Trial · NCT01948830
Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
NCT01948830, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2016-12-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD. Trials, record NCT01948830. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01948830
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
- NCT number
- NCT01948830
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 650 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Age-related Macular Degeneration, Choroidal Neovascularization
- Interventions
- Ranibizumab 0.5mg, Ranibizumab 0.5mg
- First posted
- 2013-09-24
- Last updated
- 2017-04-17
- Other registries' IDs
- eudract:2013-002626-23
- Results first posted
- 2016-12-15
Source ClinicalTrials.gov
Registered outcomes14
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 | Baseline to month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement |
| Secondary | Number of Visits Scheduled | From Month1 to Month 11 | The number of visits scheduled according to the treat and extend regimen after treatment initiation |
| Secondary | Change in BCVA From Baseline to Month 12 | Baseline to Month 12 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters |
| Secondary | Average BCVA Change From Baseline to Month 12 | Baseline and every month for 12 months | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12 |
| Secondary | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Baseline and every month for 12 months | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline |
| Secondary | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Baseline and every month for 12 months | 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 increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline |
| Secondary | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Baseline and every month for 12 months | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. |
| Secondary | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Baseline and every month for 12 months | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome |
| Secondary | The Mean Number of Treatment Frequency | Month 12 | The number of injections received |
| Secondary | The Average Number of Days Between Injections | Month 12 | The average dosing interval was measured as the average number of days between injections |
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 in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Baseline to month 12 | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data. | Letters (EDTRS) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Visits Scheduled | From Month1 to Month 11 | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed. | Number of visits | MEAN |
| SECONDARY | Change in BCVA From Baseline to Month 12 | Baseline to Month 12 | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data. | Letters (EDTRS) | MEAN |
| SECONDARY | Average BCVA Change From Baseline to Month 12 | Baseline and every month for 12 months | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis. | Letters (EDTRS) | MEAN |
| SECONDARY | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Baseline and every month for 12 months | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit. | Letters (EDTRS) | MEAN |
| SECONDARY | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | Baseline and every month for 12 months | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Number of participants | NUMBER |
| SECONDARY | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Baseline and every month for 12 months | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Number of participants | NUMBER |
| SECONDARY | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Baseline and every month for 12 months | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Number of participants | NUMBER |
| SECONDARY | The Mean Number of Treatment Frequency | Month 12 | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization | Number of injections | MEAN |
| SECONDARY | The Average Number of Days Between Injections | Month 12 | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization | days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group292
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 | Group I Ranibizumab 0.5 mg TER | 6.2 | Standard Error 0.70 | Letters (EDTRS) | |
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Group II Ranibizumab 0.5 mg Monthly | 8.1 | Standard Error 0.70 | Letters (EDTRS) | |
| Number of Visits Scheduled | Group I Ranibizumab 0.5 mg TER | 8.9 | Standard Deviation 2.56 | Number of visits | |
| Number of Visits Scheduled | Group II Ranibizumab 0.5 mg Monthly | 11.2 | Standard Deviation 2.37 | Number of visits | |
| Change in BCVA From Baseline to Month 12 | Group I Ranibizumab 0.5 mg TER | 6.4 | Standard Deviation 14.11 | Letters (EDTRS) | |
| Change in BCVA From Baseline to Month 12 | Group II Ranibizumab 0.5 mg Monthly | 8.0 | Standard Deviation 11.61 | Letters (EDTRS) | |
| Average BCVA Change From Baseline to Month 12 | Group I Ranibizumab 0.5 mg TER | 6.3 | Standard Deviation 10.50 | Letters (EDTRS) | |
| Average BCVA Change From Baseline to Month 12 | Group II Ranibizumab 0.5 mg Monthly | 7.1 | Standard Deviation 9.41 | Letters (EDTRS) | |
| Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Group I Ranibizumab 0.5 mg TER | Month 1 (n=320, 322) | 4.6 | Standard Deviation 7.56 | Letters (EDTRS) |
| Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Group II Ranibizumab 0.5 mg Monthly | Month 1 (n=320, 322) | 4.2 | Standard Deviation 6.98 | Letters (EDTRS) |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I Ranibizumab 0.5 mg TER | 323 | |
| Overall Study | STARTED | Group II Ranibizumab 0.5 mg Monthly | 327 | |
| Overall Study | Safety Set | Group I Ranibizumab 0.5 mg TER | 323 | |
| Overall Study | Safety Set | Group II Ranibizumab 0.5 mg Monthly | 326 | |
| Overall Study | COMPLETED | Group I Ranibizumab 0.5 mg TER | 290 | |
| Overall Study | COMPLETED | Group II Ranibizumab 0.5 mg Monthly | 295 | |
| Overall Study | NOT COMPLETED | Group I Ranibizumab 0.5 mg TER | 33 | |
| Overall Study | NOT COMPLETED | Group II Ranibizumab 0.5 mg Monthly | 32 |
Source ClinicalTrials.gov
Adverse events296
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 | Age-related macular degeneration (Fellow eye) | Eye disorders | Group I Ranibizumab 0.5 mg TER | 9 | 323 | |
| other | Age-related macular degeneration (Fellow eye) | Eye disorders | Group II Ranibizumab 0.5 mg Monthly | 4 | 326 | |
| other | Blepharitis (Fellow eye) | Eye disorders | Group I Ranibizumab 0.5 mg TER | 6 | 323 | |
| other | Blepharitis (Fellow eye) | Eye disorders | Group II Ranibizumab 0.5 mg Monthly | 8 | 326 | |
| other | Blepharitis (Study eye) | Eye disorders | Group I Ranibizumab 0.5 mg TER | 5 | 323 | |
| other | Blepharitis (Study eye) | Eye disorders | Group II Ranibizumab 0.5 mg Monthly | 6 | 326 | |
| other | Cataract (Fellow eye) | Eye disorders | Group I Ranibizumab 0.5 mg TER | 7 | 323 | |
| other | Cataract (Fellow eye) | Eye disorders | Group II Ranibizumab 0.5 mg Monthly | 10 | 326 | |
| other | Cataract (Study eye) | Eye disorders | Group I Ranibizumab 0.5 mg TER | 7 | 323 | |
| other | Cataract (Study eye) | Eye disorders | Group II Ranibizumab 0.5 mg Monthly | 7 | 326 |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I Ranibizumab 0.5 mg TER | ||
| Total, all-cause mortality | Group II Ranibizumab 0.5 mg Monthly | ||
| Total, other adverse events | Group I Ranibizumab 0.5 mg TER | 164 | 323 |
| Total, other adverse events | Group II Ranibizumab 0.5 mg Monthly | 166 | 326 |
| Total, serious adverse events | Group I Ranibizumab 0.5 mg TER | 39 | 323 |
| Total, serious adverse events | Group II Ranibizumab 0.5 mg Monthly | 42 | 326 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Group I Ranibizumab 0.5 mg TER vs Group II Ranibizumab 0.5 mg Monthly: 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/NCT01948830
GET https://conductscience.org/api/trials/v1/NCT01948830/results?page=2