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Macular DegenerationPhase 2DREAMNCT02222207

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

A Phase 2 study testing Regorafenib, ophthalmic oily suspension (BAY73-4506) and Ranibizumab in people with Macular Degeneration, run by Bayer at 149 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Regorafenib, ophthalmic oily suspension (BAY73-4506) and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
149 sitesin 18 countries
Study dates
Oct 2014to Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

149 sites in 18 countries.

149 sites in 18 countries

United States37 sites

  • Study site

    Arcadia, California, 91007

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Austin, Texas, 78705

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Campbell, California, 95008

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Decatur, Georgia, 30030

  • Study site

    Eunice, Louisiana, 70535

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Golden, Colorado, 80401

  • Study site

    Grand Rapids, Michigan, 49525

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Houston, Texas, 77030

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Leawood, Kansas, 66211

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    McAllen, Texas, 78503

  • Study site

    Miami, Florida, 33143

  • Study site

    Mountain View, California, 94040

  • Study site

    New Albany, Indiana, 47150

  • Study site

    Plantation, Florida, 33324

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    San Antonio, Texas, 78240

  • Study site

    Santa Ana, California, 92705

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Stuart, Florida, 34994

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    Temple, Texas, 76508

  • Study site

    The Woodlands, Texas, 77384

  • Study site

    Tucson, Arizona, 85704

  • Study site

    West Mifflin, Pennsylvania, 15122

  • Study site

    Wichita, Kansas, 67226

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Japan18 sites

  • Study site

    Chōfu, Tokyo, 182-0024

  • Study site

    Fukuoka, Fukuoka, 812-0011

  • Study site

    Himeji, Hyōgo, 671-1227

  • Study site

    Iga, Mie-ken, 518-0842

  • Study site

    Inba-gun, Chiba, 285-0922

  • Study site

    Kumamoto, Kumamoto, 860-0027

  • Study site

    Miyako-gun, Fukuoka, 800-0344

  • Study site

    Nagasaki, Nagasaki, 852-8511

  • Study site

    Nara, Nara, 630-8305

  • Study site

    Osaka, Osaka, 530-0001

  • Study site

    Osaka, Osaka, 533-0024

  • Study site

    Ōta-ku, Tokyo, 143-0013

  • Study site

    Sapporo, Hokkaido, 004-0041

  • Study site

    Sapporo, Hokkaido, 060-8604

  • Study site

    tabashi City, Tokyo, 173-0015

  • Study site

    Taito-ku, Tokyo, 111-0051

  • Study site

    Yamato, Kanagawa, 242-0001

  • Study site

    Yokohama, Kanagawa, 222-0011

Other trials in Japan

Germany12 sites

  • Study site

    Berlin, State of Berlin, 12203

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Dresden, Saxony, 01067

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20251

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81377

  • Study site

    München, Bavaria, 81675

  • Study site

    Münster, North Rhine-Westphalia, 48145

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Israel11 sites

  • Study site

    Afula, 1834111

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Haifa, 3436212

  • Study site

    Jerusalem, 9112001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 5262000

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tsrifin, 6093000

Other trials in Israel

Italy11 sites

  • Study site

    Ancona, 60126

  • Study site

    Bologna, 40138

  • Study site

    Florence, Tuscany, 50134

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20157

  • Study site

    Milan, 20132

  • Study site

    Padova, Veneto, 35128

  • Study site

    Rome, Lazio, 00133

  • Study site

    Rome, Lazio, 00198

  • Study site

    Sassari, 07100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Spain10 sites

  • Study site

    Albacete, Albacete, 02006

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    San Cugat Del Vallès, Barcelona, 08190

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valencia, 46015

  • Study site

    Valladolid, Valladolid, 47012

Other trials in Spain

Canada9 sites

  • Study site

    Calgary, Alberta, T2H 0C8

  • Study site

    Edmonton, Alberta, T5H 0X5

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Mississauga, Ontario, L4W 1W9

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H4P 2S4

  • Study site

    Sherbrooke, Quebec, J1J 2B8

  • Study site

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

South Korea7 sites

  • Study site

    Busan, 49241

  • Study site

    Incheon, 405-760

  • Study site

    Seongnam-si, Gyeonggido, 463-707

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 137-701

Other trials in South Korea

Australia5 sites

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Parramatta, 2150

  • Study site

    Strathfield, New South Wales, 2135

  • Study site

    Sydney, New South Wales, 2000

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Hungary5 sites

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Debrecen, 4032

  • Study site

    Pécs, 7621

Other trials in Hungary

Slovakia5 sites

  • Study site

    Bratislava, 85107

  • Study site

    Ružomberok, 03426

  • Study site

    Trenčín, 91171

  • Study site

    Žilina, 01008

  • Study site

    Žilina, 01207

Other trials in Slovakia

Chile4 sites

  • Study site

    Metropolitana, Santiago Metropolitan, 7510168

  • Study site

    Osorno, Los Lagos Region, 5311138

  • Study site

    Santiago, Santiago Metropolitan, 8380456

  • Study site

    Vitacura, Santiago Metropolitan, 7650710

Other trials in Chile

Czechia4 sites

  • Study site

    Hradec Králové, 500 05

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 00

  • Study site

    Prague, 170 00

Other trials in Czechia

France3 sites

  • Study site

    Boredaux, 33076

  • Study site

    Lyon, 69003

  • Study site

    Paris, Cedex 12, 75557

Other trials in France

Switzerland3 sites

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Lausanne, 1004

  • Study site

    Zurich, Canton of Zurich, 8063

Other trials in Switzerland

Austria2 sites

  • Study site

    Vienna, State of Vienna, 1130

  • Study site

    Vienna, 1090

Other trials in Austria

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

Other trials in Hong Kong

Colombia1 site

  • Study site

    Bogotá, Bogota D.C., 0

Other trials in Colombia

About this study

Official title: 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

Part A (Phase IIa):

Primary objectives:

Read more

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.

Being tested
Regorafenib, ophthalmic oily suspension (BAY73-4506), Sham IVT, Ranibizumab, Placebo
Keywords
neovascular Age-related Macular Degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regorafenib, ophthalmic oily suspension (BAY73-4506)Drug

    Subjects receive Regorafenib as eye drops

  • Sham IVTProcedure or surgery

    Sham injections

  • RanibizumabDrug

    Subjects receive Ranibizumab as intravitreal injection

  • PlaceboDrug

    Placebo eye drops

Study groups in NCT02222207
Study groupRoleWhat they receive
Regorafenib [A]ExperimentalPart A: Patients will receive Regorafenib eye drops
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506)
Regorafenib [B1]ExperimentalPart B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
Regorafenib [B2]ExperimentalPart B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
Regorafenib [B3]ExperimentalPart B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
Regorafenib [B4]ExperimentalPart B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
Regorafenib [B5]ExperimentalPart B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
Regorafenib [B6]ExperimentalPart B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks
Receives: Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506); Procedure: Sham IVT
RanibizumabActive comparatorRanibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens
Receives: Drug: Ranibizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 4

  2. 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.

    Measured: Baseline, Week 12

Secondary outcomes (2)

  1. 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.

    Measured: Week 4, Week 12

  2. 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.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02222207
Sponsor's protocol ID
15984
Other IDs
2012-003763-22
Acronym
DREAM
Status last verified
Jul 2016
First submitted
20 Aug 2014
Last updated
8 Sep 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib, ophthalmic oily suspension (BAY73-4506) and Ranibizumab in people with Macular Degeneration, run by Bayer at 149 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Japan, Germany, Israel, Italy and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02222207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.

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