Trial · NCT01131585
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
NCT01131585, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2012-08-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Ranibizumab in Diabetic Macular Edema. Trials, record NCT01131585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01131585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
- NCT number
- NCT01131585
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 128 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Visual Impairment Due to Diabetic Macular Edema
- Interventions
- Active laser photocoagulation, Sham injections, Ranibizumab 0.5 mg
- First posted
- 2010-05-27
- Last updated
- 2012-08-30
- Other registries' IDs
- eudract:2010-018852-29
- Results first posted
- 2012-08-17
- Limitations and caveats
- Early study termination due to European drug approval.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 12 months | Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 12 months | Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months. | Letters | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Active Laser Photocoagulation and Ranibizumab | 6.5 | Standard Deviation 8.6 | Letters | |
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Active Laser Photocoagulation and Sham Injection | 1.4 | Standard Deviation 7.3 | Letters |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Laser Photocoagulation and Ranibizumab | 85 | |
| Overall Study | STARTED | Active Laser Photocoagulation and Sham Injection | 43 | |
| Overall Study | COMPLETED | Active Laser Photocoagulation and Ranibizumab | 0 | |
| Overall Study | COMPLETED | Active Laser Photocoagulation and Sham Injection | 0 | |
| Overall Study | NOT COMPLETED | Active Laser Photocoagulation and Ranibizumab | 85 | |
| Overall Study | NOT COMPLETED | Active Laser Photocoagulation and Sham Injection | 43 |
Source ClinicalTrials.gov
Adverse events62
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 | EYE IRRITATION (Study eye) | Eye disorders | Active Laser Photocoagulation and Ranibizumab | 5 | 85 | 5 |
| other | EYE IRRITATION (Study eye) | Eye disorders | Active Laser Photocoagulation and Sham Injection | 0 | 43 | 0 |
| other | EYE PAIN (Study eye) | Eye disorders | Active Laser Photocoagulation and Ranibizumab | 13 | 85 | 13 |
| other | EYE PAIN (Study eye) | Eye disorders | Active Laser Photocoagulation and Sham Injection | 4 | 43 | 4 |
| other | LACRIMATION INCREASED (Study eye) | Eye disorders | Active Laser Photocoagulation and Ranibizumab | 5 | 85 | 5 |
| other | LACRIMATION INCREASED (Study eye) | Eye disorders | Active Laser Photocoagulation and Sham Injection | 1 | 43 | 1 |
| other | NASOPHARYNGITIS | Infections and infestations | Active Laser Photocoagulation and Ranibizumab | 13 | 85 | 13 |
| other | NASOPHARYNGITIS | Infections and infestations | Active Laser Photocoagulation and Sham Injection | 6 | 43 | 6 |
| other | HEADACHE | Nervous system disorders | Active Laser Photocoagulation and Ranibizumab | 5 | 85 | 5 |
| other | HEADACHE | Nervous system disorders | Active Laser Photocoagulation and Sham Injection | 1 | 43 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Laser Photocoagulation and Ranibizumab | ||
| Total, all-cause mortality | Active Laser Photocoagulation and Sham Injection | ||
| Total, other adverse events | Active Laser Photocoagulation and Ranibizumab | 32 | 85 |
| Total, other adverse events | Active Laser Photocoagulation and Sham Injection | 10 | 43 |
| Total, serious adverse events | Active Laser Photocoagulation and Ranibizumab | 14 | 85 |
| Total, serious adverse events | Active Laser Photocoagulation and Sham Injection | 5 | 43 |
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 |
|---|
| Active Laser Photocoagulation and Ranibizumab vs Active Laser Photocoagulation and Sham Injection: 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.
GET https://conductscience.org/api/trials/v1/NCT01131585
GET https://conductscience.org/api/trials/v1/NCT01131585/events?page=2