Advanced Characterization of Autosomal Dominant Optic Atr... | NCT01522638

Studies
Advanced Characterization of Autosomal Dominant Optic Atrophy

NCT01522638

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Jan 31, 2012Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Optic Atrophy, Autosomal Dominant

Interventions

Not provided

Countries

Denmark

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Jan 27, 2012

First Posted Date

Jan 31, 2012Estimated

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

Jan 27, 2012

Last Update Posted Date

Jan 31, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cecilia Rönnbäck, MD, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

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 determine the anatomy of the retina and the optic nerve in patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the study is to determine why patients with the same type of genetic material, i.e. the same mutation, have such large variations of symptoms, spanning from unaffected subjects to blindness. The project requires examination of both healthy and affected family members.

Detailed Description

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADOA		This group includes subjects diagnosed with autosomal dominant optic atrophy
Healthy subjects

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity		1 day
vessel caliber		1 day
OCT		1 day
Microperimetry		1 day
Lifestyle questionnaire		1 day
General checkup		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

Age below 8 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with autosomal dominant optic atrophy in Denmark.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Larsen, MD, Prof. DMSc	Glostrup University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University, Glostrup Hospital		Copenhagen		DK-2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25186535	Derived	Ronnback C, Larsen M. Macular sensitivity and fixation patterns in patients with autosomal dominant optic atrophy. Dan Med J. 2014 Sep;61(9):A4888.

ID	Term
D015418	Optic Atrophies, Hereditary
D009896	Optic Atrophy
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases