Assessment of the effect of intravitreal injections of bevacizumab using microperimetry and multifocal electroretinogram tests in previously untreated patients suffering from the swelling of the macular area of the retina due to diabetes.

Not Applicable

Conditions: Health Condition 1: H350- Background retinopathy and retinalvascular changesHealth Condition 2: H358- Other specified retinal disorders

Registration Number: CTRI/2023/10/058435

Lead Sponsor: All India Institute of Medical Sciences AIIMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Either gender & Age: 18 – 80 years

2.Diagnosed with treatment naïve CI-DME: (No prior treatment for DME with either of the following: intravitreal steroids, intravitreal anti-VEGFs, laser photocoagulation, vitrectomy, etc.)

3.Patients with the VA of 6/12 (20/60, 0.5) or less will be included in the study.

4.Patients with the central retinal thickening present in the cross-sectional SD-OCT of more than or equal to 320 µm in men and more than or equal to 305 µm in women (done on Heidelberg Engineering SPECTRALIS HRA+OCT, Heidelberg Engineering, Inc. 10 Forge Parkway Franklin, MA 02038) due to CI-DME will be included in the study.

5.Media clarity, pupillary dilatation and subjects’ co-operation sufficient for fundus imaging (OCT), BCVA, microperimetry, and multifocal ERG testing will be included in the study.

6.Only patients who are willing to participate in the study would be selected.

Exclusion Criteria

1.Patients with previously treated NCI-DME, CI-DME or proliferative diabetic retinopathy (PDR), or any other type of macular edema such as edema secondary to retinal vascular occlusions (RVO), Irvine-Gass syndrome, etc.

2.Patients with other associated retinal problems such as; vascular occlusions, age related macular degeneration (AMD), myopic degeneration, etc.

3.Any other ocular condition that might affect macular edema or alter visual acuity during the study such as; vitreomacular traction (VMT), etc.

4.Patients suffering from a significant cataract.

5.Patients on anti-glaucoma medication.

6.Pregnancy and breastfeeding.

7.Any active periocular or intraocular infection / inflammation (e.g., keratitis, scleritis, uveitis).

8.Patients not willing to participate in the study.