Trial · NCT01396083
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
NCT01396083, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO). Trials, record NCT01396083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01396083
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
- NCT number
- NCT01396083
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 243 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Visual Impairment, Macular Edema, Central Retinal Vein Occlusion
- Interventions
- Ranibizumab, Dexamethasone implant and sham injections
- First posted
- 2011-07-18
- Last updated
- 2016-09-27
- Other registries' IDs
- eudract:2011-001020-38
- Results first posted
- 2015-02-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | Baseline, month 6 | the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity |
| Secondary | Mean BCVA Change at Month 6 | Baseline, month 6 | The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors |
| Secondary | Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Baseline, 6 month | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline |
| Secondary | Time to Achieve a Significant Improvement ≥ 15 Letters | Baseline, month 6 | The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts |
| Secondary | Change Over Time in BCVA | Baseline, month 6 | The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors |
| Secondary | Change Over Time of the Central Retinal Thickness (CRT) | Baseline, month 6 | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation |
| Secondary | Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires | Baseline, month 6 | The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function |
| Secondary | Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires | Baseline, month 6 | SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health |
| Secondary | Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires | Baseline, month 6 | The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state. |
| Secondary | Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline | Baseline, month 6 | The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Letters | MEAN |
| SECONDARY | Mean BCVA Change at Month 6 | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Letters | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Baseline, 6 month | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Participants | NUMBER |
| SECONDARY | Time to Achieve a Significant Improvement ≥ 15 Letters | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Time to event (Days) | MEDIAN |
| SECONDARY | Change Over Time in BCVA | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | letters | LEAST_SQUARES_MEAN |
| SECONDARY | Change Over Time of the Central Retinal Thickness (CRT) | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | µm | MEAN |
| SECONDARY | Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned | Score on a scale | MEAN |
| SECONDARY | Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis. | Units on a scale | MEAN |
| SECONDARY | Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires | Baseline, month 6 | The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis | Units on a scale | MEAN |
| SECONDARY | Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline | Baseline, month 6 | The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | Ranibizumab | 14.6 | Standard Deviation 11.8 | Letters | |
| Mean Average BCVA Change From Month 1 Through Month 6 to Baseline | Dexamethasone | 4.8 | Standard Deviation 16.2 | Letters | |
| Mean BCVA Change at Month 6 | Ranibizumab | 14.78 | 95% Confidence Interval 11.24 to 18.32 | Letters | |
| Mean BCVA Change at Month 6 | Dexamethasone | -3.17 | 95% Confidence Interval -6.80 to 0.46 | Letters | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Ranibizumab | Gain≥15 letters | 73 | Participants | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Dexamethasone | Gain≥15 letters | 22 | Participants | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Ranibizumab | Loss of ≥15 letters | 1 | Participants | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Dexamethasone | Loss of ≥15 letters | 31 | Participants | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Ranibizumab | Gain ≥10 letters | 89 | Participants | |
| Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters | Dexamethasone | Gain ≥10 letters | 38 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab | 124 | |
| Overall Study | STARTED | Dexamethasone | 119 | |
| Overall Study | COMPLETED | Ranibizumab | 113 | |
| Overall Study | COMPLETED | Dexamethasone | 72 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 11 | |
| Overall Study | NOT COMPLETED | Dexamethasone | 47 |
Source ClinicalTrials.gov
Adverse events158
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 | ABNORMAL SENSATION IN EYE (Study eye) | Eye disorders | Ranibizumab | 6 | 124 | |
| other | ABNORMAL SENSATION IN EYE (Study eye) | Eye disorders | Dexamethasone | 8 | 119 | |
| other | CONJUNCTIVAL HAEMORRHAGE (Study eye) | Eye disorders | Ranibizumab | 16 | 124 | |
| other | CONJUNCTIVAL HAEMORRHAGE (Study eye) | Eye disorders | Dexamethasone | 13 | 119 | |
| other | DRY EYE (Fellow eye) | Eye disorders | Ranibizumab | 4 | 124 | |
| other | DRY EYE (Fellow eye) | Eye disorders | Dexamethasone | 1 | 119 | |
| other | DRY EYE (Study eye) | Eye disorders | Ranibizumab | 4 | 124 | |
| other | DRY EYE (Study eye) | Eye disorders | Dexamethasone | 4 | 119 | |
| other | EYE IRRITATION (Study eye) | Eye disorders | Ranibizumab | 4 | 124 | |
| other | EYE IRRITATION (Study eye) | Eye disorders | Dexamethasone | 3 | 119 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab | ||
| Total, all-cause mortality | Dexamethasone | ||
| Total, other adverse events | Ranibizumab | 77 | 124 |
| Total, other adverse events | Dexamethasone | 99 | 119 |
| Total, serious adverse events | Ranibizumab | 10 | 124 |
| Total, serious adverse events | Dexamethasone | 16 | 119 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ranibizumab vs Dexamethasone: Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline | Trial comparisons |
| Ranibizumab vs Dexamethasone: serious adverse events | 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/NCT01396083
GET https://conductscience.org/api/trials/v1/NCT01396083/results?page=2