Phase 3
N=384
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
Diabetic Macular Edema · Visual Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02259088 ↗Enrolled (actual)
384
Serious AEs
18.9%
Results posted
Feb 2019
Primary outcome: Primary: Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 — 6.8; 1.1 letters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranibizumab (RFB002) (Drug); Laser (Procedure); Sham injection (Drug); Sham laser (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 |
6.8; 1.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline in BCVA (Letters) at Each Visit |
4.0; -0.9; 5.8; 0.0; 6.9; 1.1 | — |
| SECONDARY Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit |
-126.7; -33.1; -141.3; -48.8; -154.2; -58.5 | — |
| SECONDARY Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12 |
40.6; 20.0; 18.5; 8.0 | — |
| SECONDARY Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12 |
97.0; 89.3; 99.0; 97.3 | — |
| SECONDARY Percentage of Patients With BCVA ≥ 73 Letters at Month 12 |
36.0; 21.3 | — |
| SECONDARY Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3 |
66.4; 59.2; 0.3; 0.2 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score |
2.5; 0.5; 0.6; -0.4 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12 |
-1.5; -0.4; -2.3; -4.3 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12 |
6.2; 4.7; 5.9; 5.9 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12 |
2.0; 2.2; 0.2; 1.6 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12 |
1.4; 5.5; -2.3; 3.1 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12 |
-1.5; 1.5; -0.3; 4.1 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12 |
5.6; -1.7; 0.6; -3.4 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12 |
5.4; -2.8; 1.6; -5.5 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12 |
2.1; -1.5; -0.8; -3.2 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12 |
1.8; -0.2; 1.3; 0.6 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12 |
1.4; -0.4; 0.4; -1.4 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12 |
0.2; -4.3; 0.9; -5.3 | — |
| SECONDARY Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12 |
2.8; 2.8; -0.2; 4.5 | — |
| SECONDARY Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward |
1.6 | — |
Summary
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
Eligibility Criteria
Key Inclusion Criteria
- Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
- Stable medication for diabetes within 3 months prior to Visit 1
- Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters
Key Exclusion Criteria
- Stroke or myocardial infarction less than 3 months prior to screening visit
- Uncontrolled hypertension
- Active ocular infection or intraocular inflammation in any eye
- Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
- Active proliferative diabetic retinopathy in study eye
- Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
- Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
- History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
Data sourced from ClinicalTrials.gov (NCT02259088). 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.