Safety and Effectiveness Investigation for Dry, Non-Exudative Age Related Macular Degeneration (AMD) Using Rheopheresis (RHEO-AMD)

Safety and Effectiveness, in a Multi-Center, Randomized, Sham Controlled Investigation for Dry, Non-Exudative Age Related Macular Degeneration (AMD)Using Rheopheresis

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 clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment primarily of central visual acuity. The degenerative retinal eye disease occurs in two forms - a non-exudative "dry" form and an exudative "wet" form which in an individual patient may also represent stages of the disease. Non-exudative AMD accounts for 80-90% of AMD cases and it involves a constellation of clinical features that can include drusen, pigment clumping and/or retinal pigment epithelium (RPE) dropout, and geographic atrophy. Because of the overwhelming numbers of "dry" AMD subjects, the cumulative impact of this vision loss is significant.

There is no effective therapy for maintaining or improving vision associated with dry AMD. The only therapy for persons with dry AMD is an oral supplement containing high doses of antioxidants and zinc, which was tested by the National Eye Institute in a large, multi-center, double-masked, sham-controlled clinical trial1. This antioxidant therapy was shown to modestly retard the progression of dry AMD from an intermediate stage to the advanced stages and confirmed the benefit of antioxidant therapy in this disease. There is currently no FDA-approved therapy for the treatment of subjects with dry AMD.

Recently, the MIRA-1 modified per protocol population showed the effectiveness of Rheopheresis which is an application of selective therapeutic apheresis, namely double filtration plasmapheresis (DFPP) using a specifically designed filter for plasma filtration in subjects with non-exudative AMD. At one year the study reported with statistical significance (1) approximately a one line vision improvement in the Rheopheresis group versus no change in the Sham group and (2) 28% of subjects randomized to the active treatment gaining at least one line vision versus only 9% of subjects randomized to the sham treatment.

With a total of 300 subjects with dry AMD and visual acuity of 20/40-20/100 inclusive, the current investigation plans to prove the effectiveness of the Rheopheresis treatment on a larger scale. Each subject will receive a series of 8 treatments (either active treatment or sham treatment in a 2:1 ratio) for a period of approximately 2.5 months. In addition, a post-treatment ophthalmic evaluation will be performed 2 weeks after the 8th treatment (approximately 3 months after the baseline visit) and at the 6, 9 and 12 month visits. Comparing the one-year proportions of at least a 10-letter gain in ETDRS LogMar BCVA from baseline, the current investigation will show the effectiveness of Rheopheresis treatment (compared to sham treatment) for treating dry AMD subjects. Other secondary effectiveness endpoints, including mean changes and proportions of BCVA better than 20/40 at one year, will be analyzed to support the main investigation.

Study Overview

• Status: Suspended
• Conditions: Age-Related Maculopathy
• Intervention / Treatment: Device: Rheopheresis; Device: Rheopheresis

• Study Type: Interventional
• Enrollment (Anticipated): 325
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Victoria General Hospital
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Capital Health Systems, Ophthalmology & Visual Sciences
  • Ontario
    • Brampton, Ontario, Canada, L6V 1C2
      • eyeMD Institute
    • Oakville, Ontario, Canada, L6J 3P1
      • Dr. Sapir
• Germany
  • Cologne, Germany
    • University of Cologne
  • Cologne, Germany, D-50674
    • Rheopheresis Center Cologne
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
    • Phoenix, Arizona, United States, 85014
      • Retinal Consultants of Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants, Ltd.
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic, Department of Ophthalmology
    • Tempe, Arizona, United States, 85284
      • Southwest Kidney Institute, PLC, 2149 East Warner Rd. Ste. 109 & 110
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • DSI
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60612-7315
      • University of Illinois at Chicago
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Retina Group of Washington
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Vitreo-Retinal Associates
    • Worcester, Massachusetts, United States, 01655
      • University of Massachuesettes Medical Health Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Retinovitreous Associates, Ltd.
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10021
      • Macula Care
    • New York, New York, United States, 10021-6275
      • New York Blood Center
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Retina Associates of Cleveland
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation, Cole Eye Institute
    • Lakewood, Ohio, United States, 44107
      • Retina Associates of Cleveland
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvannia Medical Center
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Dallas, Texas, United States, 75390-9073
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Vitreoretinal Consultants
    • Houston, Texas, United States, 77030
      • The Methodist Hospital System
    • Houston, Texas, United States, 77030
      • Memorial Hermann University of Texas Health Science Center
  • Virginia
    • Annadale, Virginia, United States, 22003
      • Fairfax Pathology Associates, Ltd.
    • Fairfax, Virginia, United States, 22031
      • Retina Group of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Rheopheresis treatment	Device: Rheopheresis; 8 rheopheresis treatments over 10 wks.; Device: Rheopheresis; Sham treatment
Sham Comparator: 2; Sham treatment	Device: Rheopheresis; 8 rheopheresis treatments over 10 wks.; Device: Rheopheresis; Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BCVA (Best Corrected Visual Acuity)	12 months

Collaborators and Investigators

• Sponsor: OccuLogix
• Investigators: Study Director: Nozhat Choudry, PhD, OccuLogix, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: April 16, 2007
• First Submitted That Met QC Criteria: April 16, 2007
• First Posted (Estimate): April 17, 2007

Study Record Updates

• Last Update Posted (Estimate): November 7, 2007
• Last Update Submitted That Met QC Criteria: November 6, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: non-Exudative (Dry) Age-Related Macular Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: RHEO-AMD 01-06