Evaluation of the Physician Education Component of the Ozurdex Risk Management Plan

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33655
• EU PAS number:
  EUPAS24861
• Study ID:
  33655
• Official title and acronym:
  Evaluation of the Physician Education Component of the Ozurdex Risk Management Plan
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  United Kingdom
• Study description:
  The survey objective is to assess the effectiveness of the educational material provided to physicians treating patients with Ozurdex by evaluating the physicians’ knowledge and understanding of the key information in the Ozurdex Injector’s Guide.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Planned: 14/11/2017

Actual: 14/11/2017

Study start date

Planned: 15/10/2018

Actual: 08/10/2018

Date of final study report

Planned: 29/03/2019

Actual: 12/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

Riskmgtsystem-Evaluation_Final Protocol_V3.0_15Mar2018_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CMO-EPI-EYE-0522