Retaane® in Age-Related Macular Degeneration - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 5, 2007

Last Updated Date

December 6, 2007

Start Date ^†

February 2006

Current Primary Outcome Measures ^†

Increase in VA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00569569 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Decrease in Macula Edema [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Retaane® in Age-Related Macular Degeneration

Official Title ^†

Retaane® in Age-Related Macular Degeneration

Brief Summary

The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options.

While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available. Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^†

Age Related Macular Degeneration

Intervention ^†

Drug: juxtascleral depot injection of Retaane

Study Arms / Comparison Groups

Experimental: Patients treated with Retaane

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

rejection of intravitreal injections
presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration

Exclusion Criteria:

conditions precluding judgement of the fundus

Gender

Both

Ages

20 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00569569

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Rudolf Foundation Clinic

Collaborators ^††

Investigators ^†

Study Chair:

Susanne Binder, M.D.

no affiliation

Information Provided By

Rudolf Foundation Clinic

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.