Clinical trial NCT00380172: Long-Term Efficacy in AMD of Rheopheresis in North America
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Degeneration
Keywords: AMD
Macular Degeneration
Retinal Degeneration
Lead sponsor: OccuLogix
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates
state: California
city: Coral Gables
country: United States
facility: Aran Eye Associates
state: Florida
city: Ft. Myers
country: United States
facility: Retina Health Care
state: Florida
city: Palm Harbor
country: United States
facility: The Macula Center
state: Florida
city: Chicago
country: United States
facility: UIC Eye Center
state: Illinois
city: New York
country: United States
facility: Macula Care
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Bala Cynwyd
country: United States
facility: Associated Retinal Consultants
state: Pennsylvania
city: Oakville,
country: Canada
facility: W. Bradley Kates, MD
state: Ontario
Study officials:
affiliation: OccuLogix, Inc.
name: Nozhat Choudry', Ph.D.
role: STUDY_DIRECTOR
References: