Condition category
Eye Diseases
Date applied
11/04/2007
Date assigned
22/06/2007
Last edited
22/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.essen.de/

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

Publication citations

Additional files

Editorial Notes