Trial · NCT01922102
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT01922102, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia. Trials, record NCT01922102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01922102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
- NCT number
- NCT01922102
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 457 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)
- Interventions
- Ranibizumab 0.5mg, Ranibizumab 0.5 mg, Verteporfin PDT
- First posted
- 2013-08-14
- Last updated
- 2019-06-24
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | From Baseline to Month 3 | Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. |
| Secondary | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | From Baseline to Month 6 | Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6. |
| Secondary | The Average Change in BCVA Score From Baseline to Month 1 Through Month 12 | From Baseline to Month 12 | Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 12 |
| Secondary | Mean Change From Baseline in Visual Acuity Over Time | Change from baseline at months 3, 6, and 12 | Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. |
| Secondary | Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye | From Baseline to Month 12 | ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF. |
| Secondary | Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT) | Baseline, Month 3, Month 6, and Month 12 | Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT. |
| Secondary | Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12 | From Baseline until Month 12 | CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing. |
| Secondary | NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12 | Change from baseline at month 3, 6 and 12 | The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning. |
| Secondary | Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups | From Baseline to Month 12 | To assess treatment pattern with ranibizumab |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | From Baseline to Month 3 | Full Analysis Set (FAS): consisted of all patients to whom study treatment were assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization. | ETDRS letters | MEAN |
| SECONDARY | Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | From Baseline to Month 6 | Full Analysis Set (FAS): Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.~FAS, modified last observation carried forward (LOCF), for comparison between ranibizumab treatment groups.): consisted of all patients to whom study treatment were assigned. | ETDRS letters | MEAN |
| SECONDARY | The Average Change in BCVA Score From Baseline to Month 1 Through Month 12 | From Baseline to Month 12 | FAS, modified LOCF for comparison between ranibizumab treatment groups. | ETDRS letters | MEAN |
| SECONDARY | Mean Change From Baseline in Visual Acuity Over Time | Change from baseline at months 3, 6, and 12 | FAS | ETDRS letters | MEAN |
| SECONDARY | Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye | From Baseline to Month 12 | FAS | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT) | Baseline, Month 3, Month 6, and Month 12 | micrometer | MEAN | |
| SECONDARY | Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12 | From Baseline until Month 12 | FAS | Participants | NUMBER |
| SECONDARY | NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12 | Change from baseline at month 3, 6 and 12 | FAS | Composite score | MEAN |
| SECONDARY | Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups | From Baseline to Month 12 | Safety Set: all patients who received at least one application of study treatment \& had at least one post-Baseline safety assessment. Patients were analyzed according to treatment received. One patient randomized to vPDT Group III received one ranibizumab injection prior to Month 3; this patient was analyzed under Group II in Safety Set | Injections | MEAN |
Source ClinicalTrials.gov
Results by group101
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group I | Baseline | 53.7 | Standard Deviation 12.65 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group II | Baseline | 54.2 | Standard Deviation 13.01 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group III | Baseline | 52.6 | Standard Deviation 12.29 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group I | Average Month 1 to Month 3 | 63.1 | Standard Deviation 12.80 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group II | Average Month 1 to Month 3 | 63.9 | Standard Deviation 13.28 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3 | Group III | Average Month 1 to Month 3 | 57.1 | Standard Deviation 13.21 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | Group I | Baseline | 53.7 | Standard Deviation 12.65 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | Group II | Baseline | 54.2 | Standard Deviation 13.01 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | Group III | Baseline | 52.6 | Standard Deviation 12.29 | ETDRS letters |
| Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6 | Group I | Average Month 1 to Month 6 | 64.1 | Standard Deviation 12.77 | ETDRS letters |
1 to 10 of 101Source ClinicalTrials.gov
See all 101 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I | 182 | |
| Overall Study | STARTED | Group II | 184 | |
| Overall Study | STARTED | Group III | 91 | |
| Overall Study | COMPLETED | Group I | 173 | |
| Overall Study | COMPLETED | Group II | 175 | |
| Overall Study | COMPLETED | Group III | 83 | |
| Overall Study | NOT COMPLETED | Group I | 9 | |
| Overall Study | NOT COMPLETED | Group II | 9 | |
| Overall Study | NOT COMPLETED | Group III | 8 |
Source ClinicalTrials.gov
Adverse events756
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 | Thrombocytopenia | Blood and lymphatic system disorders | Group I | 0 | 182 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group II | 0 | 185 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group III With 0.5mg Ranibizumab | 1 | 75 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Group III Without 0.5mg Ranibizumab | 1 | 14 | |
| other | Palpitations | Cardiac disorders | Group I | 1 | 182 | |
| other | Palpitations | Cardiac disorders | Group II | 0 | 185 | |
| other | Palpitations | Cardiac disorders | Group III With 0.5mg Ranibizumab | 0 | 75 | |
| other | Palpitations | Cardiac disorders | Group III Without 0.5mg Ranibizumab | 1 | 14 | |
| other | Ventricular extrasystoles | Cardiac disorders | Group I | 0 | 182 | |
| other | Ventricular extrasystoles | Cardiac disorders | Group II | 0 | 185 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I | ||
| Total, all-cause mortality | Group II | ||
| Total, all-cause mortality | Group III With 0.5mg Ranibizumab | ||
| Total, all-cause mortality | Group III Without 0.5mg Ranibizumab | ||
| Total, other adverse events | Group I | 102 | 182 |
| Total, other adverse events | Group II | 116 | 185 |
| Total, other adverse events | Group III With 0.5mg Ranibizumab | 50 | 75 |
| Total, other adverse events | Group III Without 0.5mg Ranibizumab | 8 | 14 |
| Total, serious adverse events | Group I | 7 | 182 |
| Total, serious adverse events | Group II | 15 | 185 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT01922102
GET https://conductscience.org/api/trials/v1/NCT01922102/results?page=2