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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01134055
• Date of registration: 27/05/2010
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
• Scientific title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
• Date of first enrolment: June 2010
• Target sample size: 510
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01134055
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Sweden, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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-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.



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Macular Degeneration

Intervention(s)

Drug: placebo

Biological: ranibizumab intravitreal injection

Drug: pazopanib eye drops

Primary Outcome(s)

Change from baseline in best-corrected visual acuity [Time Frame: Baseline and 52 weeks]

Secondary Outcome(s)

Number of ranibizumab intravitreal injections [Time Frame: 52 weeks]

Secondary ID(s)

110852

Source(s) of Monetary Support

Please refer to primary and secondary sponsors