Age-Related Macular DegenerationNCT00347906
Photodynamic Therapy (PDT) Versus Transpupillary Thermotherapy (TTT) in Occult Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (AMD)
A study testing laser treatment in people with Age-Related Macular Degeneration, run by University Hospital, Linkoeping.
Trial summary
The purpose of this study is to compare the effect of PDT and TTT for the treatment of subfoveal occult CNV in age-related macular degeneration. 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
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 2003to Sep 2005
- 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,
- Subfoveal occult only CNV due to AMD,
- < 4 disc areas or > 4 disc areas
- VA < 0.4
Who cannot join
- Sign of classic CNV,
- CNV in other diagnoses than AMD,
About this study
Official title: Photodynamic Therapy Versus Transpupillary Thermotherapy in Occult CNV in Age-related Macular Degeneration
The purpose of this study is to compare the effect of PDT and TTT for the treatment of subfoveal occult CNV in age-related macular degeneration.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- laser treatment
- 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
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 startNov 2003
- Study completionSep 2005
Why it stopped: Difficulties in recruiting patients
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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
- NCT00347906
- Sponsor's protocol ID
- Dnr 00052
- Status last verified
- Nov 2003
- First submitted
- 3 Jul 2006
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy Versus Transpupillary Thermotherapy in Occult CNV in Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00347906
- Acronym / sponsor ID
- Dnr 00052
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patients
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Sep 2005
- 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.
The purpose of this study is to compare the effect of PDT and TTT for the treatment of subfoveal occult CNV in age-related macular degeneration.
Study design
- 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 (4 listed)
- > 55 years of age,
- Subfoveal occult only CNV due to AMD,
- < 4 disc areas or > 4 disc areas
- VA < 0.4
Key exclusion criteria (2 listed)
- Sign of classic CNV,
- CNV in other diagnoses than AMD,
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Christina I Frennesson, MD, PhD principal investigator
Linkoeping University
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.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Difficulties in recruiting patients). 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?
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 12 Jan 2010.