Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 1/10/2018 |
Start Date: | June 1, 2010 |
End Date: | October 1, 2012 |
MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
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.
regimens of pazopanib eye drops for the treatment of neovascular age-related macular
degeneration.
MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and
safety of pazopanib eye drops for the treatment of neovascular age related macular
degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular
endothelial growth factor) injection therapy. Eye drop regimens are double-masked with
placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection
if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.
safety of pazopanib eye drops for the treatment of neovascular age related macular
degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular
endothelial growth factor) injection therapy. Eye drop regimens are double-masked with
placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection
if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.
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.
We found this trial at
35
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