Phase 2
Completed N=70
To Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Macular Degeneration
Source: ClinicalTrials.gov NCT00612456 ↗
Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Sep 2017
Primary outcomePrimary: Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29 — 7.5; 10.0; 31.2; 7.5 Microns — p=0.6241
Summary
This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Central Retinal/Lesion Thickness (CRLT) as Measured by the Carl Zeiss Meditec Stratus Optical Coherence Tomography (OCT) Scanner at Day 29 |
7.5; 10.0; 31.2; 7.5; 3.0; 9.1 | 0.6241 |
| SECONDARY Number of Participants With Complete Ophthalmic Examination Values of Potential Clinical Concern |
0; 0; 0 | — |
| SECONDARY Number of Participants With Vital Sign Data for Systolic Blood Pressure and Diastolic Blood Pressure and Heart Rate of Potential Clinical Concern |
1; 4; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings |
11; 11; 6; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern |
4; 1; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Urinalysis Data by Dipstick Analysis |
1; 1; 2; 0; 1; 0 | — |
| SECONDARY Number of Participants With Ocular Adverse Events, Non-ocular Adverse Events, Serious Ocular Adverse Events and Serious Non-ocular Adverse Events |
10; 5; 2; 2; 0; 1 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) [Number of Letter Read on Standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) Charts at Day 29 |
4.3; 0.8; 0.0; 4.8; 1.7; -0.1 | 0.0015 sig |
| SECONDARY Number of Participants With Change in Retinal Morphology (Cystoid Spaces, Subretinal Fluid and Retinal Pigment Epithelial Detachment) as Determined by OCT |
9; 10; 5; 1; 2; 1 | — |
| SECONDARY Number of Participants With Change in Characteristics (Fibrosis, Atrophy, Blood) as Measured by Fundus Photography (FP) |
14; 14; 7; 7; 1; 1 | — |
| SECONDARY Change From Baseline in Neovascular Size, Total Lesion Size, Fluorescein Angiography (FA) Leakage Area of Measurement, FA Blood Area of Measurement as Measured by FA at Day 29 |
0.6; 0.44; 0.7; 0.2; 1.5; 0.7 | 0.0534 |
| SECONDARY Plasma Pharmacokinetic Parameter Maximum Observed Concentration (Cmax) |
56.104; 21.142; 17.680 | — |
| SECONDARY Plasma Pharmacokinetic Parameter Time of Occurrence of Cmax (Tmax) |
3.000; 2.970; 3.000 | — |
| SECONDARY Plasma Pharmacokinetic Parameter Area Under Concentration Time-curve From Time Zero to 6 Hours (AUC [0-6)] |
312.17998; 124.57714; 96.13500 | — |
Eligibility Criteria
Inclusion Criteria
- Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required:
- central subfield thickness > 300 microns on investigator-determined OCT (inclusive of subretinal fluid)
- active subfoveal leakage as determined by investigator-determined fluorescein angiography
- minimally classic or occult with no classic CNV lesion
- lesion size no greater than 12 disc areas
- CNV > 50% of lesion area
- 10 mg prednisone or equivalent/day) within 14 days of first dose.
- An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit
- Medical history or condition:
- Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%.
- Myocardial infarction or stroke within 12 months of screening.
- Active bleeding disorder.
- Major surgery within 1 month of screening.
- Hepatic impairment.
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT00612456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.