Phase 2
N=510
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01134055 ↗Enrolled (actual)
510
Serious AEs
13.9%
Results posted
Jan 2018
Primary outcome: 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 — 0.22; 1.15; 1.81; 0.76 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pazopanib eye drops (Drug); placebo (Drug); ranibizumab intravitreal injection (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0.22; 1.15; 1.81; 0.76; 0.28; 0.62 | — |
| SECONDARY Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks |
65.04; 55.03; 67.92; 66.11; 61.61; 59.42 | 0.1974 |
| SECONDARY Number of Participants With BCVA Over Time |
49; 49; 57; 57; 58; 57 | — |
| SECONDARY Number of Participants Analyzed for Visual Acuity (VA) Response Over Time |
25; 19; 20; 18; 21; 23 | — |
| SECONDARY Change From Baseline in Center Point Thickness (CPT) Over Time |
10.0; 12.3; 3.4; -27.6; 16.6; 9.7 | — |
| SECONDARY Number of Participants That Met Criteria for Re-injection |
49; 33; 54; 48; 45; 44 | — |
| SECONDARY Change From Baseline in the Area of Choroidal Neovascularisation (CNV) |
0.10; 0.16; 0.09; 0.06; -0.05; 0.13 | — |
| SECONDARY Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis) |
0.18; 0.32; 0.23; 0.12; 0.00; 0.13 | — |
| SECONDARY Change From Baseline in the Area of Fluorescein Leakage |
-0.33; -0.27; -0.32; -0.40; -0.61; -0.33 | — |
| SECONDARY Change in Area of Serous Sensory Retinal Detachment (SSRD) |
-0.30; -0.28; -0.14; -0.55; -0.64; -0.46 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
11; 10; 12; 11; 10; 11 | — |
| SECONDARY Summary of Potentially Clinically Important Findings for Ophthalmic Examinations |
4; 2; 4; 2; 1; 2 | — |
| SECONDARY Summary of Intraocular Pressure Exam Findings |
0; 0; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With Vital Sign Values Outside of Clinical Concern Range |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Summary of Abnormal Electrocardiogram (ECG) Findings |
10; 11; 13; 10; 13; 17 | — |
| SECONDARY Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Data of Clinical Concern for Urine Protein |
7; 3; 5; 6; 2; 1 | — |
| SECONDARY Plasma Concentrations of Pazopanib |
80.20; 103.38; 93.82; 114.33; 175.89; 81.94 | — |
Summary
The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.
Eligibility Criteria
Inclusion Criteria
- Men and women aged ≥50 years.
- Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.
- Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and in need of re-treatment.
- Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320 Snellen equivalents or better).
Exclusion Criteria
- Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation.
- Prior failure to anti-VEGF intravitreal injection therapy.
- Recent ocular investigational drug/device for non-CNV condition.
- Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if ≥3 months and has posterior chamber intraocular lens.
- Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear.
- CNV in either eye due to other causes.
- Clinical evidence of diabetic retinopathy or diabetic macular edema.
- Recent myocardial infarction or cerebrovascular accident.
- Uncontrolled hypertension in spite of antihypertensive medications.
Data sourced from ClinicalTrials.gov (NCT01134055). 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.