Long-Term Efficacy in AMD of Rheopheresis in North America

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OccuLogix

Status

Unknown

Conditions

Macular Degeneration

Treatments

Device: Rheopheresis blood filtration

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380172
AMD-03-02

Details and patient eligibility

About

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.

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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