Age-related Macular DegenerationNCT00348543
Prophylactic Laser Treatment of Drusen Maculopathy
A study testing laser treatment in people with Age-related Macular Degeneration, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- laser treatment
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Dec 1999to Oct 2006
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 55 years of age,
- Soft drusen maculopathy,
- VA 0.8-1.0
Who cannot join
- VA <0.8,
- Pigment clumps,
- PED,
- CNV,
- Atrophy,
- Haemorrhage,
Show all 9Show fewer
- Diabetes retinopathy,
- Sign cataract,
- Glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.
To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.
- Conditions
- Age-related Macular Degeneration
- Being tested
- laser treatment
- Keywords
- age-related macula degeneration, prophylactic laser treatment, exudative complication
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Secondary outcomes (1)
incidence of exudative complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startDec 1999
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Investigators
- Christina I Frennesson, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348543
- Sponsor's protocol ID
- Dnr 97346
- Status last verified
- Oct 1999
- First submitted
- 3 Jul 2006
- Last updated
- 5 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Laser Treatment of Drusen Maculopathy in Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT00348543
- Acronym / sponsor ID
- Dnr 97346
- Conditions
- Age-related Macular Degeneration
- Keywords
- age-related macula degeneration, prophylactic laser treatment, exudative complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Dec 1999
- Study completion
- Oct 2006 (actual)
- First posted
- 4 Jul 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.
To study the effect of mild laser treatment on the incidence of exudative complications in soft drusen maculopathy. We hypothesise that mild laser treatment causing a proliferation of the retinal pigment epithelium and enhancing the capacity of clearing drusen material from Bruch's membrane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 55 years of age,
- Soft drusen maculopathy,
- VA 0.8-1.0
Key exclusion criteria (9 listed)
- VA <0.8,
- Pigment clumps,
- PED,
- CNV,
- Atrophy,
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 |
|---|---|---|
| laser treatment | Procedure or surgery | – |
Primary outcome
Change in visual acuity
1 secondary outcome
incidence of exudative complications
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 5 Aug 2011.
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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.
Christina I Frennesson, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser treatment in people with Age-related Macular Degeneration, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 9 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 5 Aug 2011. 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 Sweden. 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?
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?
Change in visual acuity. 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 5 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.