Retaane® in Age-Related Macular Degeneration | NCT00569569

Studies
Retaane® in Age-Related Macular Degeneration

NCT00569569

Sponsor

Rudolf Foundation Clinic

Status

Completed

Last Update Posted

Dec 7, 2007Estimated

Enrollment

20Actual

Phase

Phase 2Phase 3

Conditions

Age Related Macular Degeneration

Interventions

juxtascleral depot injection of Retaane

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 6, 2007

First Posted Date

Dec 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2007

Last Update Posted Date

Dec 7, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Patients treated with Retaane	Drug: juxtascleral depot injection of Retaane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
juxtascleral depot injection of Retaane	Drug	juxtascleral depot injection of Retaane	1

Measure	Description	Time Frame
Increase in VA		6 months

Measure	Description	Time Frame
Decrease in Macula Edema		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Susanne Binder, M.D.	no affiliation	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

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Browse Branches

Not provided