Observational Study to Evaluate the Safety of Ozurdex in the Treatment of Diabetic Macular Edema (DME

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/04/008396
• Date of registration: 24-04-2017
• Prospective Registration: No
• Primary sponsor: Allergan Healthcare India Pvt Ltd
• Public title: Observational Study to Evaluate the Safety of Ozurdex in the Treatment of Diabetic Macular Edema (DME
• Scientific title: An Observational, Prospective Post-Marketing Surveillance Program to Evaluate the Safety 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
• Date of first enrolment: 05-12-2016
• Target sample size: 250
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16690
• Study type: PMS
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Post Marketing Surveillance

Countries of recruitment

India

Contacts

• Name: DrThirumalai Velu MD
• Affiliation: Allergan Inc

• Name: DrThirumalai Velu MD
• Affiliation: Allergan Inc

Key inclusion & exclusion criteria

Inclusion criteria: Patients who are scheduled to receive at least one intravitreal Ozurdex® injection for the treatment of visual impairment due to Diabetic Macular Edema. The patient has signed a written informed consent.
Exclusion criteria: Patients for whom Ozurdex is contraindicated:

1. Ocular or periocular infections

2. Glaucoma

3. Torn or ruptured posterior lens capsule

4. Hypersensitivity

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Diabetic Macular Edema

Intervention(s)

Intervention1: NIL: NIL
Control Intervention1: NIL: NIL

Primary Outcome(s)

Number of participants with Adverse Events and Serious Adverse EventsTimepoint: 1 year

Secondary Outcome(s)

NILTimepoint: NIL

Secondary ID(s)

1491-401-008, Version 1, 09Sept2016

Source(s) of Monetary Support

Allergan PLC Allergan Healthcare India Private Limited Level 2, Prestige Obelisk No 3, Kasturba Road Bangalore 560 001

Ethics review

Status: Approved
Approval date: 10/01/2017
Contact:

LV Prasad Eye Institute

Status: Approved
Approval date: 14/01/2017
Contact:

Chaithanya Eye Hospital and Research Institute

Status: Approved
Approval date: 20/01/2017
Contact:

LV Prasad Eye Institute

Status: Approved
Approval date: 30/01/2017
Contact:

KIMS Hospital

Status: Approved
Approval date: 03/02/2017
Contact:

Sankara Eye Hospital

Status: Approved
Approval date: 21/02/2017
Contact:

Postgraduate Institute of Medical Education & Research, Advanced Eye Center

Status: Approved
Approval date: 10/03/2017
Contact:

Retina Foundation

Status: Approved
Approval date: 22/05/2017
Contact:

Dr Shroff Charity Eye Hospital

Status: Not Applicable
Approval date:
Contact:

Bankers Retina Clinic and Laser Centre

Status: Not Applicable
Approval date:
Contact:

Dr. Daljit Singh Eye Hospital

Status: Not Applicable
Approval date:
Contact:

Eydox Eye Hospital Pvt. Ltd.

Status: Not Applicable
Approval date:
Contact:

Geetasri Retina Institute

Status: Not Applicable
Approval date:
Contact:

Insight Eye Clinic

Status: Not Applicable
Approval date:
Contact:

M.M.Joshi Eye Institute

Status: Not Applicable
Approval date:
Contact:

Mela Mal Sood Rotary Eye Hospital

Status: Not Applicable
Approval date:
Contact:

Neo Retina Eye Care Institute

Status: Not Applicable
Approval date:
Contact:

Saswade Netra Rughanalaya & Laser centre

Status: Not Applicable
Approval date:
Contact:

Sudhalkar Eye Hospital and Retina Centre

Status: Not Applicable
Approval date:
Contact:

Tirupati Eye Centre