Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Drug: placebo; Biological: ranibizumab intravitreal injection; Drug: pazopanib eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134055

110852

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 510 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 7 patient groups, including a placebo group

investigational arm 1

Experimental group

Description:

5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Treatment:

Drug: pazopanib eye drops

investigational arm 2

Experimental group

Description:

5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Treatment:

Drug: pazopanib eye drops

investigational arm 3

Experimental group

Description:

10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection

Treatment:

Drug: pazopanib eye drops

investigational arm 4

Experimental group

Description:

10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection

Treatment:

Drug: pazopanib eye drops

investigational arm 5

Experimental group

Description:

10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection

Treatment:

Drug: pazopanib eye drops

placebo control arm

Placebo Comparator group

Description:

Placebo eye drops QID with allowance for as-needed ranibizumab injection

Treatment:

Drug: placebo

active open-label control arm

Active Comparator group

Description:

Ranibizumab intravitreal injection every 4 weeks

Treatment:

Biological: ranibizumab intravitreal injection