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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02222207




Registration number
NCT02222207
Ethics application status
Date submitted
20/08/2014
Date registered
21/08/2014
Date last updated
8/09/2016

Titles & IDs
Public title
Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
Scientific 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
Secondary ID [1] 0 0
2012-003763-22
Secondary ID [2] 0 0
15984
Universal Trial Number (UTN)
Trial acronym
DREAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Regorafenib, ophthalmic oily suspension (BAY73-4506)
Treatment: Surgery - Sham IVT
Treatment: Drugs - Ranibizumab
Treatment: Drugs - Placebo

Experimental: Regorafenib [A] - Part A: Patients will receive Regorafenib eye drops

Experimental: Regorafenib [B1] - Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks

Experimental: Regorafenib [B2] - Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks

Experimental: Regorafenib [B3] - Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks

Experimental: Regorafenib [B4] - Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks

Experimental: Regorafenib [B5] - Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks

Experimental: Regorafenib [B6] - Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks

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


Treatment: Drugs: Regorafenib, ophthalmic oily suspension (BAY73-4506)
Subjects receive Regorafenib as eye drops

Treatment: Surgery: Sham IVT
Sham injections

Treatment: Drugs: Ranibizumab
Subjects receive Ranibizumab as intravitreal injection

Treatment: Drugs: Placebo
Placebo eye drops

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Week 4
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 4, Week 12
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, Week 12

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
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- Strathfield
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- Sydney
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- Westmead
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- Nedlands
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- Parramatta
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2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
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2145 - Westmead
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2150 - Parramatta
Recruitment outside Australia
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Switzerland
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Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02222207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02222207