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Retaane® in Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Rudolf Foundation Clinic
ClinicalTrials.gov Identifier:
NCT00569569
First received: December 5, 2007
Last updated: December 6, 2007
Last verified: December 2007
History of Changes
  Purpose

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 Intervention Phase
Age Related Macular Degeneration
 Drug: juxtascleral depot injection of Retaane
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retaane® in Age-Related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rudolf Foundation Clinic:

Primary Outcome Measures:
  • Increase in VA [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Enrollment: 20
Study Start Date: February 2006
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: 1
Patients treated with Retaane
 Drug: juxtascleral depot injection of Retaane
juxtascleral depot injection of Retaane

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569569

Sponsors and Collaborators
Rudolf Foundation Clinic
Investigators
Study Chair: Susanne Binder, M.D. no affiliation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00569569     History of Changes
Other Study ID Numbers: RFC012007
Study First Received: December 5, 2007
Last Updated: December 6, 2007
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013