Status: Finalised First registered on: 17/07/2018
Last updated on: 14/02/2020
1. Study identification
EU PAS Register NumberEUPAS24861
Official titleEvaluation of the Physician Education Component of the Ozurdex Risk Management Plan
Study title acronym
Study typeOther: Physician Survey
Brief description of the studyThe 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableCMO-EPI-EYE-0522
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Mountford
First name William K
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/11/201714/11/2017
Start date of data collection15/10/201808/10/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report29/03/201912/03/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAllergan100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Mountford
First name William K
Address line 1Allergan
Address line 2Allergan Sales, LLC 
Address line 35 Giralda Farms 
CityMadison, NJ 
Postcode07940 
CountryUnited States
Phone number (incl. country code)12014278843 
Alternative phone number 
Fax number (incl. country code) 
Email address IR-CTRegistration@allergan.com
Public Enquiries
Title Dr 
Last name Team 
First name Clinical Registry 
Address line 1Allergan 
Address line 2Allergan Sales, LLC 
Address line 3Irvine 
CityCalifornia 
Postcode92612 
CountryUnited States 
Phone number (incl. country code)18772778566 
Alternative phone number 
Fax number (incl. country code) 
Email address IR-CTRegistration@allergan.com 
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