---
title: Long-Term Efficacy in AMD of Rheopheresis in North America
nct_id: NCT00380172
overall_status: UNKNOWN
phase: NA
sponsor: OccuLogix
study_type: INTERVENTIONAL
primary_condition: Macular Degeneration
countries: United States, Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00380172.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00380172"
ct_last_update_post_date: 2006-09-25
last_seen_at: "2026-05-12T07:12:46.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT00380172](https://clinicaltrials.gov/study/NCT00380172)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** OccuLogix
- **Conditions:** Macular Degeneration
- **Start Date:** 2005-10
- **Completion Date:** 2007-10
- **CT.gov Last Update:** 2006-09-25

## 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

- **Minimum age:** 0 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Interventions

- **Rheopheresis blood filtration** (DEVICE)

## Primary Outcomes

- **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

- **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.**

## Locations (9)

- Retina Vitreous Associates, Beverly Hills, California, United States
- Aran Eye Associates, Coral Gables, Florida, United States
- Retina Health Care, Fort Myers, Florida, United States
- The Macula Center, Palm Harbor, Florida, United States
- UIC Eye Center, Chicago, Illinois, United States
- Macula Care, New York, New York, United States
- Carolina Eye Associates, Southern Pines, North Carolina, United States
- Associated Retinal Consultants, Bala-Cynwyd, Pennsylvania, United States
- W. Bradley Kates, MD, Oakville, Ontario, Canada

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.retina vitreous associates|beverly hills|california|united states` — added _(2026-05-12)_
- `locations.aran eye associates|coral gables|florida|united states` — added _(2026-05-12)_
- `locations.retina health care|fort myers|florida|united states` — added _(2026-05-12)_
- `locations.the macula center|palm harbor|florida|united states` — added _(2026-05-12)_
- `locations.uic eye center|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.macula care|new york|new york|united states` — added _(2026-05-12)_
- `locations.carolina eye associates|southern pines|north carolina|united states` — added _(2026-05-12)_
- `locations.associated retinal consultants|bala-cynwyd|pennsylvania|united states` — added _(2026-05-12)_
- `locations.w. bradley kates, md|oakville|ontario|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00380172.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00380172*  
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