Macular DegenerationNCT00380172
Long-Term Efficacy in AMD of Rheopheresis in North America
A study testing Rheopheresis blood filtration in people with Macular Degeneration, run by OccuLogix at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Rheopheresis blood filtration
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Oct 2005to Oct 2007
- Phase
- Interventional
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 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
The Macula Center
Palm Harbor, Florida, 34684
Carolina Eye Associates
Southern Pines, North Carolina, 28387
About this study
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)
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.
- Conditions
- Macular Degeneration
- Being tested
- Rheopheresis blood filtration
- Keywords
- AMD, Macular Degeneration, Retinal Degeneration
- Medical subject headings
- Macular Degeneration, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis blood filtrationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startOct 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- OccuLogix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nozhat Choudry', Ph.D., Study director, OccuLogix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380172
- Sponsor's protocol ID
- AMD-03-02
- Status last verified
- Sep 2006
- First submitted
- 21 Sep 2006
- Last updated
- 25 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00380172
- Acronym / sponsor ID
- AMD-03-02
- Conditions
- Macular Degeneration
- Keywords
- AMD, Macular Degeneration, Retinal Degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- OccuLogixIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Oct 2007
- First posted
- 25 Sep 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2006.
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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.
Nozhat Choudry', Ph.D. study director
OccuLogix, Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheopheresis blood filtration in people with Macular Degeneration, run by OccuLogix at 9 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?
The sponsor lists 8 inclusion and 14 exclusion criteria. 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 25 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
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.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2006.