Phase 4
Completed N=135
Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Source: ClinicalTrials.gov NCT02366468 ↗Enrolled (actual)
135
Serious AEs
25.9%
Results posted
Jan 2019
Primary outcomePrimary: Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12) — 67.4; 65.1; 73.5; 73.8 Letters — p=0.002
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12) |
67.4; 65.1; 73.5; 73.8; 6.1; 8.6 | 0.002 sig |
| SECONDARY Number of Visits |
12.7; 12.9 | — |
| SECONDARY Number of Injections |
8.4; 7.8 | — |
| SECONDARY Number of Treatment Free Intervals |
1.6; 1.7 | — |
| SECONDARY Mean Change in Central Subfield Retinal Thickness (CSRT) |
420.0; 431.0; 313.3; 320.6; -106.7; -110.4 | 0.620 |
| SECONDARY Mean Change of Foveal Center Point Thickness |
398.8; 405.0; 273.3; 280.6; -125.6; -124.4 | 0.925 |
| SECONDARY Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale |
7; 7; 3; 4; 6; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
- Patients with visual impairment due to DME in at least one eye
- BCVA ≥ 24 and ≤ 78 letters in the study eye
Exclusion Criteria
- Active intraocular inflammation
- Any active infection in either eye at the
- Structural damage within 0.5 disc diameter of the center of the macula in the study eye
- Uncontrolled glaucoma in either eye at screening
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02366468). 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.