Post-Authorization Safety Study of OZURDEX® (Dexamethasone Intravitreal Implant): A Prospective Observational Study to Evaluate Long-Term Safety in Real-World Clinical Practice (CONSTANCE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34210
• EU PAS number:
  EUPAS15160
• Study ID:
  34210
• Official title and acronym:
  Post-Authorization Safety Study of OZURDEX® (Dexamethasone Intravitreal Implant): A Prospective Observational Study to Evaluate Long-Term Safety in Real-World Clinical Practice (CONSTANCE)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  United Kingdom
• Study description:
  This is a multi-center, prospective, observational study to evaluate the long-term safety profile of OZURDEX® in adult patients diagnosed with macular oedema following CRVO or BRVO or patients with non-infectious posterior segment uveitis, under conditions of routine medical practice in accordance with the product’s Summary of Product Characteristics. The study will target recruitment of 650 patients, 500 with RVO and 150 with non-infectious posterior segment uveitis, with patients receiving >2 implants constituting at least 40% (N≥260) of the study sample. As an observational study, all treatment decisions are at the discretion of the patient’s health care provider and are not defined or mandated by the study design or protocol. Patients will receive OZURDEX® under routine clinical practice, and if they elect to participate in the study (i.e. provide informed consent), they will be followed for two years from study enrollment. The research objectives of this study are as follows: Primary objective: To evaluate the long-term safety of OZURDEX®, including the identified and potential risks as listed in the risk management plan, in patients with macular oedema following RVO or non-infectious posterior segment uveitis who are treated with OZURDEX® under conditions of routine medical practice. Secondary objective: To describe treatment patterns for patients receiving OZURDEX® for the treatment of macular oedema following RVO or non-infectious posterior segment uveitis in real-world clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World & Late Phase Research (RWLPR), Quintiles

France

Multiple centres: 75 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/01/2011

Actual: 01/01/2011

Study start date

Planned: 29/03/2012

Actual: 29/03/2012

Date of final study report

Planned: 22/09/2016

Actual: 30/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan

Study protocol

Initial protocol

Allergan_Ozurdex_PASS_protocol_17Jan2012_v1.6_Final_signed_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

206207-025