Back to resultsRetaane® in Age-Related Macular Degeneration
Primary Purpose
Age Related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
juxtascleral depot injection of Retaane
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patients treated with Retaane
Outcomes
Primary Outcome Measures
Increase in VA
Secondary Outcome Measures
Decrease in Macula Edema
Full Information
NCT ID
NCT00569569
First Posted
December 5, 2007
Last Updated
December 6, 2007
Sponsor
Rudolf Foundation Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00569569
Brief Title
Retaane® in Age-Related Macular Degeneration
Official Title
Retaane® in Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rudolf Foundation Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients treated with Retaane
Intervention Type
Drug
Intervention Name(s)
juxtascleral depot injection of Retaane
Intervention Description
juxtascleral depot injection of Retaane
Primary Outcome Measure Information:
Title
Increase in VA
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Decrease in Macula Edema
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, M.D.
Organizational Affiliation
no affiliation
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Retaane® in Age-Related Macular Degeneration
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