stop_circleTerminated/Withdrawn

Macular Degeneration

Bayer Identifier:

15984

ClinicalTrials.gov Identifier:

NCT02222207

EudraCT Number:

2012-003763-22

EU CT Number:

Not Available
Regorafenib eye drops: Investigation of efficacy and safety in neovascular age related macular degeneration

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.

Key Participants Requirements

Sex

Both

Age

50 - N/A
  • - 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.
  • - 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
October 2014 - June 2015
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Regorafenib, ophthalmic oily suspension (BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praha 4, 140 00, Czech Republic
Completed
Bern, 3010, Switzerland
Terminated
Wien, 1090, Austria
Terminated
Wien, 1130, Austria
Completed
Hamburg, 20251, Germany
Terminated
Bonn, 53105, Germany
Terminated
Münster, 48145, Germany
Terminated
München, 81675, Germany
Completed
Berlin, 12203, Germany
Completed
Petah Tikva, 4941492, Israel
Completed
Rehovot, 7610001, Israel
Terminated
Tel Aviv, 6423906, Israel
Terminated
Jerusalem, 9112001, Israel
Completed
Haifa, 3109601, Israel
Completed
Haifa, 3436212, Israel
Terminated
Kfar Saba, 4428164, Israel
Completed
Zerifin, 6093000, Israel
Terminated
Beer Sheva, 8410101, Israel
Completed
Sevilla, 41013, Spain
Terminated
Valencia, 46015, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
Sevilla, 41071, Spain
Completed
San Cugat del Vallès, 08190, Spain
Completed
Albacete, 02006, Spain
Completed
Valladolid, 47012, Spain
Completed
Barcelona, 08035, Spain
Completed
Budapest, 1133, Hungary
Completed
Budapest, 1106, Hungary
Completed
Budapest, 1082, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Paris, 75557, France
Completed
BOREDAUX, 33076, France
Completed
Lyon, 69003, France
Completed
Praha 2, 128 08, Czech Republic
Completed
Praha 7, 170 00, Czech Republic
Completed
Hradec Kralove, 500 05, Czech Republic
Terminated
Dresden, 01307, Germany
Terminated
Dresden, 01067, Germany
Terminated
Valencia, 46014, Spain
Terminated
Vitacura, 7650710, Chile
Terminated
Santiago, 8380456, Chile
Terminated
Bogota, Colombia
Terminated
Trencin, 91171, Slovakia
Terminated
Bratislava, 85107, Slovakia
Terminated
Zilina, 01207, Slovakia
Terminated
Ruzomberok, 03426, Slovakia
Completed
Pecs, 7621, Hungary
Terminated
Miami, 33143, United States
Terminated
Louisville, 40207, United States
Terminated
Austin, 78705, United States
Terminated
Asheville, 28803, United States
Terminated
Winter Haven, 33880, United States
Terminated
Greenville, 29605, United States
Terminated
Wichita, 67226, United States
Terminated
Eunice, 70535, United States
Terminated
Campbell, 95008, United States
Terminated
Laguna Hills, 92653, United States
Terminated
Sarasota, 34239, United States
Terminated
Beverly Hills, 90211, United States
Terminated
Leawood, 66211, United States
Terminated
Grand Rapids, 49525, United States
Terminated
Decatur, 30030, United States
Terminated
Milano, 20157, Italy
Terminated
Ancona, 60126, Italy
Terminated
Padova, 35128, Italy
Terminated
Roma, 00133, Italy
Terminated
Milano, 20122, Italy
Terminated
Roma, 00198, Italy
Terminated
Barakaldo, 48903, Spain
Terminated
Osorno, 5311138, Chile
Terminated
Metropolitana, 7510168, Chile
Terminated
Zürich, 8063, Switzerland
Terminated
Seoul, 137-701, Korea, Republic Of
Terminated
Seongnam-si, 463-707, Korea, Republic Of
Terminated
Seoul, 135-710, Korea, Republic Of
Terminated
Seoul, 03080, Korea, Republic Of
Terminated
Stuart, 34994, United States
Terminated
Costa Mesa, 92626, United States
Terminated
Westmead, 2145, Australia
Terminated
Parramatta, 2150, Australia
Terminated
Strathfield, 2135, Australia
Terminated
Sydney, 2000, Australia
Terminated
Kowloon, Hong Kong
Terminated
Hong Kong, Hong Kong
Terminated
Plantation, 33324, United States
Terminated
Tucson, 85704, United States
Terminated
Temple, 76508, United States
Terminated
Fort Myers, 33912, United States
Terminated
Santa Ana, 92705, United States
Terminated
Golden, 80401, United States
Terminated
Zilina, 01008, Slovakia
Terminated
London, N6A 4V2, Canada
Terminated
Calgary, T2H 0C8, Canada
Terminated
New Albany, 47150, United States
Terminated
Arcadia, 91007, United States
Terminated
Teaneck, 07666, United States
Terminated
Mountain View, 94040, United States
Terminated
Milano, 20132, Italy
Terminated
Firenze, 50134, Italy
Terminated
Udine, 33100, Italy
Terminated
Halifax, B3H 2Y9, Canada
Terminated
Edmonton, T5H 0X5, Canada
Terminated
Vancouver, V5Z 3N9, Canada
Terminated
Seoul, 05505, Korea, Republic Of
Terminated
Lausanne, 1004, Switzerland
Terminated
Nedlands, 6009, Australia
Terminated
Incheon, 405-760, Korea, Republic Of
Terminated
Bologna, 40138, Italy
Terminated
Hong Kong, Hong Kong
Terminated
Sassari, 07100, Italy
Terminated
Tübingen, 72076, Germany
Terminated
Mainz, 55131, Germany
Terminated
Köln, 50937, Germany
Terminated
Leipzig, 04103, Germany
Terminated
München, 81377, Germany
Terminated
Busan, 49241, Korea, Republic Of
Terminated
Mississauga, L4W 1W9, Canada
Terminated
Montreal, H4P 2S4, Canada
Terminated
Ramat Gan, 5262000, Israel
Terminated
Afula, 1834111, Israel
Terminated
Rapid City, 57701, United States
Terminated
Houston, 77030, United States
Terminated
West Mifflin, 15122, United States
Terminated
McAllen, 78503, United States
Terminated
Austin, 78705, United States
Terminated
Charlottesville, 22908, United States
Terminated
San Antonio, 78240, United States
Terminated
The Woodlands, 77384, United States
Terminated
Greenville, 29605, United States
Terminated
Boston, 02114, United States
Terminated
Florissant, 63031, United States
Terminated
Montreal, H1T 2M4, Canada
Terminated
Nagasaki, 852-8511, Japan
Terminated
Nara, 630-8305, Japan
Terminated
Osaka, 533-0024, Japan
Terminated
Sapporo, 060-8604, Japan
Terminated
Kumamoto, 860-0027, Japan
Terminated
Yamato, 242-0001, Japan
Terminated
Itabashi-ku, 173-0015, Japan
Terminated
Ota-ku, 143-0013, Japan
Terminated
Chofu, 182-0024, Japan
Terminated
Taito-ku, 111-0051, Japan
Terminated
Osaka, 530-0001, Japan
Terminated
Yokohama, 222-0011, Japan
Terminated
Himeji, 671-1227, Japan
Terminated
Iga, 518-0842, Japan
Terminated
Sapporo, 004-0041, Japan
Terminated
Inba-gun, 285-0922, Japan
Terminated
Miyako-gun, 800-0344, Japan
Terminated
Fukuoka, 812-0011, Japan
Terminated
Boynton Beach, 33426, United States
Terminated
Sherbrooke, J1J 2B8, Canada

Primary Outcome

  • Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A
    Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant’s ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline, Week 4
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A
    Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline, Week 12
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of Participants With Individual Changes in BCVA of greater than equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A
    Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.
    date_rangeTime Frame:
    Week 4, Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A
    Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.
    date_rangeTime Frame:
    Baseline, Week 12
    enhanced_encryption
    Safety Issue:
    No

Trial design

A combined Phase IIa / IIb study of the efficacy, safety, and tolerability of repeated topical doses of regorafenib eye drops, in treatment-naïve subjects with neovascular age related macular degeneration
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
8

Additional Information

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