Trial · NCT01217944
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT01217944, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia. Trials, record NCT01217944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01217944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
- NCT number
- NCT01217944
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 277 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Pathological Myopia
- Interventions
- Ranibizumab, Verteporfin PDT, Sham Ranibizumab, Sham verteporfin PDT
- First posted
- 2010-10-08
- Last updated
- 2014-02-10
- Other registries' IDs
- eudract:2010-021662-30
- Results first posted
- 2013-10-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline, Month 1 through Month 3 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3. |
| Secondary | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline and Month 6 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet. |
| Secondary | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline and Month 1 through Month 12 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12 |
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 | 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 percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3. |
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Months 6 and 12 | 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 percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12. |
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 | 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3. |
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Months 6 and 12 | 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12. |
| Secondary | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline, Month 3, Month 6 and Month 12 | Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators. |
| Secondary | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline and Month 12 | CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators. |
| Secondary | Number of Ranibizumab Injections Received Prior to Month 3 | Day 1 and prior to month 3 | In order to describe exposure to the study drug the number of ejections was evaluated |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline, Month 1 through Month 3 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Letters | MEAN |
| SECONDARY | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline and Month 6 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Letters | MEAN |
| SECONDARY | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline and Month 1 through Month 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Letters | MEAN |
| SECONDARY | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Months 6 and 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Months 6 and 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline, Month 3, Month 6 and Month 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Microns | MEAN |
| SECONDARY | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline and Month 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Percentage of Patients | NUMBER |
| SECONDARY | Number of Ranibizumab Injections Received Prior to Month 3 | Day 1 and prior to month 3 | The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab \[sham\] and/or vPDT \[sham\]) and had at least one post-baseline safety assessment | injections | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Baseline | 55.4 | Standard Deviation 13.43 | Letters |
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | 0.5mg Ranibizumab Driven by Disease Activity | Baseline | 55.8 | Standard Deviation 12.59 | Letters |
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Verteporfin PDT | Baseline | 54.7 | Standard Deviation 13.84 | Letters |
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Month 1 to month 3 | 66.0 | Standard Deviation 12.98 | Letters |
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | 0.5mg Ranibizumab Driven by Disease Activity | Average Month 1 to month 3 | 66.4 | Standard Deviation 12.28 | Letters |
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Verteporfin PDT | Average Month 1 to month 3 | 56.9 | Standard Deviation 14.49 | Letters |
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Baseline | 55.4 | Standard Deviation 13.43 | Letters |
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | 0.5mg Ranibizumab Driven by Disease Activity | Baseline | 55.8 | Standard Deviation 12.59 | Letters |
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Verteporfin PDT | Baseline | 54.7 | Standard Deviation 13.84 | Letters |
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average month 1 to month 6 | 69.2 | Standard Deviation 12.44 | Letters |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 106 | |
| Overall Study | STARTED | 0.5mg Ranibizumab Driven by Disease Activity | 116 | |
| Overall Study | STARTED | Verteporfin PDT | 55 | |
| Overall Study | Completed 3 Months | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 105 | |
| Overall Study | Completed 3 Months | 0.5mg Ranibizumab Driven by Disease Activity | 116 | |
| Overall Study | Completed 3 Months | Verteporfin PDT | 55 | |
| Overall Study | Completed 6 Months | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 103 | |
| Overall Study | Completed 6 Months | 0.5mg Ranibizumab Driven by Disease Activity | 116 | |
| Overall Study | Completed 6 Months | Verteporfin PDT | 55 | |
| Overall Study | COMPLETED | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 100 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events164
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 | Tinnitus | Ear and labyrinth disorders | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 0 | 106 | |
| other | Tinnitus | Ear and labyrinth disorders | 0.5mg Ranibizumab Driven by Disease Activity | 2 | 118 | |
| other | Tinnitus | Ear and labyrinth disorders | Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3 | 0 | 38 | |
| other | Tinnitus | Ear and labyrinth disorders | Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3 | 1 | 15 | |
| other | Blindness (Study eye) | Eye disorders | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 0 | 106 | |
| other | Blindness (Study eye) | Eye disorders | 0.5mg Ranibizumab Driven by Disease Activity | 0 | 118 | |
| other | Blindness (Study eye) | Eye disorders | Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3 | 1 | 38 | |
| other | Blindness (Study eye) | Eye disorders | Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3 | 1 | 15 | |
| other | Cataract (Study eye) | Eye disorders | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 1 | 106 | |
| other | Cataract (Study eye) | Eye disorders | 0.5mg Ranibizumab Driven by Disease Activity | 2 | 118 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5 mg Ranibizumab Driven by Stabilization Criteria | ||
| Total, all-cause mortality | 0.5mg Ranibizumab Driven by Disease Activity | ||
| Total, all-cause mortality | Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3 | ||
| Total, all-cause mortality | Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3 | ||
| Total, other adverse events | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 46 | 106 |
| Total, other adverse events | 0.5mg Ranibizumab Driven by Disease Activity | 47 | 118 |
| Total, other adverse events | Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3 | 17 | 38 |
| Total, other adverse events | Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3 | 8 | 15 |
| Total, serious adverse events | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 7 | 106 |
| Total, serious adverse events | 0.5mg Ranibizumab Driven by Disease Activity | 6 | 118 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 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.
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