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Retaane® in Age-Related Macular Degeneration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569569
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rudolf Foundation Clinic
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Retaane® in Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Rudolf Foundation Clinic:

Primary Outcome Measures:
  • Increase in VA [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Decrease in Macula Edema [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569569


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

ClinicalTrials.gov Identifier: NCT00569569     History of Changes
Other Study ID Numbers: RFC012007
First Submitted: December 5, 2007
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
Last Verified: December 2007

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