stop_circleTerminated/Withdrawn
Macular Degeneration
Bayer Identifier:
15984
ClinicalTrials.gov Identifier:
EudraCT Number:
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.
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
BothAge
50 - N/ATrial summary
Enrollment Goal
52Trial Dates
October 2014 - June 2015Phase
Phase 2Could I Receive a placebo
YesProducts
Regorafenib, ophthalmic oily suspension (BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 AParticipants 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 4enhanced_encryptionNoSafety Issue:
- Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part AParticipants 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 12enhanced_encryptionNoSafety Issue:
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 AParticipants 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 12enhanced_encryptionNoSafety Issue:
- Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part AParticipants 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 12enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
8