Trial · NCT02034006
A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
NCT02034006, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-02-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia. Trials, record NCT02034006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02034006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.
- NCT number
- NCT02034006
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Choroidal Neovascularization Secondary to Pathologic Myopia
- Interventions
- Ranibizumab
- First posted
- 2014-01-13
- Last updated
- 2019-02-18
- Other registries' IDs
- eudract:2013-003334-33
- Results first posted
- 2019-02-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening, Month 2, Month 6 | Presence of active leakage on fluorescein angiography (FAG) was assessed at screening (14 to 3 days before baseline visit), month 2 and month 6. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of active leakage (Yes/No). For retreated patients, the presence/absence of active leakage was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening, Month 2, Month 6, Month 12 | Presence of macular edema from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of macular edema (Yes/No). For retreated patients, the presence/absence of macular edema was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening, Month 2, Month 6, Month 12 | Presence of cysts from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of cysts (Yes/No). For retreated patients, the presence/absence of cysts was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening, Month 2, Month 6, Month 12 | Presence of Intra-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of Intra-retinal fluid (Yes/No). For retreated patients, the presence/absence of Intra-retinal fluid was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Primary | Change in Central Subfield Thickness (CSFT) | Screening, Month 2, Month 6, Month 12 | Central subfield thickness (CSFT) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSFT versus previous visit. For retreated patients, the change in CSFT was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Primary | Change in Central Subfield Volume (CSV) | Screening, Month 2, Month 6, Month 12 | Central subfield volume (CSV) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSV versus previous visit. For retreated patients, the change in CSV was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening, Month 2, Month 6, Month 12 | Presence of sub-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. The regression model for sub-retinal fluid was not valid because "Yes" was reported in almost all subjects causing a quasi-complete separation of data points. \*NE = Not evaluable |
| Primary | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Presence of clinically significant abnormalities was assessed at baseline, month 1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of clinically significant abnormalities (Yes/No). For retreated patients, the presence/absence of clinically significant abnormalities was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Primary | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Improvement in BCVA \< 5 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 5 letters (Yes/No) which was reported as Gain \>= 5 letters versus Gain \< 5 letters. For retreated patients, Gain \>= 5 letters and Gain \< 5 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Primary | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Improvement in BCVA \< 10 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 10 letters (Yes/No) which was reported as Gain \>= 10 letters versus Gain \< 10 letters. For retreated patients, Gain \>= 10 letters and Gain \< 10 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening, Month 2, Month 6 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent fluorescein angiography at that time point. | Patients | NUMBER |
| SECONDARY | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye | Baseline, Month 6, Month 12 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab. The study eyes of the patients belonging to the FAS were analyzed. | letters | MEAN |
| SECONDARY | Mean Number of Ranibizumab Injection | Baseline to Month 12 | Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab | injections | MEAN |
| SECONDARY | Time to Re-treatment | Baseline to Month 12 | Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab | Months | MEAN |
| SECONDARY | Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Baseline to Month 12 | Safety Population: all subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment. | Patients | NUMBER |
| SECONDARY | Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Baseline, Month 2, Month 12 | Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab with data at both timepoints. | units on a scale | MEAN |
| PRIMARY | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening, Month 2, Month 6, Month 12 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point. | Patients | NUMBER |
| PRIMARY | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening, Month 2, Month 6, Month 12 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point. | Patients | NUMBER |
| PRIMARY | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening, Month 2, Month 6, Month 12 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point. | Patients | NUMBER |
| PRIMARY | Change in Central Subfield Thickness (CSFT) | Screening, Month 2, Month 6, Month 12 | Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point and previous visit. | micromilimeter(um) | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group248
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Treated Once | Screening: Active leakage, No | 3 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Re-treated Once | Screening: Active leakage, No | 0 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Treated Once | Screening: Active leakage, Yes | 61 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Re-treated Once | Screening: Active leakage, Yes | 121 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Treated Once | Screening: Active leakage, NE | 0 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Re-treated Once | Screening: Active leakage, NE | 2 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Treated Once | Screening: Active leakage, Missing | 0 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Re-treated Once | Screening: Active leakage, Missing | 1 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Treated Once | Month 2: Active leakage, No | 58 | Patients | |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Ranibizumab: Re-treated Once | Month 2: Active leakage, No | 61 | Patients |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab | 200 | |
| Overall Study | Once Treated Patients | Ranibizumab | 70 | |
| Overall Study | Re-treated Patients | Ranibizumab | 130 | |
| Overall Study | COMPLETED | Ranibizumab | 186 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 14 |
Source ClinicalTrials.gov
Adverse events13
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 (Non-study Eye) | Eye disorders | Ranibizumab | 3 | 200 | |
| other | Choroidal neovascularisation (Study Eye) | Eye disorders | Ranibizumab | 7 | 200 | |
| other | Conjunctival haemorrhage (Study Eye) | Eye disorders | Ranibizumab | 4 | 200 | |
| other | Conjunctival hyperaemia (Both Eyes) | Eye disorders | Ranibizumab | 5 | 200 | |
| other | Ocular hypertension (Both Eyes) | Eye disorders | Ranibizumab | 4 | 200 | |
| other | Influenza | Infections and infestations | Ranibizumab | 7 | 200 | |
| serious | Atrioventricular block | Cardiac disorders | Ranibizumab | 1 | 200 | |
| serious | Cardiac arrest | Cardiac disorders | Ranibizumab | 1 | 200 | |
| serious | Cholecystitis acute | Hepatobiliary disorders | Ranibizumab | 1 | 200 | |
| serious | Klebsiella sepsis | Infections and infestations | Ranibizumab | 1 | 200 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab | ||
| Total, other adverse events | Ranibizumab | 26 | 200 |
| Total, serious adverse events | Ranibizumab | 7 | 200 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30680452 | DERIVED |
Source PubMed
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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