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
- Sponsor
- Marsden Eye Specialists
- Study ID
- NCT03495765
- Phase
- PHASE3
- Status
- Completed
Conditions
- Diabetic Macular Oedema
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Ranibizumab — DRUGRanibizumab 0.5mcg via intravitreal injection to study eye up to monthly
Study Details
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.
Key Dates
- First listed
- Apr 12, 2018
- Start date
- Mar 31, 2011
- Status verified
- Apr 2018
- Primary completion
- Jan 1, 2017
- Completion
- Jan 1, 2017
Study Design
- Enrollment
- 160 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Well controlledEligibile people with diabetic macular oedema and HBA1C \< 7.5
- Active Comparator: Poorly controlledeligible people with Diabetic macular oedema and HBAIC \>10.0
Primary Outcome Measure
The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 12. [ Time Frame: 12 months ]