Phase 3
Completed N=239
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
Source: ClinicalTrials.gov NCT01135914 ↗Enrolled (actual)
239
Serious AEs
10.8%
Results posted
Oct 2014
Primary outcomePrimary: Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 — 8.2; 8.9; 0.3 Letters
Summary
To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12 |
8.2; 8.9; 0.3 | — |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 |
3.7; 5.3; 1.4; 5.6; 7.1; 0.9 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 |
422.1; 448.5; 458.0; -105.7; -108.9; -32.5 | — |
| SECONDARY Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline |
8.5; 9.3; 2.9; 11.4; 13.9; 1.5 | — |
| SECONDARY Percentage of Patients Achieving Gain of Letters From Baseline in BCVA |
61.4; 70.4; 40.3; 34.3; 52.1; 16.1 | — |
| SECONDARY National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12 |
85.21; 84.29; 78.20 | — |
| SECONDARY EuroQoL (EQ-5D) Utility Score at Month 12 |
0.88; 0.88; 0.87 | — |
| SECONDARY Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12 |
0.83; 0.78; 0.80 | — |
Eligibility Criteria
Inclusion Criteria
- Stable Type 1 or Type 2 diabetes mellitus
- Visual impairment due to focal or diffuse DME in at least one eye
Exclusion Criteria
- Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment
- Active eye infection or inflammation
- History of stroke, renal failure or uncontrolled hypertension
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01135914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.