Observational Study to Evaluate the Safety of Ozurdex in the Treatment of Diabetic Macular Edema (DME
Phase 4
- Conditions
- Health Condition 1: null- Diabetic Macular Edema
- Registration Number
- CTRI/2017/04/008396
- Lead Sponsor
- Allergan Healthcare India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants with Adverse Events and Serious Adverse EventsTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI