A Phase 3 interventional study of Ranibizumab (RFB002) and Laser in Diabetic Macular Edema and Visual Impairment, sponsored by Novartis Pharmaceuticals. Completed at 28 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-01.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.
308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.
This study's enrollment of 384 is above the median of 66 across 211 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser
Drug: Ranibizumab (RFB002) · Procedure: Sham laser
Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections
Procedure: Laser · Drug: Sham injection
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
Also known as: Lucentis
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Imitation of an active laser
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in BCVA (Letters) at Each Visit
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Month 12
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Month 12
Percentage of Patients With BCVA ≥ 73 Letters at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.
Time frame: Month 12
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged \[(Month4+Month5+...+Month12)/9\],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Monthly from Month 3 through Month 12
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.
Time frame: Baseline, Month 6, Month 12
Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.
Time frame: Monthly from Month 3 through Month 12
| Milestone | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Started | 307 | 77 |
| Full analysis set | 307 | 77 |
| Treated (safety analysis set) | 307 | 75 |
| Completed | 279 | 63 |
| Not completed | 28 | 14 |
| Withdrew: Adverse event | 6 | 4 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Physician decision | 5 | 2 |
| Withdrew: Protocol deviation | 5 | 0 |
| Withdrew: Subject/guardian decision | 8 | 8 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
| letters | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | 6.8 ± 6.58 | 1.1 ± 7.73 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
| letters | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 1 | 4.0 ± 5.59 | -0.9 ± 5.50 |
| Change from Baseline at Month 2 | 5.8 ± 6.44 | 0.0 ± 8.08 |
| Change from Baseline at Month 3 | 6.9 ± 6.91 | 1.1 ± 9.18 |
| Change from Baseline at Month 4 | 6.6 ± 7.23 | 0.0 ± 11.64 |
| Change from Baseline at Month 5 | 6.8 ± 7.41 | 0.6 ± 10.61 |
| Change from Baseline at Month 6 | 6.8 ± 8.00 | 0.3 ± 11.01 |
| Change from Baseline at Month 7 | 6.8 ± 7.95 | 1.3 ± 10.13 |
| Change from Baseline at Month 8 | 7.4 ± 8.12 | 1.9 ± 9.69 |
| Change from Baseline at Month 9 | 7.3 ± 8.18 | 1.8 ± 9.33 |
| Change from Baseline at Month 10 | 7.2 ± 8.45 | 1.6 ± 9.23 |
| Change from Baseline at Month 11 | 7.8 ± 8.55 | 1.7 ± 9.35 |
| Change from Baseline at Month 12 | 7.8 ± 8.72 | 2.5 ± 8.78 |
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
| micrometers | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 1 | -126.7 ± 140.59 | -33.1 ± 113.34 |
| Change from Baseline at Month 2 | -141.3 ± 146.15 | -48.8 ± 133.22 |
| Change from Baseline at Month 3 | -154.2 ± 147.94 | -58.5 ± 157.30 |
| Change from Baseline at Month 4 | -130.4 ± 152.60 | -72.6 ± 149.13 |
| Change from Baseline at Month 5 | -141.0 ± 153.28 | -72.3 ± 150.45 |
| Change from Baseline at Month 6 | -146.2 ± 154.87 | -72.9 ± 152.47 |
| Change from Baseline at Month 7 | -138.4 ± 161.04 | -72.4 ± 150.86 |
| Change from Baseline at Month 8 | -146.9 ± 154.68 | -81.8 ± 151.89 |
| Change from Baseline at Month 9 | -142.4 ± 156.03 | -80.9 ± 157.69 |
| Change from Baseline at Month 10 | -137.6 ± 152.73 | -82.9 ± 166.16 |
| Change from Baseline at Month 11 | -144.8 ± 159.87 | -88.1 ± 170.11 |
| Change from Baseline at Month 12 | -146.5 ± 157.61 | -85.9 ± 166.60 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
| percentage of participants | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Gain of ≥ 10 letters | 40.6 | 20.0 |
| Gain of ≥ 15 letters | 18.5 | 8.0 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
| percentage of participants | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Loss of < 10 letters | 97.0 | 89.3 |
| Loss of <15 letters | 99.0 | 97.3 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.
| percentage of participants | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Percentage of Patients With BCVA ≥ 73 Letters at Month 12 | 36.0 | 21.3 |
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged \[(Month4+Month5+...+Month12)/9\],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
| letters | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Month 3 | 66.4 ± 10.66 | 59.2 ± 12.63 |
| Average Change from Baseline Month 4 to Month 12 | 0.3 ± 4.51 | 0.2 ± 6.08 |
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 2.5 ± 13.54 | 0.5 ± 13.17 |
| Change from Baseline at Month 12 | 0.6 ± 14.99 | -0.4 ± 15.89 |
General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | -1.5 ± 22.32 | -0.4 ± 21.81 |
| Change from Baseline at Month 12 | -2.3 ± 24.34 | -4.3 ± 26.56 |
General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 6.2 ± 18.77 | 4.7 ± 19.58 |
| Change from Baseline at Month 12 | 5.9 ± 18.12 | 5.9 ± 20.06 |
Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 2.0 ± 16.68 | 2.2 ± 17.26 |
| Change from Baseline at Month 12 | 0.2 ± 21.55 | 1.6 ± 20.35 |
Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 1.4 ± 20.51 | 5.5 ± 22.38 |
| Change from Baseline at Month 12 | -2.3 ± 25.07 | 3.1 ± 27.64 |
Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | -1.5 ± 20.71 | 1.5 ± 20.89 |
| Change from Baseline at Month 12 | -0.3 ± 19.89 | 4.1 ± 22.72 |
Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 5.6 ± 23.81 | -1.7 ± 24.20 |
| Change from Baseline at Month 12 | 0.6 ± 24.64 | -3.4 ± 21.93 |
Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 5.4 ± 20.79 | -2.8 ± 19.35 |
| Change from Baseline at Month 12 | 1.6 ± 23.74 | -5.5 ± 21.89 |
Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 2.1 ± 19.24 | -1.5 ± 15.31 |
| Change from Baseline at Month 12 | -0.8 ± 21.58 | -3.2 ± 18.51 |
Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 1.8 ± 23.07 | -0.2 ± 23.58 |
| Change from Baseline at Month 12 | 1.3 ± 25.05 | 0.6 ± 23.32 |
Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 1.4 ± 27.05 | -0.4 ± 24.24 |
| Change from Baseline at Month 12 | 0.4 ± 27.62 | -1.4 ± 28.36 |
Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 0.2 ± 27.95 | -4.3 ± 27.53 |
| Change from Baseline at Month 12 | 0.9 ± 30.47 | -5.3 ± 27.87 |
Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.
| units on a scale | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Change from Baseline at Month 6 | 2.8 ± 15.87 | 2.8 ± 20.52 |
| Change from Baseline at Month 12 | -0.2 ± 12.29 | 4.5 ± 27.98 |
A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.
| retreatments | Ranibizumab (RFB002) |
|---|---|
| Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward | 1.6 ± 0.64 |
Collected over Day 1 through study completion, an average of 1 year. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranibizumab (RFB002) | — | 57/307 (18.6%) | 116/307 (37.8%) |
| Laser | — | 15/75 (20%) | 30/75 (40%) |
| Event | Ranibizumab (RFB002) | Laser |
|---|---|---|
| Diabetic retinal oedema (Fellow eye)Eye disorders | 1/307 | 2/75 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 4/307 | 2/75 |
| Diabetic footSkin and subcutaneous tissue disorders | 1/307 | 2/75 |
| Coronary artery diseaseCardiac disorders | 5/307 | 0/75 |
| Diabetic nephropathyRenal and urinary disorders | 5/307 | 1/75 |
| Retinal detachment (Fellow eye)Eye disorders | 0/307 | 1/75 |
| Vitreous haemorrhage (Fellow eye)Eye disorders | 3/307 | 1/75 |
| Vitreous haemorrhage (Study eye)Eye disorders | 0/307 | 1/75 |
| AscitesGastrointestinal disorders | 0/307 | 1/75 |
| Hepatic cirrhosisHepatobiliary disorders | 0/307 | 1/75 |
| Event | Ranibizumab (RFB002) | Laser |
|---|---|---|
| HypertensionVascular disorders | 17/307 | 9/75 |
| NasopharyngitisInfections and infestations | 20/307 | 7/75 |
| Upper respiratory tract infectionInfections and infestations | 26/307 | 2/75 |
| CoughRespiratory, thoracic and mediastinal disorders | 18/307 | 2/75 |
| Alanine aminotransferase increasedInvestigations | 3/307 | 4/75 |
| Intraocular pressure increased (Study eye)Investigations | 16/307 | 0/75 |
| Urinary tract infectionInfections and infestations | 15/307 | 3/75 |
| Vitreous haemorrhage (Fellow eye)Eye disorders | 11/307 | 3/75 |
| Vitreous haemorrhage (Study eye)Eye disorders | 5/307 | 3/75 |
| HyperlipidaemiaMetabolism and nutrition disorders | 9/307 | 3/75 |
| Age, Continuous(years) | Ranibizumab (RFB002) | Laser | Total |
|---|---|---|---|
| Mean | 58.6 ± 8.70 | 59.0 ± 9.19 | 58.7 ± 8.79 |
| Sex: Female, Male(Participants) | Ranibizumab (RFB002) | Laser | Total |
|---|---|---|---|
| Female | 168 | 38 | 206 |
| Male | 139 | 39 | 178 |
| Best Corrected Visual Acuity(letters) | Ranibizumab (RFB002) | Laser | Total |
|---|---|---|---|
| Mean | 59.6 ± 10.53 | 58.2 ± 9.43 | 59.3 ± 10.32 |
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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