Dry Age Related Macular DegenerationPhase 4ARTNCT00751361
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
A Phase 4 study testing Rheopheresis / double filtration plasmapheresis in people with Dry Age Related Macular Degeneration, run by Apheresis Research Institute at 1 site in Germany.
Trial summary
Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dry Age Related Macular Degeneration
- What is being tested?
- Rheopheresis / double filtration plasmapheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Nov 1998to Jan 2003
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 to 85 years old
- diagnosis of AMD in both eyes
- must have dry AMD in the study eye
- Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
- peripheral veins allowing vascular access to establish the extracorporal circuit.
Who cannot join
- other retinal or choroidal disorders than AMD
- optic nerve disease, glaucoma
- conditions that limit the view of the fundus
- acute bleeding in any eye
- General exclusion criteria for the treatment of Rheopheresis:
- anaemia
Show all 14Show fewer
- haemorrhagic diathesis or coagulopathy
- diabetes
- serious acute or chronic kidney or liver failure
- hypotension systolic < 100 mmHg
- chronic viral infection (HIV, hepatitis B, C)
- epilepsia, psychosis or dementia
- a malignant disease or any other condition with life expectancy < 12 months
- known history of alcohol or drug abuse and long term serious nicotine abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Frankfurt Department of Ophthalmology
Frankfurt, 60590
About this study
Official title: Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART
Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.
- Conditions
- Dry Age Related Macular Degeneration
- Being tested
- Rheopheresis / double filtration plasmapheresis
- Keywords
- Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheopheresis / double filtration plasmapheresisDevice
Also called Rheopheresis, Double filtration plasmapheresis
Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks Receives: Device: Rheopheresis / double filtration plasmapheresis |
| 2 | No intervention | No treatment control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.
Measured: 30 weeks (7.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startNov 1998
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age Related 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apheresis Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Frank HJ Koch, Prof. Dr., Principal investigator, University of Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751361
- Sponsor's protocol ID
- AR-2000
- Acronym
- ART
- Status last verified
- Sep 2008
- First submitted
- 10 Sep 2008
- Last updated
- 11 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART
- ClinicalTrials.gov ID
- NCT00751361
- Acronym / sponsor ID
- ART / AR-2000
- Conditions
- Dry Age Related Macular Degeneration
- Keywords
- Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Apheresis Research InstituteUniversity, hospital or other
- Study start
- Nov 1998
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 11 Sep 2008 (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.
Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Rheopheresis / double filtration plasmapheresisTreatment group: Patients receive 10 Rheopheresis treatments within 17 weeks |
| 2 | No intervention | –No treatment control group |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 to 85 years old
- diagnosis of AMD in both eyes
- must have dry AMD in the study eye
- Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
- peripheral veins allowing vascular access to establish the extracorporal circuit.
Key exclusion criteria (14 listed)
- other retinal or choroidal disorders than AMD
- optic nerve disease, glaucoma
- conditions that limit the view of the fundus
- acute bleeding in any eye
- anaemia
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 / double filtration plasmapheresisAlso: Rheopheresis, Double filtration plasmapheresisRheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis. | Device | 1 |
Primary outcome
The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.
Time frame: 30 weeks (7.5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2008.
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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.
Frank HJ Koch, Prof. Dr. principal investigator
University of Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rheopheresis / double filtration plasmapheresis in people with Dry Age Related Macular Degeneration, run by Apheresis Research Institute at 1 site in Germany.
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 5 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: finished, as of the sponsor's last update on 11 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. (time frame: 30 weeks (7.5 months)). 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 11 Sep 2008.