Diabetic Macular Oedema Clinical Trial
Official title:
An Open-label, Multi-centre, 12-month Study to Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus ('CONTROL' Study)
To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule.
To demonstrate the comparative effectiveness of Lucentis (ranibizumab) in patients with well
controlled compared to those with poorly controlled diabetes.
The primary endpoint for the study will be the mean change in best-corrected visual acuity
(BCVA) from baseline to Month 12.
Two groups of patients, based on HbA1c levels will be entered into the trial -
1. patients with a recent HbA1c level < 7.5 % (the 'well controlled' subgroup) and
2. patients with a recent HbA1c level ≥ 10.0% (the 'poorly controlled' subgroup).
Ranibizumab treatment will be administered over the 12-month period, initial 3 monthly
injections, followed by 'as needed' protocol using the following principles:
Monthly ranibizumab injections would be suspended when:
- No further BCVA improvement from treatment at the last 2 consecutive follow up visits OR
- BCVA letter score >84 (6/6) at the last 2 consecutive follow up visits
Monthly ranibizumab injections would be reinitiated when:
• Decrease in BCVA due to DME progression in the opinion of the investigator Laser treatment
could also be administered from 3 months after study initiation, according to the
investigators decision, in accordance with ETDRS guidelines, and at intervals of at least 3
months from the last treatment.
Visit schedule: Screening visit then monthly visits for 12 visits (total of 13 visits)
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