NCT00569569

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

December 7, 2007

Status Verified

December 1, 2007

First QC Date

December 5, 2007

Last Update Submit

December 6, 2007

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Increase in VA

    6 months

Secondary Outcomes (1)

  • Decrease in Macula Edema

    6 months

Study Arms (1)

1

EXPERIMENTAL

Patients treated with Retaane

Drug: juxtascleral depot injection of Retaane

Interventions

juxtascleral depot injection of RetaaneDRUG

juxtascleral depot injection of Retaane

1

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rejection of intravitreal injections
  • presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration

You may not qualify if:

  • conditions precluding judgement of the fundus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Susanne Binder, M.D.

    no affiliation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 7, 2007

Study Start

February 1, 2006

Study Completion

March 1, 2007

Last Updated

December 7, 2007

Record last verified: 2007-12