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

An Observational, Prospective Post-Marketing Surveillance Program to Evaluate the Safety Profile of Intravitreal OzurdexÂ® 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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/04/008396

Enrollment

250

Registered

2017-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic Macular Edema

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients for whom Ozurdex is contraindicated: 1. Ocular or periocular infections 2. Glaucoma 3. Torn or ruptured posterior lens capsule 4. Hypersensitivity

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse Events and Serious Adverse EventsTimepoint: 1 year	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDrThirumalai Velu MD

Allergan Inc

S_Thirumalaivelu@allergan.com91-80-40707216

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026