Trial · NCT01362348
12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)
NCT01362348, Phase 2, Terminated, GlaxoSmithKline; results first posted 2017-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD). Trials, record NCT01362348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01362348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)
- NCT number
- NCT01362348
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Macular Degeneration
- Interventions
- pazopanib eye drops
- First posted
- 2011-05-30
- Last updated
- 2017-09-21
- Results first posted
- 2017-08-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29 | Baseline (Week 0) and Day 29 | CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29. |
| Primary | Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29 | Baseline (Day -3 to -1) and Day 29 | BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29. |
| Secondary | Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29. |
| Secondary | Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29. |
| Secondary | Change From Baseline in BCVA Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29. |
| Secondary | Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29 | Baseline (Day -3 to -1) and Day 29 | CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29. |
| Secondary | Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP | Day 29 | Fundus photography involves capturing of images of the center of the very back inner wall of the eye - the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29. |
| Secondary | Number of Participants Who Received Rescue Medication | Up to follow-up (Day 102) | At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by \>50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up. |
| Secondary | Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs | Until Follow-up (Day 102) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. |
| Secondary | Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination | Up to Follow-up (Day 102) | A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29 | Baseline (Week 0) and Day 29 | The Intent-to-treat (ITT) Population comprised of any participant who received at least one dose of study medication. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis. | Microns | MEAN |
| PRIMARY | Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29 | Baseline (Day -3 to -1) and Day 29 | ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis. | Count of letters | MEAN |
| SECONDARY | Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis. | Microns | MEAN |
| SECONDARY | Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis. | Microns | MEAN |
| SECONDARY | Change From Baseline in BCVA Over Time | Baseline (Week -3 to -1) Up to Follow-up (Day 102) | ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis. | Letters | MEAN |
| SECONDARY | Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29 | Baseline (Day -3 to -1) and Day 29 | ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis. | millimeter square | MEAN |
| SECONDARY | Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP | Day 29 | ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received Rescue Medication | Up to follow-up (Day 102) | Safety Population comprised of any participant who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs | Until Follow-up (Day 102) | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination | Up to Follow-up (Day 102) | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group77
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 Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29 | Pazopanib 10 mg/mL QID | 37.91 | Standard Deviation 89.692 | Microns | |
| Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29 | Pazopanib 10 mg/mL QID | 0.07 | Standard Deviation 9.973 | Count of letters | |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 1 | -3.97 | Standard Deviation 93.420 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 2 | -6.39 | Standard Deviation 93.420 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 3 | 15.15 | Standard Deviation 86.646 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 4 | 31.72 | Standard Deviation 88.289 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 6 | 51.22 | Standard Deviation 84.679 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 8 | 15.48 | Standard Deviation 82.304 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Week 12 | -1.57 | Standard Deviation 75.216 | Microns |
| Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time | Pazopanib 10 mg/mL QID | CRLT at Follow-up | -8.42 | Standard Deviation 91.346 | Microns |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pazopanib 10 mg/mL QID | 19 | |
| Overall Study | COMPLETED | Pazopanib 10 mg/mL QID | 5 | |
| Overall Study | NOT COMPLETED | Pazopanib 10 mg/mL QID | 14 |
Source ClinicalTrials.gov
Adverse events22
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 | Pazopanib 10 mg/mL QID | 2 | 19 | |
| other | Macular oedema | Eye disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Ocular Hypertension | Eye disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Retinal haemorrhage | Eye disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Vitreous floaters | Eye disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Instillation site pain | General disorders | Pazopanib 10 mg/mL QID | 3 | 19 | |
| other | Nausea | Gastrointestinal disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Oesophageal obstruction | Gastrointestinal disorders | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Tooth infection | Infections and infestations | Pazopanib 10 mg/mL QID | 1 | 19 | |
| other | Urinary tract infection | Infections and infestations | Pazopanib 10 mg/mL QID | 1 | 19 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pazopanib 10 mg/mL QID | 0 | 19 |
| Total, other adverse events | Pazopanib 10 mg/mL QID | 17 | 19 |
| Total, serious adverse events | Pazopanib 10 mg/mL QID | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24896137 | 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.
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/NCT01362348
GET https://conductscience.org/api/trials/v1/NCT01362348/results?page=2