NCT00380172

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
2 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 25, 2006

Status Verified

September 1, 2006

First QC Date

September 21, 2006

Last Update Submit

September 21, 2006

Conditions

Macular Degeneration

Keywords

AMDMacular DegenerationRetinal Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

Rheopheresis blood filtrationDEVICE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Aran Eye Associates

Coral Gables, Florida, 33134, United States

Location

Retina Health Care

Fort Myers, Florida, 33901, United States

Location

The Macula Center

Palm Harbor, Florida, 34684, United States

Location

UIC Eye Center

Chicago, Illinois, 60612, United States

Location

Macula Care

New York, New York, 10021, United States

Location

Carolina Eye Associates

Southern Pines, North Carolina, 28387, United States

Location

Associated Retinal Consultants

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

W. Bradley Kates, MD

Oakville, Ontario, L6H 3P1, Canada

Location

MeSH Terms

Conditions

Macular DegenerationRetinal Degeneration

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesEye Diseases, Hereditary

Study Officials

  • Nozhat Choudry', Ph.D.

    OccuLogix, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2007

Last Updated

September 25, 2006

Record last verified: 2006-09

Locations

US(8)CA(1)