Trial · NCT01780935
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
NCT01780935, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration. Trials, record NCT01780935. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01780935
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration
- NCT number
- NCT01780935
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 671 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Ranibizumab
- First posted
- 2013-01-31
- Last updated
- 2017-08-14
- Other registries' IDs
- eudract:2011-004959-39
- Results first posted
- 2017-01-02
- Limitations and caveats
Use of optical coherence tomography guided therapy in the treatment of neovascular age related macular degeneration became standard of care by HA \& Ophth. community during the time this trial was conducted.Novartis terminated this trial.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | up to Month 12 | Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye. |
| Secondary | Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | up to Month 12 | Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye. |
| Secondary | Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24 | Baseline to Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24 | Baseline to Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24 | Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye | Month 3 to Month 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye | Baseline to Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time | Baseline to Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Dry Retina in the Study Eye on OCT at Month 12 and 24 | Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
| Secondary | Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24 | Baseline to Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | up to Month 12 | Full Analysis Set (FAS) includes all randomized patients | Letters correctly read | MEAN |
| SECONDARY | Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | up to Month 12 | Full Analysis Set (FAS) includes all randomized patients | letters correctly read | MEAN |
| SECONDARY | Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24 | Baseline to Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24 | Baseline to Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24 | Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye | Month 3 to Month 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye | Baseline to Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time | Baseline to Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Dry Retina in the Study Eye on OCT at Month 12 and 24 | Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | ||
| SECONDARY | Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24 | Baseline to Month 12 and 24 | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | RBZ 0.5 mg: VA Only (Group I) | 0.1 | Standard Deviation 6.79 | Letters correctly read | |
| Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | RBZ 0.5 mg: VA and/or OCT (Group II) | 1.0 | Standard Deviation 7.25 | Letters correctly read | |
| Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | RBZ 0.5 mg: VA Only (Group I) | 6.7 | Standard Deviation 13.48 | letters correctly read | |
| Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | RBZ 0.5 mg: VA and/or OCT (Group II) | 8.3 | Standard Deviation 13.53 | letters correctly read |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RBZ 0.5 mg: VA Only (Group I) | 335 | |
| Overall Study | STARTED | RBZ 0.5 mg: VA and/or OCT (Group II) | 336 | |
| Overall Study | Safety Set | RBZ 0.5 mg: VA Only (Group I) | 334 | |
| Overall Study | Safety Set | RBZ 0.5 mg: VA and/or OCT (Group II) | 336 | |
| Overall Study | COMPLETED | RBZ 0.5 mg: VA Only (Group I) | 0 | |
| Overall Study | COMPLETED | RBZ 0.5 mg: VA and/or OCT (Group II) | 0 | |
| Overall Study | NOT COMPLETED | RBZ 0.5 mg: VA Only (Group I) | 335 | |
| Overall Study | NOT COMPLETED | RBZ 0.5 mg: VA and/or OCT (Group II) | 336 |
Source ClinicalTrials.gov
Adverse events218
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 (Fellow untreated eye) | Eye disorders | RBZ 0.5 mg: VA Only (Group I) | 5 | 334 | |
| other | Choroidal neovascularisation (Fellow untreated eye) | Eye disorders | RBZ 0.5 mg: VA and/or OCT (Group II) | 7 | 336 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | RBZ 0.5 mg: VA Only (Group I) | 19 | 334 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | RBZ 0.5 mg: VA and/or OCT (Group II) | 10 | 336 | |
| other | Dry eye (Fellow untreated eye) | Eye disorders | RBZ 0.5 mg: VA Only (Group I) | 7 | 334 | |
| other | Dry eye (Fellow untreated eye) | Eye disorders | RBZ 0.5 mg: VA and/or OCT (Group II) | 4 | 336 | |
| other | Dry eye (Study eye) | Eye disorders | RBZ 0.5 mg: VA Only (Group I) | 10 | 334 | |
| other | Dry eye (Study eye) | Eye disorders | RBZ 0.5 mg: VA and/or OCT (Group II) | 7 | 336 | |
| other | Eye pain (Study eye) | Eye disorders | RBZ 0.5 mg: VA Only (Group I) | 10 | 334 | |
| other | Eye pain (Study eye) | Eye disorders | RBZ 0.5 mg: VA and/or OCT (Group II) | 9 | 336 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RBZ 0.5 mg: VA Only (Group I) | ||
| Total, all-cause mortality | RBZ 0.5 mg: VA and/or OCT (Group II) | ||
| Total, other adverse events | RBZ 0.5 mg: VA Only (Group I) | 111 | 334 |
| Total, other adverse events | RBZ 0.5 mg: VA and/or OCT (Group II) | 105 | 336 |
| Total, serious adverse events | RBZ 0.5 mg: VA Only (Group I) | 30 | 334 |
| Total, serious adverse events | RBZ 0.5 mg: VA and/or OCT (Group II) | 45 | 336 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31918685 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| RBZ 0.5 mg: VA Only (Group I) vs RBZ 0.5 mg: VA and/or OCT (Group II): 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/NCT01780935
GET https://conductscience.org/api/trials/v1/NCT01780935/events?page=2