundus. Poor general health or unstable diseases. HCT < 35%, evidence of active bleeding, platelet count <100000 K/uL, prolonged Pt/ PTT, or significant coagupapathies. significant cardiac problems. Uncontrolled hypertension. History of CVA of TIA within a year. Significant hepatic, renal, or pulmonary disease, or insulin dependent diabetes. Allergy to fluorescein sodium and indocyanine green (ICG), heparin, ACDA, local anesthetics, or adhesive tape. Pregnant or breastfeeding women, or women of childbearing potential not using chemical or mechanical contraception. Investigation trial within 30 days. Major surgery within 30 days. Unwilling to adhere to visit schedule. Unstable medical of psychological condition.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Rheopheresis blood filtration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the change from baseline and ETDRS visual acuity in subjects with non-exudative AMD who participated in AMD-02-99. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is to evaluate the safety of rheopheresis filtration treatments in subjects with non-exudative AMD as measured by AE's early DC's and Lab evaluations. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Macular Degeneration, Retinal Degeneration