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

Age-Related Maculopathy Clinical Trial

— RHEO-AMD  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00460967
• Other study ID #: RHEO-AMD 01-06
• Status: Suspended
• Phase: Phase 3
• First received: April 16, 2007
• Last updated: November 6, 2007
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2007
• Source: OccuLogix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada :Therapeutics Products Directorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 325
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Maculopathy
• Geographic Atrophy
• Macular Degeneration

Intervention

Device:
• Rheopheresis
8 rheopheresis treatments over 10 wks.
• Rheopheresis
Sham treatment

Locations

Country	Name	City	State
Canada	eyeMD Institute	Brampton	Ontario
Canada	Capital Health Systems, Ophthalmology & Visual Sciences	Halifax	Nova Scotia
Canada	Victoria General Hospital	Halifax	Nova Scotia
Canada	Dr. Sapir	Oakville	Ontario
Germany	Rheopheresis Center Cologne	Cologne
Germany	University of Cologne	Cologne
United States	Fairfax Pathology Associates, Ltd.	Annadale	Virginia
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	DSI	Brandon	Florida
United States	Retinovitreous Associates, Ltd.	Cherry Hill	New Jersey
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation, Cole Eye Institute	Cleveland	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Retina Group of Washington	Fairfax	Virginia
United States	Memorial Hermann University of Texas Health Science Center	Houston	Texas
United States	The Methodist Hospital System	Houston	Texas
United States	Vitreoretinal Consultants	Houston	Texas
United States	Retina Associates of Cleveland	Lakewood	Ohio
United States	Good Samaritan Hospital	Los Angeles	California
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Columbia University	New York	New York
United States	Macula Care	New York	New York
United States	New York Blood Center	New York	New York
United States	Vitreous Retina Macula Consultants	New York	New York
United States	University of Pennsylvannia Medical Center	Philadelphia	Pennsylvania
United States	Associated Retina Consultants, LTD.	Phoenix	Arizona
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Mayo Clinic, Department of Ophthalmology	Scottsdale	Arizona
United States	Southwest Kidney Institute, PLC, 2149 East Warner Rd. Ste. 109 & 110	Tempe	Arizona
United States	Center for Retina and Macular Disease	Winter Haven	Florida
United States	University of Massachuesettes Medical Health Center	Worcester	Massachusetts
United States	Vitreo-Retinal Associates	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
OccuLogix

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA (Best Corrected Visual Acuity)		12 months