The SAME Study

Phase 4

Recruiting

• Conditions: Eye Diseases

• Registration Number: PACTR202001624880753
• Lead Sponsor: aseer Ally

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All diabetic patients with confirmed DMO – associated visual impairment and the following:
Snellen BCVA = 6/9 (equal and worse than 6/9); AND
CFT = 250µm on Heidelberg OCT (quality of OCT must be >20)

Exclusion Criteria

Patients who have previously received treatment for DMO (anti-VEGF; grid laser; or periocular or intravitreal steroids)
Macular oedema from any other causes such as vein occlusions, post cataract surgery and uveitis.
Patients with media opacities with a poor view of their fundus or poor quality OCT scans.
Patients with macular ischaemia on FA
Patients with other causes of poor vision such as corneal opacities, cataracts, media opacities, optic nerve dysfunction, retinal detachments and other macular/retinal pathologies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified