Trial · NCT00891735
A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
NCT00891735, Phase 3, Completed, Genentech, Inc.; results first posted 2013-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR). Trials, record NCT00891735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00891735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
- NCT number
- NCT00891735
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,097 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Age-related Macular Degeneration
- Interventions
- Ranibizumab
- First posted
- 2009-05-01
- Last updated
- 2013-01-18
- Results first posted
- 2013-01-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Baseline to Month 12 | BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement. |
| Secondary | Number of Ranibizumab Injections up to But Not Including Month 12 | Baseline to Month 12 | |
| Secondary | Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12 | Baseline to Month 12 | BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. |
| Secondary | Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12 | Month 12 | VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart. |
| Secondary | Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12 | Month 12 | The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness \< 270 µm. |
| Secondary | Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT). |
| Secondary | Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT). |
| Secondary | Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12 | Baseline to Month 12 | The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm\^2. |
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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Baseline to Month 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | Letters | MEAN |
| SECONDARY | Number of Ranibizumab Injections up to But Not Including Month 12 | Baseline to Month 12 | All treated patients. Observed data were used with no imputation. | Injections | MEAN |
| SECONDARY | Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12 | Baseline to Month 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12 | Month 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12 | Month 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | Percentage of patients | NUMBER |
| SECONDARY | Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | µm | MEAN |
| SECONDARY | Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | mm^3 | MEAN |
| SECONDARY | Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12 | Baseline to Month 12 | Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method. | Disc area units | MEAN |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Ranibizumab 0.5 mg Monthly | 10.1 | Standard Deviation 13.3 | Letters | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Ranibizumab 2.0 mg Monthly | 9.2 | Standard Deviation 14.6 | Letters | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 8.2 | Standard Deviation 13.3 | Letters | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 8.6 | Standard Deviation 13.8 | Letters | |
| Number of Ranibizumab Injections up to But Not Including Month 12 | Ranibizumab 0.5 mg Monthly | 11.3 | Standard Deviation 1.8 | Injections | |
| Number of Ranibizumab Injections up to But Not Including Month 12 | Ranibizumab 2.0 mg Monthly | 11.2 | Standard Deviation 2.1 | Injections | |
| Number of Ranibizumab Injections up to But Not Including Month 12 | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 7.7 | Standard Deviation 2.7 | Injections | |
| Number of Ranibizumab Injections up to But Not Including Month 12 | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 6.9 | Standard Deviation 2.4 | Injections | |
| Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12 | Ranibizumab 0.5 mg Monthly | 34.5 | 95% Confidence Interval 28.9 to 40.2 | Percentage of patients | |
| Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12 | Ranibizumab 2.0 mg Monthly | 36.1 | 95% Confidence Interval 30.4 to 41.8 | Percentage of patients |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab 0.5 mg Monthly | 275 | |
| Overall Study | STARTED | Ranibizumab 2.0 mg Monthly | 274 | |
| Overall Study | STARTED | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 275 | |
| Overall Study | STARTED | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 273 | |
| Overall Study | COMPLETED | Ranibizumab 0.5 mg Monthly | 258 | |
| Overall Study | COMPLETED | Ranibizumab 2.0 mg Monthly | 258 | |
| Overall Study | COMPLETED | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 263 | |
| Overall Study | COMPLETED | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 258 | |
| Overall Study | NOT COMPLETED | Ranibizumab 0.5 mg Monthly | 17 | |
| Overall Study | NOT COMPLETED | Ranibizumab 2.0 mg Monthly | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events844
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 | Age-related macular degeneration | Eye disorders | Ranibizumab 0.5 mg Monthly | 8 | 274 | |
| other | Age-related macular degeneration | Eye disorders | Ranibizumab 2.0 mg Monthly | 15 | 274 | |
| other | Age-related macular degeneration | Eye disorders | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 15 | 275 | |
| other | Age-related macular degeneration | Eye disorders | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 13 | 272 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 0.5 mg Monthly | 63 | 274 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 2.0 mg Monthly | 51 | 274 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 48 | 275 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 41 | 272 | |
| other | Detachment of retinal pigment epithelium | Eye disorders | Ranibizumab 0.5 mg Monthly | 4 | 274 | |
| other | Detachment of retinal pigment epithelium | Eye disorders | Ranibizumab 2.0 mg Monthly | 4 | 274 |
1 to 10 of 844Source ClinicalTrials.gov
See all 844 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab 0.5 mg Monthly | ||
| Total, all-cause mortality | Ranibizumab 2.0 mg Monthly | ||
| Total, all-cause mortality | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | ||
| Total, all-cause mortality | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | ||
| Total, other adverse events | Ranibizumab 0.5 mg Monthly | 240 | 274 |
| Total, other adverse events | Ranibizumab 2.0 mg Monthly | 243 | 274 |
| Total, other adverse events | Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN]) | 250 | 275 |
| Total, other adverse events | Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN]) | 239 | 272 |
| Total, serious adverse events | Ranibizumab 0.5 mg Monthly | 66 | 274 |
| Total, serious adverse events | Ranibizumab 2.0 mg Monthly | 54 | 274 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers21
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.
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/NCT00891735
GET https://conductscience.org/api/trials/v1/NCT00891735/results?page=2