Contact information
Type
Scientific
Primary contact
Dr Andreas Lipski
ORCID ID
Contact details
University Eye Clinic of Essen
Hufelandstr. 55
Essen
45138
Germany
andreas.lipski@uni-duisburg-essen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PDT/001
Study information
Scientific title
Acronym
PDT in young CNV
Study hypothesis
To test efficacy and safety of Photodynamic Therapy (PDT) in young patients with Choroidal Neovascularisations (CNV).
Ethics approval
No ethics board approval was sought because this study is a collection of prospective case experiences during the last eight years. By the time the first patients were treated no approval was gained.
Study design
Open-label, uncontrolled, prospective trial.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Choroidal neovascularization in younger patients
Intervention
Photodynamic therapy with verteporfin (Visudyne). An infusion of verteporfin (for 10 minutes) and laser application to the retina in one study eye (83 seconds) was performed. There was no treatment of the second eye with this method.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Visual acuity
2. Lesion size
Mean follow-up of 34.4 months.
Secondary outcome measures
Application number (per year).
Mean follow-up of 34.4 months.
Overall trial start date
01/08/1999
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients below age 30
2. Vision-limiting choroidal neovascularisation
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
15
Participant exclusion criteria
Previous (laser) treatment.
Recruitment start date
01/08/1999
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Germany
Trial participating centre
University Eye Clinic of Essen
Essen
45138
Germany
Sponsor information
Organisation
University Eye Clinic of Essen (Germany)
Sponsor details
Hufelandstr. 55
Essen
D-45138
Germany
andreas.lipski@uni-duisburg-essen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Eye Clinic of Essen (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary