Phase 2
Completed N=42
An Extension to Study MD7108240
Macular Degeneration
Source: ClinicalTrials.gov NCT00733304 ↗
Enrolled (actual)
42
Serious AEs
7.1%
Results posted
Dec 2017
Primary outcomePrimary: Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period — 3.5; -0.4; 1.1; 1.8 Millimeters of mercury (mmHg)
Summary
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period |
3.5; -0.4; 1.1; 1.8; 1.6; -0.5 | — |
| PRIMARY Change From Baseline (Day 1) in Heart Rate Over Period |
-0.6; 2.4; 5.1; -0.3; 1.3; 5.0 | — |
| PRIMARY Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period |
0.6; -0.7; -1.1; 0.3; -1.0; -3.0 | — |
| PRIMARY Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period |
-2.8; -0.6; -0.1; 1.1; 1.8; -2.3 | — |
| PRIMARY Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period |
0.008; 0.008; -0.003; 0.007; 0.006; -0.010 | — |
| PRIMARY Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period |
0.12; 0.12; -0.05; 0.11; 0.08; -0.20 | — |
| PRIMARY Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period |
-0.1; -0.2; 0.3; 0.2; 0.0; 0.5 | — |
| PRIMARY Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period |
0.000; -0.020; -0.050; -0.006; -0.045; -0.100 | — |
| PRIMARY Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period |
0.1; -0.2; -1.1; 0.0; -0.6; -3.0 | — |
| PRIMARY Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period |
0.2; 0.7; 1.3; 0.1; 1.2; 1.1 | — |
| PRIMARY Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis |
0; 0; 1; 3; 2; 0 | — |
| PRIMARY Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) |
11; 9; 3; 2; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) |
2; 2; 0 | — |
| PRIMARY Number of Participants With Abnormal Pupil Examination of PCI |
2; 1; 1 | — |
| PRIMARY Number of Participants With Abnormal Conjunctival Examination of PCI |
0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Anterior Chamber Examination of PCI |
0; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Corneal Examination of PCI |
2; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale |
0; 1; 1 | — |
| PRIMARY Number of Participants With Abnormal Tear Films of PCI |
3; 1; 1 | — |
| PRIMARY Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function |
1; 0; 1 | — |
| PRIMARY Number of Participants With Abnormal (Dilated) Fundus Examination |
4; 1; 2 | — |
| SECONDARY Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 |
0.1; -5.3; -0.7; -5.6; -5.3; -3.0 | — |
| SECONDARY Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months |
8.3; 41.1; -18.0; 16.3; 18.3; 3.0 | — |
| SECONDARY Change in Neo-vascular Size and Lesion Size Over Period |
— | — |
| SECONDARY Number of Participants With Lesion Types Over Period |
16; 11; 3; 2; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who participated in Phase IIa study MD7108240 and who did not experience AMD disease progression requiring rescue therapy during pazopanib treatment or require discontinuation of pazopanib eye drops for safety reasons
- Best-corrected ETDRS visual acuity in the study eye of 23 letters (20/320 or 4/63) or better at screening.
- QTcB or QTcF 10%.
- Myocardial infarction or stroke within 6 months of screening.
- Active bleeding disorder.
- Major surgery within 1 month of screening.
- Hepatic impairment.
- Uncontrolled hypertension, based on criteria provided in the protocol. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met.
- Use of prohibited medications listed in the protocol within the restricted timeframe relative to the first dose of study medication.
- A condition or situation which, in the opinion of the investigator, may result in significant risk to the subject, confound the study results or interfere significantly with participation.
Data sourced from ClinicalTrials.gov (NCT00733304). 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.