An Observational, Prospective Post-Marketing Surveillance Program to Evaluate theSafety Profile of Intravitreal Ozurdex® in the Treatment of Visual Impairment due to Diabetic Macular Edema by Actively Identifying and Evaluating the Occurrence of Adverse Events and Serious Adverse Events information

Study identification

• EU PAS number:
  EUPAS16156
• Study ID:
  23957
• Official title and acronym:
  An Observational, Prospective Post-Marketing Surveillance Program to Evaluate theSafety Profile of Intravitreal Ozurdex® in the Treatment of Visual Impairment due to Diabetic Macular Edema by Actively Identifying and Evaluating the Occurrence of Adverse Events and Serious Adverse Events information
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  Objectives The objective of the study is to evaluate the safety profile of Ozurdex® by actively identifying and evaluating the occurrence of AEs and SAEs for 1 year period in adult Indian patients (≥18 years of age) who will be receiving at least one intravitreal Ozurdex® injection for the treatment of visual impairment due to DME. Study design Observational, prospective post marketing surveillance (PMS) program to evaluate the safety profile of intravitreal Ozurdex® by actively identifying and evaluating the occurrence of AEs and SAEs information. Study Population Indian adult patients aged ≥18 years who receive at least on intravitreal Ozurdex injection for the treatment of visual impairment due to DME Study Sites Identification of relevant prescribing physicians that located across the country will be done. Identified prescribing physicians will be invited to participate in the study Patient Recruitment Patients of physician that have been trained on the conduct of the study will be contracted to recruit eligible patients. Patients will be enrolled in the study after informed consent and Ozurdex implanatation Sample Size Approximately 250 patients from about 20 sites in India Study Duration One year after study start date Data Collection Study physicians will fill out CRFs for each of their enrolled patients. Analysis Only descriptive data analysis will conducted.
• Study status:
  Finalised

Research institutions and networks

Institutions

ClinTec

Study timelines

Date when funding contract was signed

Actual: 30/08/2016

Study start date

Planned: 30/09/2016

Actual: 05/12/2016

Date of final study report

Planned: 01/04/2018

Actual: 06/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Regulatory

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

Other study registration identification numbers and links

1491-401-008