Long-term vision gain after PhotoDynamic Therapy of Choroidal NeoVascularisations in pediatric and young adult patients

ISRCTN	ISRCTN24428087
DOI	https://doi.org/10.1186/ISRCTN24428087
Protocol serial number	PDT/001
Sponsor	University Eye Clinic of Essen (Germany)
Funder	University Eye Clinic of Essen (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andreas Lipski
Scientific

University Eye Clinic of Essen
Hufelandstr. 55
Essen
45138
Germany

Email	andreas.lipski@uni-duisburg-essen.de

Primary study design	Interventional
Study design	Open-label, uncontrolled, prospective trial.
Secondary study design	Non randomised controlled trial
Scientific title	Long-term vision gain after PhotoDynamic Therapy of Choroidal NeoVascularisations in pediatric and young adult patients
Study acronym	PDT in young CNV
Study objectives	To test efficacy and safety of Photodynamic Therapy (PDT) in young patients with Choroidal Neovascularisations (CNV).
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Visual acuity 2. Lesion size Mean follow-up of 34.4 months.
Key secondary outcome measure(s)	Application number (per year). Mean follow-up of 34.4 months.
Completion date	01/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	15
Key inclusion criteria	1. Patients below age 30 2. Vision-limiting choroidal neovascularisation
Key exclusion criteria	Previous (laser) treatment.
Date of first enrolment	01/08/1999
Date of final enrolment	01/07/2006

University Eye Clinic of Essen

Essen
45138
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		20/03/2008	25/10/2021	Yes	No

25/10/2021: Publication reference added.