Trial · NCT01134055
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
NCT01134055, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration. Trials, record NCT01134055. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01134055
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
- NCT number
- NCT01134055
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 510 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Macular Degeneration
- Interventions
- pazopanib eye drops, placebo, ranibizumab intravitreal injection
- First posted
- 2010-05-31
- Last updated
- 2018-01-08
- Results first posted
- 2018-01-08
Source ClinicalTrials.gov
Registered outcomes18
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) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Day 1 and 52 weeks | BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. |
| Secondary | Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks | Up to 52 weeks | The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. Injection rate over 52 weeks was computed by taking the number of injections received divided by the number of visits for the participant. Likewise for 28 weeks it was estimated as the number of post baseline injections received divided by the number of post baseline visits at or before the week 28 visit. |
| Secondary | Number of Participants With BCVA Over Time | Up to Week 52 | BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. |
| Secondary | Number of Participants Analyzed for Visual Acuity (VA) Response Over Time | Week 52 | VA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters.The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. This outcome measure contains the number of participants who were analyzed for VA response. |
| Secondary | Change From Baseline in Center Point Thickness (CPT) Over Time | Baseline and Week 52 | CPT was the inner limiting membrane to the beginning of the retinal pigment epithelium (RPE) inclusive of SR fluid. The outer boundary included the outer segment of the photoreceptors and not included the RPE. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. In amendment 3, inclusion criterion number 5 was revised to remove the required quantitative OCT component. OCT examination was used to supplement FA findings and provided qualitative (presence of SR and/or IR fluid) and quantitative (a CPT that is at least 250 microns) evidence of an active subfoveal lesion. Hence data for pre and post amendment have been provided separately. |
| Secondary | Number of Participants That Met Criteria for Re-injection | Up to Week 52 | The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. |
| Secondary | Change From Baseline in the Area of Choroidal Neovascularisation (CNV) | Day 1, Week 28 and Week 52 | Choroidal neovascularisation is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. |
| Secondary | Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis) | Day 1, Week 28 and Week 52 | CNV is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. |
| Secondary | Change From Baseline in the Area of Fluorescein Leakage | Day 1, Week 28 and Week 52 | Fluorescein angiograms was performed at the Screening, Week 12, Week 28, and Week 52 Visits. All images, including any that were performed at the investigator's medical discretion, were transferred to the FPRC. Fluorescein was injected intravenously according to usual clinic procedures. Dose response was also examined under different aspects of re-injection, such as time to first injection, the percentage of participants that required an injection by Week 28, as well as the estimation of the probability of reinjection. FA assessments of area of fluorescein leakage, CNV area and area of CNV lesion complex were also examined for dose differentiation. |
| Secondary | Change in Area of Serous Sensory Retinal Detachment (SSRD) | Day 1, Week 28 and Week 52 | This is an Optical coherence tomography (OCT) parameter used to manually measure thickness along any scan. OCT was performed at week 28 and week 52. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Day 1 and 52 weeks | Intent to Treat Population - It consisted of all randomized participants, according to the treatment groups assigned by randomization (i.e., planned rather than the actual treatment regimen), who received at least one dose of study medication. Only participants with data available at the indicated time points were analyzed. | Letters | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks | Up to 52 weeks | Intent to Treat Population | Percentage of re-injections | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With BCVA Over Time | Up to Week 52 | Intent to Treat Population. Only participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Analyzed for Visual Acuity (VA) Response Over Time | Week 52 | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Center Point Thickness (CPT) Over Time | Baseline and Week 52 | Intent to Treat Population | Microns | MEAN |
| SECONDARY | Number of Participants That Met Criteria for Re-injection | Up to Week 52 | Intent to Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Area of Choroidal Neovascularisation (CNV) | Day 1, Week 28 and Week 52 | Intent to Treat Population | Millimeter (mm)^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis) | Day 1, Week 28 and Week 52 | Intent to Treat Population | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Area of Fluorescein Leakage | Day 1, Week 28 and Week 52 | Intent to Treat Population | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Area of Serous Sensory Retinal Detachment (SSRD) | Day 1, Week 28 and Week 52 | Intent to Treat Population | mm^2 | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group2,234
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) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Placebo Control Arm QID | 0.22 | Standard Error 1.006 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Pazopanib Eye Drops 5 mg/mL TID | 1.15 | Standard Error 1.004 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Pazopanib Eye Drops 5 mg/mL QID | 1.81 | Standard Error 0.975 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Pazopanib Eye Drops 10 mg/mL BID | 0.76 | Standard Error 0.995 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Pazopanib Eye Drops 10 mg/mL TID | 0.28 | Standard Error 0.992 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Pazopanib Eye Drops 10 mg/mL QID | 0.62 | Standard Error 1.007 | Letters | |
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52 | Ranibizumab Injections Active Open-label Control Arm | 1.42 | Standard Error 1.020 | Letters | |
| Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks | Placebo Control Arm QID | Injection Rate at 28 Weeks | 65.04 | Standard Error 3.418 | Percentage of re-injections |
| Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks | Pazopanib Eye Drops 5 mg/mL TID | Injection Rate at 28 Weeks | 55.03 | Standard Error 3.441 | Percentage of re-injections |
| Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks | Pazopanib Eye Drops 5 mg/mL QID | Injection Rate at 28 Weeks | 67.92 | Standard Error 3.395 | Percentage of re-injections |
1 to 10 of 2,234Source ClinicalTrials.gov
See all 2,234 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Control Arm QID | 73 | |
| Overall Study | STARTED | Pazopanib Eye Drops 5 mg/mL TID | 72 | |
| Overall Study | STARTED | Pazopanib Eye Drops 5 mg/mL QID | 74 | |
| Overall Study | STARTED | Pazopanib Eye Drops 10 mg/mL BID | 73 | |
| Overall Study | STARTED | Pazopanib Eye Drops 10 mg/mL TID | 73 | |
| Overall Study | STARTED | Pazopanib Eye Drops 10 mg/mL QID | 72 | |
| Overall Study | STARTED | Ranibizumab Injections Active Open-label Control Arm | 73 | |
| Overall Study | COMPLETED | Placebo Control Arm QID | 65 | |
| Overall Study | COMPLETED | Pazopanib Eye Drops 5 mg/mL TID | 66 | |
| Overall Study | COMPLETED | Pazopanib Eye Drops 5 mg/mL QID | 71 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events812
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 | Nasopharyngitis | Infections and infestations | Placebo Control Arm QID | 11 | 73 | |
| other | Nasopharyngitis | Infections and infestations | Pazopanib Eye Drops 5 mg/mL TID | 5 | 72 | |
| other | Nasopharyngitis | Infections and infestations | Pazopanib Eye Drops 5 mg/mL QID | 6 | 74 | |
| other | Nasopharyngitis | Infections and infestations | Pazopanib Eye Drops 10 mg/mL BID | 17 | 73 | |
| other | Nasopharyngitis | Infections and infestations | Pazopanib Eye Drops 10 mg/mL TID | 5 | 73 | |
| other | Nasopharyngitis | Infections and infestations | Pazopanib Eye Drops 10 mg/mL QID | 13 | 72 | |
| other | Nasopharyngitis | Infections and infestations | Ranibizumab Injections Active Open-label Control Arm | 5 | 73 | |
| other | Hypertension | Vascular disorders | Placebo Control Arm QID | 3 | 73 | |
| other | Hypertension | Vascular disorders | Pazopanib Eye Drops 5 mg/mL TID | 4 | 72 | |
| other | Hypertension | Vascular disorders | Pazopanib Eye Drops 5 mg/mL QID | 5 | 74 |
1 to 10 of 812Source ClinicalTrials.gov
See all 812 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Control Arm QID | 2 | 73 |
| Total, all-cause mortality | Pazopanib Eye Drops 5 mg/mL TID | 1 | 72 |
| Total, all-cause mortality | Pazopanib Eye Drops 5 mg/mL QID | 1 | 74 |
| Total, all-cause mortality | Pazopanib Eye Drops 10 mg/mL BID | 0 | 73 |
| Total, all-cause mortality | Pazopanib Eye Drops 10 mg/mL TID | 3 | 73 |
| Total, all-cause mortality | Pazopanib Eye Drops 10 mg/mL QID | 0 | 72 |
| Total, all-cause mortality | Ranibizumab Injections Active Open-label Control Arm | 1 | 73 |
| Total, other adverse events | Placebo Control Arm QID | 52 | 73 |
| Total, other adverse events | Pazopanib Eye Drops 5 mg/mL TID | 34 | 72 |
| Total, other adverse events | Pazopanib Eye Drops 5 mg/mL QID | 47 | 74 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 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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