Fundus Autofluorescence Imaging in Age-related Macular De... | NCT00393692

Studies
Fundus Autofluorescence Imaging in Age-related Macular Degeneration Using Confocal Scanning Laser Ophthalmoscopy

NCT00393692

Sponsor

University Hospital, Bonn

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

700Actual

Phase

Not provided

Conditions

Age-related Macular Degeneration

Interventions

Not provided

Countries

Germany

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

Oct 2018

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

Aug 2000

Primary Completion Date

Apr 2016Actual

Completion Date

Oct 2018Actual

First Submitted Date

Oct 26, 2006

First Submission Date that Met QC Criteria

Oct 26, 2006

First Posted Date

Oct 30, 2006Estimated

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

Oct 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

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 purpose of this study is to define phenotypic variations in atrophic Age-Related Macular Degeneration (AMD) and to identify predictive factors for disease progression based on fundus autofluorescence imaging.

Detailed Description

Age-related macular degeneration (AMD) is the leading cause of legal blindness in the industrialized world beyond 50 years of age. Ageing changes of the retinal pigment epithelium (RPE) play a key role in the pathogenesis of the disease. In postmitotic RPE cells autofluorescent lipofuscin granules accumulate with age in the lysosomal compartment mainly as a byproduct of constant phagocytosis of membranous disks shed from photoreceptor outer segments. With the advent of confocal scanning laser ophthalmoscopy fundus autofluorescence mediated by RPE-lipofuscin accumulation can be visualized in vivo: We plan to identify fundus autofluorescence changes as predictive factors for the development of late stage manifestations and their variation over time. Furthermore, we plan to determine the effect of increased focal accumulations of autofluorescent material on retinal sensitivity using fundus perimetry. Examination of human donor eyes with AMD will allow for correlation of fundus autofluorescence alterations in vivo and in vitro. These investigations will be performed not only to better understand the role of lipofuscin accumulation in AMD but also to manipulate these mechanisms for both experimental and therapeutic ends.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of geographic atrophy size to baseline		36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be considered reliable, willing and able to give informed consent.
Age >50 years (male or female)
Must have age-related macular degeneration in at least one eye
Clear media to allow imaging

Exclusion Criteria:

any history of retinal surgery, including laser treatment, photodynamic therapy, radiation or intravitreal injections
history of retinal vascular occlusions
any concurrent intraocular condition that, in the opinion of the investigator, could exclude the patient from the medical or ethical point of view

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with unilateral or bilateral geographic atrophy due to AMD, aged 50 years and older. German population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank G Holz, MD	University of Bonn	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, University of Aachen		Aachen		52074	Germany
Department of Ophthalmology, University of Heidelberg

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9987631	Background	Holz FG, Bellmann C, Margaritidis M, Schutt F, Otto TP, Volcker HE. Patterns of increased in vivo fundus autofluorescence in the junctional zone of geographic atrophy of the retinal pigment epithelium associated with age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 1999 Feb;237(2):145-52. doi: 10.1007/s004170050209.
11274085

ID	Type	Description	Link
DFG Priority Program AMD
SPP 1088
Ho 1926/1-3
Ho 1926/3-1
Ma 1723/1-1

ID	Term
D008268	Macular Degeneration
D057092	Geographic Atrophy

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases