Macular DegenerationPhase 3NCT00078221
Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
A Phase 3 study testing Rheopheresis blood filtration in people with Macular Degeneration, run by OccuLogix at 8 sites in 2 countries.
Trial summary
AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Rheopheresis blood filtration
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 1999to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Age 50-85
- Diagnosis of Dry AMD
- BCVA between 20/32 and 20/125 in at least one eye
- Numerous large plaques (soft drusen)
- No history of HIV, Hepatitis B or C
- Elevation of certain blood factors, such as total cholesterol, fibrinogen, and IgA
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Associated Retinal Consultants
Bala-Cynwyd, Pennsylvania, 19004
Retina Vitreous Associates
Beverly Hills, California, 90211
UIC Eye Center
Chicago, Illinois, 60612
Aran Eye Associates
Coral Gables, Florida, 33134
Retina Health Care
Fort Myers, Florida, 33901
Macula Care
New York, New York, 10021
Carolina Eye Associates
Southern Pines, North Carolina, 28387
About this study
AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.
- Conditions
- Macular Degeneration
- Being tested
- Rheopheresis blood filtration
- Keywords
- Dry AMD, Age-related Macular Degeneration, Rheopheresis
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis blood filtrationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2004 (estimated)
- Study startAug 1999
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- OccuLogix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Irving Siegel, MD, Study director, OccuLogix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078221
- Sponsor's protocol ID
- AMD-02-99
- Status last verified
- Dec 2005
- First submitted
- 20 Feb 2004
- Last updated
- 9 May 2008
- Results posted
- No
Publications
Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7.
PubMed 12545682
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheopheresis Blood Filtration Study for the Treatment of Dry Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00078221
- Acronym / sponsor ID
- AMD-02-99
- Conditions
- Macular Degeneration
- Keywords
- Dry AMD, Age-related Macular Degeneration, Rheopheresis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants
- Lead sponsor
- OccuLogixIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- Study completion
- Dec 2005
- First posted
- 1 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AMD is a progressive disease of the retina which is nourished by a network of tiny blood vessels. There is evidence to suggest that the flow of nutrients to the retina is impaired in patients with AMD. Rheopheresis blood filtration uses blood filters that deplete excesses of large proteins, fats and other substances from the blood, improving blood flow to the macula, potentially improving vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheopheresis blood filtration | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
- Background: PubMed 12545682Pulido JS; Multicenter Investigation of Rheopheresis for AMD (MIRA-1) Study Group. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis. Trans Am Ophthalmol Soc. 2002;100:85-106; discussion 106-7.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irving Siegel, MD study director
OccuLogix
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rheopheresis blood filtration in people with Macular Degeneration, run by OccuLogix at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.