Dry Age-related Macular DegenerationPAMNCT00926861
Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD
An observational study of Dry Age-related Macular Degeneration and Detachment of the Posterior Hyaloid, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration, Detachment of the Posterior Hyaloid
- What is being tested?
- ultrasound and OCT
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Dec 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male or female persons aged over 50 years with dry AMD
Who may be able to join
- Dry MD
- Age over 50 years
Who cannot join
- Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
- Prior vitrectomy or buckle surgery
- Uveitis posterior, multifocal chorioiditis
- Pathologic myopia
- Diabetic retinopathy
- Visualization of the macula not possible (dens cataract, vitreous haemorrhage)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Vienna, State of Vienna, 1030
Ilse Krebs, MD, 43-17-1165 ext. 94682, Ilse.Krebs@wienkav.at
Ilse Krebs, MD
About this study
Official title: Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.
- Being tested
- ultrasound, OCT
- Keywords
- age-related macular degeneration, detachment of the posterior hyaloid, AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
A-scan and B-scan ultrasound at baseline and month 6,12,24
OCTDevice
Volume scans of spectralis OCT at baseline and month 6,12,24
| Study group | Role | What they receive |
|---|---|---|
| Dry AMD | male or female persons aged over 50 years with dry age-related macular degeneration Receives: Device: ultrasound; Device: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD
Measured: 24 months
Secondary outcomes (5)
Distance acuity
Measured: 24 months
Age
Measured: 24 months
Smoking
Measured: 24 months
Obesity
Measured: 24 months
Lesion classification (AREDS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, Prof MD, Study chair, Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926861
- Sponsor's protocol ID
- 09-052-0409
- Acronym
- PAM
- Status last verified
- Jun 2010
- First submitted
- 23 Jun 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD
- ClinicalTrials.gov ID
- NCT00926861
- Acronym / sponsor ID
- PAM / 09-052-0409
- Keywords
- age-related macular degeneration, detachment of the posterior hyaloid, AMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Jun 2009 (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.
Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry AMD | – | Device: ultrasound, Device: OCTmale or female persons aged over 50 years with dry age-related macular degeneration |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male or female persons aged over 50 years with dry AMD
Key inclusion criteria (2 listed)
- Dry MD
- Age over 50 years
Key exclusion criteria (6 listed)
- Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
- Prior vitrectomy or buckle surgery
- Uveitis posterior, multifocal chorioiditis
- Pathologic myopia
- Diabetic retinopathy
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 |
|---|---|---|
| ultrasoundA-scan and B-scan ultrasound at baseline and month 6,12,24 | Device | Dry AMD |
| OCTVolume scans of spectralis OCT at baseline and month 6,12,24 | Device | Dry AMD |
Primary outcome
Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD
Time frame: 24 months
5 secondary outcomes
Distance acuity
Time frame: 24 months
Age
Time frame: 24 months
Smoking
Time frame: 24 months
Obesity
Time frame: 24 months
Lesion classification (AREDS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
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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.
Susanne Binder, Prof MD study chair
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Age-related Macular Degeneration and Detachment of the Posterior Hyaloid, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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 2 inclusion and 6 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 9 Jun 2010. 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 Austria. 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?
Contact Ilse Krebs, MD (+43171165 ext. 4607, ilse.krebs@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD (time frame: 24 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 9 Jun 2010.