Long-term Follow-up of Subfoveal Neovascular AMD | NCT01608113

Studies
Long-term Follow-up of Subfoveal Neovascular AMD

NCT01608113

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

May 30, 2012Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Exudative Age-related Macular Degeneration

Interventions

Not provided

Countries

Austria

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

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

May 25, 2012

First Posted Date

May 30, 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

May 25, 2012

Last Update Posted Date

May 30, 2012Estimated

Description Module

Brief Summary

Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal anti-VEGF and subsequently PRN, will be included in this study. Patients will be investigated for the first 2 years monthly and subsequently according to disease activity but at least every two months. Patients will be examined with 4m BCVA ETDRS distance visual acuity, reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score, microperimetry and HD-OCT.

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

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term visual function performance		four years

Secondary Outcomes

Measure	Description	Time Frame
change of morphological alterations assessed by SD-OCT		four years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

treatment naive subfoveal AMD, written informed consent, able to read

Exclusion Criteria:

choroidal neovascularisation due to other ocular diseases, mature cataract

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering on treatment naive subfoveal neovascular age-related macular degeneration

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher G Kiss, MD	Medical University Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology Medical University of Vienna	Recruiting	Vienna	State of Vienna	1190	Austria