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The SAME Study

The South African Macular oEdema in diabetics study (The SAME Study): A prospective randomized non-inferiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202001624880753
Enrollment
120
Registered
2020-01-06
Start date
2017-11-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Eye Diseases

Interventions

Bevacizumab

Sponsors

Naseer Ally
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Non-inferiority margin 5 ETDRS letters of the number of letters improved from baseline to the 1 year and 2 year visits.

Secondary

MeasureTime frame
Central foveal thickness difference between the 2 groups

Countries

South Africa

Contacts

Public ContactSarah Ismail

Coinvestigator

sarahismail77@gmail.com+27724506182

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026