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

NCT00460967 | Suspended Phase 3

• 1 other identifier: RHEO-AMD 01-06
• Study Type: interventional
• Target: 325
• Locations: 3 countries
• Sites: 39

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 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.

Conditions

Age-Related Maculopathy

Keywords

non-Exudative (Dry) Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• BCVA (Best Corrected Visual Acuity)

  12 months

Study Arms (2)

1

EXPERIMENTAL

Rheopheresis treatment

Device: Rheopheresis

2

SHAM COMPARATOR

Sham treatment

Device: Rheopheresis

Interventions

Rheopheresis DEVICE

8 rheopheresis treatments over 10 wks.

1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OccuLogix: lead

Study Sites (39)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Associated Retina Consultants, LTD.

Phoenix, Arizona, 85020, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic, Department of Ophthalmology

Scottsdale, Arizona, 85259, United States

Location

Southwest Kidney Institute, PLC, 2149 East Warner Rd. Ste. 109 & 110

Tempe, Arizona, 85284, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

DSI

Brandon, Florida, 33511, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612-7315, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Vitreo-Retinal Associates

Worcester, Massachusetts, 01605, United States

Location

University of Massachuesettes Medical Health Center

Worcester, Massachusetts, 01655, United States

Location

Retinovitreous Associates, Ltd.

Cherry Hill, New Jersey, 08002, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

New York Blood Center

New York, New York, 10021-6275, United States

Location

Macula Care

New York, New York, 10021, United States

Location

Vitreous Retina Macula Consultants

New York, New York, 10022, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Retina Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

Cleveland Clinic Foundation, Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Retina Associates of Cleveland

Lakewood, Ohio, 44107, United States

Location

University of Pennsylvannia Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9073, United States

Location

Memorial Hermann University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital System

Houston, Texas, 77030, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Fairfax Pathology Associates, Ltd.

Annadale, Virginia, 22003, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

Capital Health Systems, Ophthalmology & Visual Sciences

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Victoria General Hospital

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

eyeMD Institute

Brampton, Ontario, L6V 1C2, Canada

Location

Dr. Sapir

Oakville, Ontario, L6J 3P1, Canada

Location

Rheopheresis Center Cologne

Cologne, D-50674, Germany

Location

University of Cologne

Cologne, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Nozhat Choudry, PhD

  OccuLogix, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: January 1, 2007
• Study Completion: December 1, 2009
• Last Updated: November 7, 2007

Record last verified: 2007-04

Locations

US (33); DE (2); CA (4)