Retaane® in Age-Related Macular Degeneration

• Sponsor: Rudolf Foundation Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00569569
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 12.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: juxtascleral depot injection of Retaane	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Retaane® in Age-Related Macular Degeneration
• Study Start Date: Feb 1, 2006
• Actual Study Completion Date: Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Patients treated with Retaane	Drug: juxtascleral depot injection of Retaane; juxtascleral depot injection of Retaane

Outcome Measures

Primary Outcome Measures

1. Increase in VA [6 months]

Secondary Outcome Measures

1. Decrease in Macula Edema [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rudolf Foundation Clinic

Investigators

• Study Chair: Susanne Binder, M.D., no affiliation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00569569
• Other Study ID Numbers: RFC012007
• First Posted: Dec 7, 2007
• Last Update Posted: Dec 7, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Dec 7, 2007