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

NCT01134055 | Completed Phase 2 Results DMC

• 1 other identifier: 110852
• Study Type: interventional
• Target: 510
• Locations: 9 countries
• Sites: 77

Brief 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.

Conditions

Macular Degeneration

Keywords

ranibizumab; wet AMD; MD7110852; age related macular degeneration; age-related macular degeneration; macular degeneration; pazopanib

Outcome Measures

Primary Outcomes (1)

• 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

  BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.

  Day 1 and 52 weeks

Secondary Outcomes (17)

• Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks

  Up to 52 weeks

• Number of Participants With BCVA Over Time

  Up to Week 52

• Number of Participants Analyzed for Visual Acuity (VA) Response Over Time

  Week 52

• Change From Baseline in Center Point Thickness (CPT) Over Time

  Baseline and Week 52

• Number of Participants That Met Criteria for Re-injection

  Up to Week 52

Study Arms (7)

investigational arm 1

EXPERIMENTAL

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

Drug: pazopanib eye drops

investigational arm 2

EXPERIMENTAL

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

Drug: pazopanib eye drops

investigational arm 3

EXPERIMENTAL

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

Drug: pazopanib eye drops

investigational arm 4

EXPERIMENTAL

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

Drug: pazopanib eye drops

investigational arm 5

EXPERIMENTAL

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

Drug: pazopanib eye drops

placebo control arm

PLACEBO COMPARATOR

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

Drug: placebo

active open-label control arm

ACTIVE COMPARATOR

Ranibizumab intravitreal injection every 4 weeks

Biological: ranibizumab intravitreal injection

Interventions

pazopanib eye drops DRUG

A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.

investigational arm 1; investigational arm 2; investigational arm 3; investigational arm 4; investigational arm 5

placebo DRUG

placebo eye drops

placebo control arm

ranibizumab intravitreal injection BIOLOGICAL

Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A

active open-label control arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (77)

GSK Investigational Site

Peoria, Arizona, 85381, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85014, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85020, United States

Location

GSK Investigational Site

Tucson, Arizona, 85704, United States

Location

GSK Investigational Site

Tucson, Arizona, 85710, United States

Location

GSK Investigational Site

Irvine, California, 92697, United States

Location

GSK Investigational Site

Loma Linda, California, 92354, United States

Location

GSK Investigational Site

Poway, California, 92064, United States

Location

GSK Investigational Site

Santa Ana, California, 92705, United States

Location

GSK Investigational Site

Golden, Colorado, 80401, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Winter Haven, Florida, 33880, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Leawood, Kansas, 66211, United States

Location

GSK Investigational Site

Paducah, Kentucky, 42001, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21287, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02114, United States

Location

GSK Investigational Site

Royal Oak, Michigan, 48073, United States

Location

GSK Investigational Site

Traverse City, Michigan, 49686, United States

Location

GSK Investigational Site

New York, New York, 10003, United States

Location

GSK Investigational Site

Asheville, North Carolina, 28803, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28210, United States

Location

GSK Investigational Site

Beachwood, Ohio, 44122, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44130, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44195, United States

Location

GSK Investigational Site

Columbus, Ohio, 43212, United States

Location

GSK Investigational Site

Ashland, Oregon, 97520, United States

Location

GSK Investigational Site

Portland, Oregon, 97239, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Dallas, Texas, 75231, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Silverdale, Washington, 98383, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53705, United States

Location

GSK Investigational Site

Sydney, New South Wales, 2000, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2150, Australia

Location

GSK Investigational Site

Melbourne, Victoria, Australia

Location

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

GSK Investigational Site

Brussels, 1020, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 3N9, Canada

Location

GSK Investigational Site

Victoria, British Columbia, V8V 4X3, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

GSK Investigational Site

London, Ontario, N6A 4V2, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L4W 1W9, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

GSK Investigational Site

Aarhus, DK-8000, Denmark

Location

GSK Investigational Site

Glostrup Municipality, Denmark

Location

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

GSK Investigational Site

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80336, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

GSK Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10122, Italy

Location

GSK Investigational Site

Padua, Veneto, 35128, Italy

Location

GSK Investigational Site

Aichi, 460-0011, Japan

Location

GSK Investigational Site

Aichi, 462-0825, Japan

Location

GSK Investigational Site

Aichi, 466-8560, Japan

Location

GSK Investigational Site

Chiba, 279-0021, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Fukushima, 960-1295, Japan

Location

GSK Investigational Site

Hokkaido, 001-0016, Japan

Location

GSK Investigational Site

Hokkaido, 060-8604, Japan

Location

GSK Investigational Site

Kagawa, 761-0793, Japan

Location

GSK Investigational Site

Tokyo, 101-8309, Japan

Location

GSK Investigational Site

Linköping, SE-581 85, Sweden

Location

GSK Investigational Site

Örebro, SE-701 85, Sweden

Location

GSK Investigational Site

Stockholm, SE-112 82, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2017-12

Locations

DE (7); JP (10); BE (2); SE (4); AU (4); US (37); IT (5); DK (2); CA (6)