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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Endothelial Growth Factors; Ophthalmic Solutions; Ranibizumab; Tetrahydrozoline

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.