To compare the effect of two different intraocular injections in diabetic related retinal disease

Phase 4

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/09/058134
• Lead Sponsor: Dr Vipin Rana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients >18 years old with visual impairment due to DME.

2. Patients with type 1 or type 2 diabetes mellitus and Hba1c of <10% at screening.

3. Patient or legally acceptable representative willing to voluntarily provide signed informed consent for participation in the study.

Exclusion Criteria

1. Patient with existing or suspected ocular or periocular infection in the study eye.

2. Patient with uncontrolled glaucoma defined as intraocular pressure >25 mmhg despite treatment with antiglaucoma medication, or according to investigators judgement.

3. Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.

4. Active proliferative diabetic retinopathy in the study eye as per investigator.

5. Previous treatment with any anti-vegf drugs or investigational drugs in the study eye.

6.Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 month period prior to baseline.

7. Intraocular surgery including YAG laser in the study eye during the 3 month period prior to baseline.

8. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified