Trial · NCT02259088
A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
NCT02259088, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients. Trials, record NCT02259088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02259088
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
- NCT number
- NCT02259088
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 384 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetic Macular Edema, Visual Impairment
- Interventions
- Ranibizumab (RFB002), Laser, Sham injection, Sham laser
- First posted
- 2014-10-08
- Last updated
- 2019-02-01
- Results first posted
- 2019-02-01
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | Baseline, Monthly from Month 1 through 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. 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. |
| Secondary | Mean Change From Baseline in BCVA (Letters) at Each Visit | Baseline, Monthly from Month 1 through 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. |
| Secondary | Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit | Baseline, Monthly from Month 1 through Month 12 | 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. |
| Secondary | Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12 | Baseline, 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. |
| Secondary | Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12 | Baseline, 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. |
| Secondary | Percentage of Patients With BCVA ≥ 73 Letters at Month 12 | 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. |
| Secondary | Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3 | Monthly from Month 3 through 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. 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. |
| Secondary | Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score | Baseline, Month 6, Month 12 | 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. |
| Secondary | Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12 | Baseline, Month 6, 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. |
| Secondary | Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12 | Baseline, Month 6, 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | Baseline, Monthly from Month 1 through Month 12 | Full Analysis Set (FAS). Missing values imputed by the mean value last observation carried forward (MV-LOCF). | letters | MEAN |
| SECONDARY | Mean Change From Baseline in BCVA (Letters) at Each Visit | Baseline, Monthly from Month 1 through Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | letters | MEAN |
| SECONDARY | Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit | Baseline, Monthly from Month 1 through Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | micrometers | MEAN |
| SECONDARY | Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12 | Baseline, Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12 | Baseline, Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With BCVA ≥ 73 Letters at Month 12 | Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | percentage of participants | NUMBER |
| SECONDARY | Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3 | Monthly from Month 3 through Month 12 | Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). | letters | MEAN |
| SECONDARY | Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score | Baseline, Month 6, Month 12 | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12 | Baseline, Month 6, Month 12 | Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit. | units on a scale | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | Ranibizumab (RFB002) | 6.8 | Standard Deviation 6.58 | letters | |
| Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12 | Laser | 1.1 | Standard Deviation 7.73 | letters | |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Ranibizumab (RFB002) | Change from Baseline at Month 1 | 4.0 | Standard Deviation 5.59 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Laser | Change from Baseline at Month 1 | -0.9 | Standard Deviation 5.50 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Ranibizumab (RFB002) | Change from Baseline at Month 2 | 5.8 | Standard Deviation 6.44 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Laser | Change from Baseline at Month 2 | 0.0 | Standard Deviation 8.08 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Ranibizumab (RFB002) | Change from Baseline at Month 3 | 6.9 | Standard Deviation 6.91 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Laser | Change from Baseline at Month 3 | 1.1 | Standard Deviation 9.18 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Ranibizumab (RFB002) | Change from Baseline at Month 4 | 6.6 | Standard Deviation 7.23 | letters |
| Mean Change From Baseline in BCVA (Letters) at Each Visit | Laser | Change from Baseline at Month 4 | 0.0 | Standard Deviation 11.64 | letters |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab (RFB002) | 307 | |
| Overall Study | STARTED | Laser | 77 | |
| Overall Study | Full Analysis Set | Ranibizumab (RFB002) | 307 | |
| Overall Study | Full Analysis Set | Laser | 77 | |
| Overall Study | Treated (Safety Analysis Set) | Ranibizumab (RFB002) | 307 | |
| Overall Study | Treated (Safety Analysis Set) | Laser | 75 | |
| Overall Study | COMPLETED | Ranibizumab (RFB002) | 279 | |
| Overall Study | COMPLETED | Laser | 63 | |
| Overall Study | NOT COMPLETED | Ranibizumab (RFB002) | 28 | |
| Overall Study | NOT COMPLETED | Laser | 14 |
Source ClinicalTrials.gov
Adverse events170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ranibizumab (RFB002) | 10 | 307 | |
| other | Anaemia | Blood and lymphatic system disorders | Laser | 0 | 75 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Ranibizumab (RFB002) | 11 | 307 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Laser | 1 | 75 | |
| other | Dry eye (Fellow eye) | Eye disorders | Ranibizumab (RFB002) | 10 | 307 | |
| other | Dry eye (Fellow eye) | Eye disorders | Laser | 1 | 75 | |
| other | Dry eye (Study eye) | Eye disorders | Ranibizumab (RFB002) | 11 | 307 | |
| other | Dry eye (Study eye) | Eye disorders | Laser | 1 | 75 | |
| other | Vitreous haemorrhage (Fellow eye) | Eye disorders | Ranibizumab (RFB002) | 11 | 307 | |
| other | Vitreous haemorrhage (Fellow eye) | Eye disorders | Laser | 3 | 75 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab (RFB002) | ||
| Total, all-cause mortality | Laser | ||
| Total, other adverse events | Ranibizumab (RFB002) | 116 | 307 |
| Total, other adverse events | Laser | 30 | 75 |
| Total, serious adverse events | Ranibizumab (RFB002) | 57 | 307 |
| Total, serious adverse events | Laser | 15 | 75 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ranibizumab (RFB002) vs Laser: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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