Trial Condition(s):

Macular degeneration

Regorafenib eye drops: Investigation of efficacy and safety in neovascular age related macular degeneration (DREAM)

Bayer Identifier:

15984

ClinicalTrials.gov Identifier:

NCT02222207

EudraCT Number:

2012-003763-22

Terminated/Withdrawn

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
52
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Regorafenib, ophthalmic oily suspension (BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Praha 4, Czech Republic, 140 00

Status
Completed
 
Locations

Investigative Site

Bern, Switzerland, 3010

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Terminated
 
Locations

Investigative Site

Wien, Austria, 1130

Status
Terminated
 
Locations

Investigative Site

Hamburg, Germany, 20251

Status
Completed
 
Locations

Investigative Site

Bonn, Germany, 53105

Status
Terminated
 
Locations

Investigative Site

Münster, Germany, 48145

Status
Terminated
 
Locations

Investigative Site

München, Germany, 81675

Status
Terminated
 
Locations

Investigative Site

Berlin, Germany, 12203

Status
Completed
 
Locations

Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Investigative Site

Rehovot, Israel, 7610001

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 6423906

Status
Terminated
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Terminated
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3436212

Status
Completed
 
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Terminated
 
Locations

Investigative Site

Zerifin, Israel, 6093000

Status
Completed
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Terminated
 
Locations

Investigative Site

Sevilla, Spain, 41013

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46015

Status
Terminated
 
Locations

Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41071

Status
Completed
 
Locations

Investigative Site

San Cugat del Vallès, Spain, 08190

Status
Completed
 
Locations

Investigative Site

Albacete, Spain, 02006

Status
Completed
 
Locations

Investigative Site

Valladolid, Spain, 47012

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1133

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1106

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1082

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Paris, France, 75557

Status
Completed
 
Locations

Investigative Site

BOREDAUX, France, 33076

Status
Completed
 
Locations

Investigative Site

Lyon, France, 69003

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 128 08

Status
Completed
 
Locations

Investigative Site

Praha 7, Czech Republic, 170 00

Status
Completed
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Terminated
 
Locations

Investigative Site

Dresden, Germany, 01067

Status
Terminated
 
Locations

Investigative Site

Valencia, Spain, 46014

Status
Terminated
 
Locations

Investigative Site

Vitacura, Chile, 7650710

Status
Terminated
 
Locations

Investigative Site

Santiago, Chile, 8380456

Status
Terminated
 
Locations

Investigative Site

Bogota, Colombia, 0

Status
Terminated
 
Locations

Investigative Site

Trencin, Slovakia, 91171

Status
Terminated
 
Locations

Investigative Site

Bratislava, Slovakia, 85107

Status
Terminated
 
Locations

Investigative Site

Zilina, Slovakia, 01207

Status
Terminated
 
Locations

Investigative Site

Ruzomberok, Slovakia, 03426

Status
Terminated
 
Locations

Investigative Site

Pecs, Hungary, 7621

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33143

Status
Terminated
 
Locations

Investigative Site

Louisville, United States, 40207

Status
Terminated
 
Locations

Investigative Site

Austin, United States, 78705

Status
Terminated
 
Locations

Investigative Site

Asheville, United States, 28803

Status
Terminated
 
Locations

Investigative Site

Winter Haven, United States, 33880

Status
Terminated
 
Locations

Investigative Site

Greenville, United States, 29605

Status
Terminated
 
Locations

Investigative Site

Wichita, United States, 67226

Status
Terminated
 
Locations

Investigative Site

Eunice, United States, 70535

Status
Terminated
 
Locations

Investigative Site

Campbell, United States, 95008

Status
Terminated
 
Locations

Investigative Site

Laguna Hills, United States, 92653

Status
Terminated
 
Locations

Investigative Site

Sarasota, United States, 34239

Status
Terminated
 
Locations

Investigative Site

Beverly Hills, United States, 90211

Status
Terminated
 
Locations

Investigative Site

Leawood, United States, 66211

Status
Terminated
 
Locations

Investigative Site

Grand Rapids, United States, 49525

Status
Terminated
 
Locations

Investigative Site

Decatur, United States, 30030

Status
Terminated
 
Locations

Investigative Site

Milano, Italy, 20157

Status
Terminated
 
Locations

Investigative Site

Ancona, Italy, 60126

Status
Terminated
 
Locations

Investigative Site

Padova, Italy, 35128

Status
Terminated
 
Locations

Investigative Site

Roma, Italy, 00133

Status
Terminated
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Terminated
 
Locations

Investigative Site

Roma, Italy, 00198

Status
Terminated
 
Locations

Investigative Site

Barakaldo, Spain, 48903

Status
Terminated
 
Locations

Investigative Site

Osorno, Chile, 5311138

Status
Terminated
 
Locations

Investigative Site

Metropolitana, Chile, 7510168

Status
Terminated
 
Locations

Investigative Site

Zürich, Switzerland, 8063

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 137-701

Status
Terminated
 
Locations

Investigative Site

Seongnam-si, South Korea, 463-707

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Terminated
 
Locations

Investigative Site

Stuart, United States, 34994

Status
Terminated
 
Locations

Investigative Site

Costa Mesa, United States, 92626

Status
Terminated
 
Locations

Investigative Site

Westmead, Australia, 2145

Status
Terminated
 
Locations

Investigative Site

Parramatta, Australia, 2150

Status
Terminated
 
Locations

Investigative Site

Strathfield, Australia, 2135

Status
Terminated
 
Locations

Investigative Site

Sydney, Australia, 2000

Status
Terminated
 
Locations

Investigative Site

Kowloon, Hong Kong, China

Status
Terminated
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Terminated
 
Locations

Investigative Site

Plantation, United States, 33324

Status
Terminated
 
Locations

Investigative Site

Tucson, United States, 85704

Status
Terminated
 
Locations

Investigative Site

Temple, United States, 76508

Status
Terminated
 
Locations

Investigative Site

Fort Myers, United States, 33912

Status
Terminated
 
Locations

Investigative Site

Santa Ana, United States, 92705

Status
Terminated
 
Locations

Investigative Site

Golden, United States, 80401

Status
Terminated
 
Locations

Investigative Site

Zilina, Slovakia, 01008

Status
Terminated
 
Locations

Investigative Site

London, Canada, N6A 4V2

Status
Terminated
 
Locations

Investigative Site

Calgary, Canada, T2H 0C8

Status
Terminated
 
Locations

Investigative Site

New Albany, United States, 47150

Status
Terminated
 
Locations

Investigative Site

Arcadia, United States, 91007

Status
Terminated
 
Locations

Investigative Site

Teaneck, United States, 07666

Status
Terminated
 
Locations

Investigative Site

Mountain View, United States, 94040

Status
Terminated
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Terminated
 
Locations

Investigative Site

Firenze, Italy, 50134

Status
Terminated
 
Locations

Investigative Site

Udine, Italy, 33100

Status
Terminated
 
Locations

Investigative Site

Halifax, Canada, B3H 2Y9

Status
Terminated
 
Locations

Investigative Site

Edmonton, Canada, T5H 0X5

Status
Terminated
 
Locations

Investigative Site

Vancouver, Canada, V5Z 3N9

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Terminated
 
Locations

Investigative Site

Lausanne, Switzerland, 1004

Status
Terminated
 
Locations

Investigative Site

Nedlands, Australia, 6009

Status
Terminated
 
Locations

Investigative Site

Incheon, South Korea, 405-760

Status
Terminated
 
Locations

Investigative Site

Bologna, Italy, 40138

Status
Terminated
 
Locations

Investigative Site

Sassari, Italy, 07100

Status
Terminated
 
Locations

Investigative Site

Tübingen, Germany, 72076

Status
Terminated
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Terminated
 
Locations

Investigative Site

Köln, Germany, 50937

Status
Terminated
 
Locations

Investigative Site

Leipzig, Germany, 04103

Status
Terminated
 
Locations

Investigative Site

München, Germany, 81377

Status
Terminated
 
Locations

Investigative Site

Busan, South Korea, 49241

Status
Terminated
 
Locations

Investigative Site

Mississauga, Canada, L4W 1W9

Status
Terminated
 
Locations

Investigative Site

Montreal, Canada, H4P 2S4

Status
Terminated
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Terminated
 
Locations

Investigative Site

Afula, Israel, 1834111

Status
Terminated
 
Locations

Investigative Site

Rapid City, United States, 57701

Status
Terminated
 
Locations

Investigative Site

Houston, United States, 77030

Status
Terminated
 
Locations

Investigative Site

West Mifflin, United States, 15122

Status
Terminated
 
Locations

Investigative Site

McAllen, United States, 78503

Status
Terminated
 
Locations

Investigative Site

Charlottesville, United States, 22908

Status
Terminated
 
Locations

Investigative Site

San Antonio, United States, 78240

Status
Terminated
 
Locations

Investigative Site

The Woodlands, United States, 77384

Status
Terminated
 
Locations

Investigative Site

Boston, United States, 02114

Status
Terminated
 
Locations

Investigative Site

Florissant, United States, 63031

Status
Terminated
 
Locations

Investigative Site

Montreal, Canada, H1T 2M4

Status
Terminated
 
Locations

Investigative Site

Nagasaki, Japan, 852-8511

Status
Terminated
 
Locations

Investigative Site

Nara, Japan, 630-8305

Status
Terminated
 
Locations

Investigative Site

Osaka, Japan, 533-0024

Status
Terminated
 
Locations

Investigative Site

Sapporo, Japan, 060-8604

Status
Terminated
 
Locations

Investigative Site

Kumamoto, Japan, 860-0027

Status
Terminated
 
Locations

Investigative Site

Yamato, Japan, 242-0001

Status
Terminated
 
Locations

Investigative Site

Itabashi-ku, Japan, 173-0015

Status
Terminated
 
Locations

Investigative Site

Ota-ku, Japan, 143-0013

Status
Terminated
 
Locations

Investigative Site

Chofu, Japan, 182-0024

Status
Terminated
 
Locations

Investigative Site

Taito-ku, Japan, 111-0051

Status
Terminated
 
Locations

Investigative Site

Osaka, Japan, 530-0001

Status
Terminated
 
Locations

Investigative Site

Yokohama, Japan, 222-0011

Status
Terminated
 
Locations

Investigative Site

Himeji, Japan, 671-1227

Status
Terminated
 
Locations

Investigative Site

Iga, Japan, 518-0842

Status
Terminated
 
Locations

Investigative Site

Sapporo, Japan, 004-0041

Status
Terminated
 
Locations

Investigative Site

Inba-gun, Japan, 285-0922

Status
Terminated
 
Locations

Investigative Site

Miyako-gun, Japan, 800-0344

Status
Terminated
 
Locations

Investigative Site

Fukuoka, Japan, 812-0011

Status
Terminated
 
Locations

Investigative Site

Boynton Beach, United States, 33426

Status
Terminated
 
Locations

Investigative Site

Sherbrooke, Canada, J1J 2B8

Status
Terminated
 

Trial Design