Trial · NCT00331864
SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
NCT00331864, Phase 3, Completed, Novartis; results first posted 2011-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration. Trials, record NCT00331864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00331864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
- NCT number
- NCT00331864
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 531 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Age Related Macular Degeneration, Choroidal Neovascularization
- Interventions
- Ranibizumab
- First posted
- 2006-05-31
- Last updated
- 2011-02-18
- Results first posted
- 2011-01-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye | Baseline through end of study (12 month treatment period) | Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period. |
| Primary | Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye | Baseline through end of study (12 month treatment period) | Grade 3 targeted AEs included: * 4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days * ≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection * sustained (\>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a \>20 mm Hg change in IOP persisting longer than 14 days * new retinal tear or detachment involving the macula * new vitreous hemorrhage \>2+ severity not resolving within 14 days * new or increase of previous retinal hemorrhage \>1 disc area in size and involving the fovea |
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Baseline and Month 3 | BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters. BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity. |
| Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Baseline and Month 12 | BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters. BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity. |
| Secondary | Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3 | Baseline and Month 3 | Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness). |
| Secondary | Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12 | Baseline and Month 12 | Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness). |
| Secondary | Time to the First Retreatment After Month 2 | Month 2 to Month 11 | Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment. Criteria for re-treatment: * a \>5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3) * a \>100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3) |
| Secondary | Total Number of Treatments | Baseline (Month 0) to Month 11 | Total number of treatments administered during the entire treatment period (Month 0 to 11). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye | Baseline through end of study (12 month treatment period) | For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Baseline and Month 3 | Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF. | Letters on the ETDRS-like testing charts | MEAN |
| SECONDARY | Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Baseline and Month 12 | Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF. | Letters on the ETDRS-like testing charts | MEAN |
| SECONDARY | Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3 | Baseline and Month 3 | Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF. | Micrometers | MEAN |
| SECONDARY | Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12 | Baseline and Month 12 | Non-ANCHOR patients: Analysis of Intent-to-Treat (ITT) population (all patients who received study drug at least once and had at least one post-baseline efficacy assessment) using last observation carried forward (LOCF). ANCHOR patients: Analysis of All Enrolled population (all enrolled patients) using LOCF. | Micrometers | MEAN |
| SECONDARY | Time to the First Retreatment After Month 2 | Month 2 to Month 11 | Intent-to-Treat (ITT) population patients: All patients who received study drug at least once and had at least one post-baseline efficacy assessment. The ANCHOR patients were not included in this analysis. | Months | MEDIAN |
| SECONDARY | Total Number of Treatments | Baseline (Month 0) to Month 11 | For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients. | Treatments | MEAN |
| PRIMARY | Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye | Baseline through end of study (12 month treatment period) | For Non-ANCHOR treatment group, the analysis population was the Safety population: All patients who had received at least one application of study drug and had at least one post-baseline safety assessment. For the ANCHOR treatment group, the analysis population was all enrolled patients. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye | Ranibizumab Non-ANCHOR | 48.5 | Percentage of Participants | ||
| Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye | Ranibizumab ANCHOR | 38.9 | Percentage of Participants | ||
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Ranibizumab Non-ANCHOR | Baseline | 56.2 | Standard Deviation 12.11 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Ranibizumab ANCHOR | Baseline | 47.2 | Standard Deviation 22.10 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Ranibizumab Non-ANCHOR | Change to Month 3 | 5.8 | Standard Deviation 11.12 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3 | Ranibizumab ANCHOR | Change to Month 3 | 1.9 | Standard Deviation 9.26 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Ranibizumab Non-ANCHOR | Baseline | 56.2 | Standard Deviation 12.11 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Ranibizumab ANCHOR | Baseline | 47.2 | Standard Deviation 22.10 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Ranibizumab Non-ANCHOR | Change to Month 12 | 3.6 | Standard Deviation 13.89 | Letters on the ETDRS-like testing charts |
| Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12 | Ranibizumab ANCHOR | Change to Month 12 | 1.6 | Standard Deviation 8.66 | Letters on the ETDRS-like testing charts |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab Non-ANCHOR | 513 | |
| Overall Study | STARTED | Ranibizumab ANCHOR | 18 | |
| Overall Study | COMPLETED | Ranibizumab Non-ANCHOR | 455 | |
| Overall Study | COMPLETED | Ranibizumab ANCHOR | 14 | |
| Overall Study | NOT COMPLETED | Ranibizumab Non-ANCHOR | 58 | |
| Overall Study | NOT COMPLETED | Ranibizumab ANCHOR | 4 |
Source ClinicalTrials.gov
Adverse events254
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 eye) | Eye disorders | Ranibizumab Non-ANCHOR | 16 | 513 | |
| other | Choroidal neovascularisation (Fellow eye) | Eye disorders | Ranibizumab ANCHOR | 2 | 18 | |
| other | Choroidal neovascularisation (Study eye) | Eye disorders | Ranibizumab Non-ANCHOR | 8 | 513 | |
| other | Choroidal neovascularisation (Study eye) | Eye disorders | Ranibizumab ANCHOR | 2 | 18 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Ranibizumab Non-ANCHOR | 28 | 513 | |
| other | Conjunctival haemorrhage (Study eye) | Eye disorders | Ranibizumab ANCHOR | 0 | 18 | |
| other | Retinal haemorrhage (Fellow eye) | Eye disorders | Ranibizumab Non-ANCHOR | 12 | 513 | |
| other | Retinal haemorrhage (Fellow eye) | Eye disorders | Ranibizumab ANCHOR | 2 | 18 | |
| other | Retinal haemorrhage (Study eye) | Eye disorders | Ranibizumab Non-ANCHOR | 35 | 513 | |
| other | Retinal haemorrhage (Study eye) | Eye disorders | Ranibizumab ANCHOR | 5 | 18 |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab Non-ANCHOR | ||
| Total, all-cause mortality | Ranibizumab ANCHOR | ||
| Total, other adverse events | Ranibizumab Non-ANCHOR | 199 | 513 |
| Total, other adverse events | Ranibizumab ANCHOR | 8 | 18 |
| Total, serious adverse events | Ranibizumab Non-ANCHOR | 80 | 513 |
| Total, serious adverse events | Ranibizumab ANCHOR | 4 | 18 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ranibizumab Non-ANCHOR vs Ranibizumab ANCHOR: 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/NCT00331864
GET https://conductscience.org/api/trials/v1/NCT00331864/results?page=2