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NCT00569569 Clinical Trial

Retaane® in Age-Related Macular Degeneration

Age Related Macular Degeneration Clinical Trial

Official title:
Retaane® in Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00569569
Other study ID # RFC012007
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 5, 2007
Last updated December 6, 2007
Start date February 2006
Est. completion date March 2007

Study information
Verified date December 2007
Source Rudolf Foundation Clinic
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• juxtascleral depot injection of Retaane
juxtascleral depot injection of Retaane

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rudolf Foundation Clinic

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in VA 6 months No
Secondary Decrease in Macula Edema 6 months No
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