Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration

NCT ID: NCT02222207

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

Part A (Phase IIa):

Primary objectives:

The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.

Secondary objectives:

The study will also evaluate the safety and tolerability of the regorafenib eye drops.

Part B (Phase IIb):

Primary objectives:

The study part B is designed to investigate:

• how often the regorafenib eye drops need to be given per day
• whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.

Secondary objectives:

The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Regorafenib [A]

Part A: Patients will receive Regorafenib eye drops

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Regorafenib [B1]

Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Regorafenib [B2]

Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Regorafenib [B3]

Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Regorafenib [B4]

Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Regorafenib [B5]

Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Regorafenib [B6]

Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks

Group Type: EXPERIMENTAL

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Intervention Type: DRUG

Subjects receive Regorafenib as eye drops

Sham IVT

Intervention Type: PROCEDURE

Sham injections

Ranibizumab

Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Subjects receive Ranibizumab as intravitreal injection

Placebo

Intervention Type: DRUG

Placebo eye drops

Interventions

Regorafenib, ophthalmic oily suspension (BAY73-4506)

Subjects receive Regorafenib as eye drops

Intervention Type: DRUG

Sham IVT

Sham injections

Intervention Type: PROCEDURE

Ranibizumab

Subjects receive Ranibizumab as intravitreal injection

Intervention Type: DRUG

Placebo

Placebo eye drops

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and able to understand the informed consent form (ICF)
• Men and women ≥ 50 years of age
• Active primary subfoveal CNV (Choroidal neovascularization) lesions secondary to AMD (Age-related macular degeneration), including juxtafoveal lesions that affect the fovea as evidenced by FA (Fluorescein angiography) in the study eye and reviewed by the central reading center
• The area of CNV must occupy at least 50% of total lesion in the study eye, as determined by FA review at the central reading center
• Evidence of intraretinal and/or subretinal fluid on OCT (Optical coherence tomography)
• Early Treatment Diabetic Retinopathy Study BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye
• Willing, committed, and able to return for all clinic visits and complete all study related procedures
• Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies since signing of the ICF until one month after the EOS (end of study) visit. The definition of adequate contraception will be based on the judgment of the investigator.

Exclusion Criteria

• Concurrent disease in the study eye, other than AMD (e.g., corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could compromise visual acuity, likely require medical or surgical intervention during the study period, would limit the potential to gain or lose vision during study treatment, or could otherwise confound interpretation of the results
• Total lesion size (including neovascularization, scar, blood) > 12 disc areas (30.5 mm2) as assessed by FA
• Only one functional eye, even if that eye is otherwise eligible for the study
• Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
• Prior treatment with any systemic anti-VEGF (Vascular endothelial growth factor) agent
• Use of systemic or ocular treatment with an investigational drug within 12 weeks prior to start of study treatment
• Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration (e.g. contact lens)
• Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
• Participation in an investigational study within 30 days prior to start of study treatment that involved treatment with any drug (excluding vitamins and minerals) or device
• Lactating women and women of child-bearing potential with either a positive pregnancy test result or no pregnancy test at screening are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Tucson, Arizona, United States

Arcadia, California, United States

Beverly Hills, California, United States

Campbell, California, United States

Costa Mesa, California, United States

Laguna Hills, California, United States

Mountain View, California, United States

Santa Ana, California, United States

Golden, Colorado, United States

Boynton Beach, Florida, United States

Fort Myers, Florida, United States

Miami, Florida, United States

Plantation, Florida, United States

Sarasota, Florida, United States

Stuart, Florida, United States

Winter Haven, Florida, United States

Decatur, Georgia, United States

New Albany, Indiana, United States

Leawood, Kansas, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Eunice, Louisiana, United States

Boston, Massachusetts, United States

Grand Rapids, Michigan, United States

Florissant, Missouri, United States

Teaneck, New Jersey, United States

Asheville, North Carolina, United States

West Mifflin, Pennsylvania, United States

Greenville, South Carolina, United States

Rapid City, South Dakota, United States

Austin, Texas, United States

Houston, Texas, United States

McAllen, Texas, United States

San Antonio, Texas, United States

Temple, Texas, United States

The Woodlands, Texas, United States

Charlottesville, Virginia, United States

Strathfield, New South Wales, Australia

Sydney, New South Wales, Australia

Westmead, New South Wales, Australia

Nedlands, Western Australia, Australia

Parramatta, , Australia

Vienna, Vienna, Austria

Vienna, , Austria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

London, Ontario, Canada

Mississauga, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Osorno, Los Lagos Region, Chile

Metropolitana, Santiago Metropolitan, Chile

Santiago, Santiago Metropolitan, Chile

Vitacura, Santiago Metropolitan, Chile

Bogotá, Bogota D.C., Colombia

Hradec Králové, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Paris, Cedex 12, France

Boredaux, , France

Lyon, , France

Tübingen, Baden-Wurttemberg, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Bonn, North Rhine-Westphalia, Germany

Cologne, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Berlin, State of Berlin, Germany

Hong Kong, , Hong Kong

Kowloon, , Hong Kong

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Afula, , Israel

Beersheba, , Israel

Haifa, , Israel

Haifa, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Udine, Friuli Venezia Giulia, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Florence, Tuscany, Italy

Padua, Veneto, Italy

Ancona, , Italy

Bologna, , Italy

Milan, , Italy

Sassari, , Italy

Inba-gun, Chiba, Japan

Fukuoka, Fukuoka, Japan

Miyako-gun, Fukuoka, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Himeji, Hyōgo, Japan

Yamato, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Iga, Mie-ken, Japan

Nagasaki, Nagasaki, Japan

Nara, Nara, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Chōfu, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Taito-ku, Tokyo, Japan

Bratislava, , Slovakia

Ružomberok, , Slovakia

Trenčín, , Slovakia

Žilina, , Slovakia

Žilina, , Slovakia

Seongnam-si, Gyeonggido, South Korea

Busan, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Albacete, Albacete, Spain

Barcelona, Barcelona, Spain

L'Hospitalet de Llobregat, Barcelona, Spain

San Cugat Del Vallès, Barcelona, Spain

Seville, Sevilla, Spain

Seville, Sevilla, Spain

Valencia, Valencia, Spain

Valladolid, Valladolid, Spain

Barakaldo, Vizcaya, Spain

Valencia, , Spain

Bern, Canton of Bern, Switzerland

Zurich, Canton of Zurich, Switzerland

Lausanne, , Switzerland

Countries

United States; Australia; Austria; Canada; Chile; Colombia; Czechia; France; Germany; Hong Kong; Hungary; Israel; Italy; Japan; Slovakia; South Korea; Spain; Switzerland

Other Identifiers

2012-003763-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15984

Identifier Type: -

Identifier Source: org_study_id