Trial · NCT01840410
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
NCT01840410, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization. Trials, record NCT01840410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01840410
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
- NCT number
- NCT01840410
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 183 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Choroidal Neovascularization (CNV)
- Interventions
- Ranibizumab, Sham control
- First posted
- 2013-04-25
- Last updated
- 2016-08-26
- Other registries' IDs
- eudract:2012-005417-38
- Results first posted
- 2016-08-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Baseline, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in BCVA in Study Eye up to Month 2 | Baseline, Month 1, Month 2 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement. |
| Secondary | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | CSFV was assessed OCT. A negative change from baseline indicates improvement. |
| Secondary | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | The presence of intra-retinal fluid was assessed by OCT. |
| Secondary | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | Presence of subretinal fluid in study eye compared to baseline |
| Secondary | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Month 2, Month 6, Month 12 | The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA). |
| Secondary | Average Change From Baseline in BCVA | Baseline (BL), Month 1 through Month 6, Month 1 through Month 12 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement. |
| Secondary | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Secondary | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Month 6, Month 12 | VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Baseline, Month 2 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed. | letters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in BCVA in Study Eye up to Month 2 | Baseline, Month 1, Month 2 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | letters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | micrometer (um) | MEAN |
| SECONDARY | Change From Baseline in Central Subfield Volume (CSFV) in Study Eye | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | microliter (ul) | MEAN |
| SECONDARY | Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline | Baseline, Month 2, Month 6, Month 12 | The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis. | Participants | NUMBER |
| SECONDARY | Number of Participants With Presence of Active Chorioretinal Leakage | Baseline, Month 2, Month 6, Month 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Participants | NUMBER |
| SECONDARY | Average Change From Baseline in BCVA | Baseline (BL), Month 1 through Month 6, Month 1 through Month 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | letters | MEAN |
| SECONDARY | Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters | Month 2, Month 6, Month 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Participants | NUMBER |
| SECONDARY | Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss | Month 2, Month 6, Month 12 | The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group225
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Ranibizumab | 9.5 | Standard Error 0.95 | letters | |
| Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 | Sham Control | -0.4 | Standard Error 1.16 | letters | |
| Change From Baseline in BCVA in Study Eye up to Month 2 | Ranibizumab | Month 1 | 7.1 | Standard Error 0.75 | letters |
| Change From Baseline in BCVA in Study Eye up to Month 2 | Sham Control | Month 1 | 0.1 | Standard Error 1.08 | letters |
| Change From Baseline in BCVA in Study Eye up to Month 2 | Ranibizumab | Month 2 | 9.5 | Standard Error 0.91 | letters |
| Change From Baseline in BCVA in Study Eye up to Month 2 | Sham Control | Month 2 | -0.4 | Standard Error 1.31 | letters |
| Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Ranibizumab | Month 1 (n=115,56) | -74.4 | Standard Deviation 81.25 | micrometer (um) |
| Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Sham Control | Month 1 (n=115,56) | 3.3 | Standard Deviation 89.43 | micrometer (um) |
| Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Ranibizumab | Month 2 (n=114,54) | -76.4 | Standard Deviation 108.24 | micrometer (um) |
| Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye | Sham Control | Month 2 (n=114,54) | 1.9 | Standard Deviation 119.44 | micrometer (um) |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 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 | 119 | |
| Overall Study | STARTED | Sham Control | 59 | |
| Overall Study | Safety Set | Ranibizumab | 119 | |
| Overall Study | Safety Set | Sham Control | 59 | |
| Overall Study | Full Analysis Set | Ranibizumab | 119 | |
| Overall Study | Full Analysis Set | Sham Control | 59 | |
| Overall Study | COMPLETED | Ranibizumab | 112 | |
| Overall Study | COMPLETED | Sham Control | 55 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 7 | |
| Overall Study | NOT COMPLETED | Sham Control | 4 |
Source ClinicalTrials.gov
Adverse events96
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 | Choroidal neovascularisation (Study eye) | Eye disorders | Ranibizumab | 3 | 119 | |
| other | Choroidal neovascularisation (Study eye) | Eye disorders | Sham With Ranibizumab | 0 | 52 | |
| other | Choroidal neovascularisation (Study eye) | Eye disorders | Sham Without Ranibizumab | 1 | 7 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Ranibizumab | 7 | 119 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Sham With Ranibizumab | 6 | 52 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Sham Without Ranibizumab | 0 | 7 | |
| other | Eye inflammation (Study eye) | Eye disorders | Ranibizumab | 0 | 119 | |
| other | Eye inflammation (Study eye) | Eye disorders | Sham With Ranibizumab | 0 | 52 | |
| other | Eye inflammation (Study eye) | Eye disorders | Sham Without Ranibizumab | 1 | 7 | |
| other | Foreign body sensation in eyes (Study eye) | Eye disorders | Ranibizumab | 1 | 119 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab | ||
| Total, all-cause mortality | Sham With Ranibizumab | ||
| Total, all-cause mortality | Sham Without Ranibizumab | ||
| Total, other adverse events | Ranibizumab | 42 | 119 |
| Total, other adverse events | Sham With Ranibizumab | 19 | 52 |
| Total, other adverse events | Sham Without Ranibizumab | 4 | 7 |
| Total, serious adverse events | Ranibizumab | 9 | 119 |
| Total, serious adverse events | Sham With Ranibizumab | 4 | 52 |
| Total, serious adverse events | Sham Without Ranibizumab | 0 | 7 |
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 vs Sham Control: Number of Participants With Requirement for Rescue Treatment at Month 1 |
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/NCT01840410
GET https://conductscience.org/api/trials/v1/NCT01840410/results?page=2