Trial · NCT01292798
Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab
NCT01292798, Phase 1, Phase 2, Completed, California Retina Consultants; results first posted 2016-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab. Trials, record NCT01292798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01292798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab
- NCT number
- NCT01292798
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- California Retina Consultants
- Conditions
- Diabetic Macular Edema
- Interventions
- Ranibizumab
- First posted
- 2011-02-10
- Last updated
- 2016-04-22
- Results first posted
- 2016-04-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline | baseline and 6 months | To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months. |
| Secondary | Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline | baseline and 6 months | To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months . |
| Secondary | Qualitative Assessment of Diabetic Macular Edema (DME) | Baeline and 6 months | To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline | baseline and 6 months | letters | MEAN | |
| SECONDARY | Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline | baseline and 6 months | microns | MEAN | |
| SECONDARY | Qualitative Assessment of Diabetic Macular Edema (DME) | Baeline and 6 months | At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | Baseline | 58.8 | Standard Deviation 9.7 | letters |
| Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | 6 months | 67.6 | Standard Deviation 9.3 | letters |
| Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | Change from Baseline to 6 months | 8.8 | Standard Deviation 9.3 | letters |
| Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | Baseline | 500.6 | Standard Deviation 129.1 | microns |
| Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | 6 months | 335.2 | Standard Deviation 91.5 | microns |
| Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline | 0.5mg and 2.0mgRanibizumab | Change from Baseline to 6 months | -165.4 | Standard Deviation 91.5 | microns |
| Qualitative Assessment of Diabetic Macular Edema (DME) | 0.5mg and 2.0mgRanibizumab | complete resolution | 42 | percentage of participants | |
| Qualitative Assessment of Diabetic Macular Edema (DME) | 0.5mg and 2.0mgRanibizumab | partial/no resolution | 58 | percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2.0 mg Ranibizumab | 43 | |
| Overall Study | Persistent DME After 3 Months | 2.0 mg Ranibizumab | 29 | |
| Overall Study | COMPLETED | 2.0 mg Ranibizumab | 43 | |
| Overall Study | NOT COMPLETED | 2.0 mg Ranibizumab | 0 |
Source ClinicalTrials.gov
Adverse events1
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 |
|---|---|---|---|---|---|---|
| serious | Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | 2.0 mg Ranibizumab | 1 | 43 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2.0 mg Ranibizumab | ||
| Total, other adverse events | 2.0 mg Ranibizumab | 0 | 43 |
| Total, serious adverse events | 2.0 mg Ranibizumab | 1 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25633882 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01292798
GET https://conductscience.org/api/trials/v1/NCT01292798/registered