Study of the efficacy, safety and tolerability of repeated administration of eye drops containing regorafenib in newly diagnosed patients with "wet" or neovascular ("new blood vessel growth") Age-Related Macular Degeneration (wet AMD).

• Register: EUCTR
• Last refreshed on: 28 December 2015
• Main ID: EUCTR2012-003763-22-DE
• Date of registration: 27/05/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: Study of the efficacy, safety and tolerability of repeated administration of eye drops containing regorafenib in newly diagnosed patients with "wet" or neovascular ("new blood vessel growth") Age-Related Macular Degeneration (wet AMD).
• 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 - Regorafenib eye drops: Investigation of efficacy and safety in wet AMD
• Date of first enrolment: 19/08/2014
• Target sample size: 540
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003763-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Part A: single-arm, open-label design Part B: double-masked, active-controlled If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Comparator: other medicinal product and placebo only for part B Number of treatment arms in the trial: 8

Countries of recruitment

Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Singapore, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

• Name: Clinical Trials Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
Eligible subjects will have received a diagnosis of neovascular age-related macular degeneration in one or both eyes; however, only one eye will be enrolled in this study, the study eye. All ophthalmic eligibility criteria apply only to the study eye unless otherwise specified. The main criteria for inclusion in Part A and Part B are:
• Signed informed consent
• Men and women = 50 years of age
• Active primary subfoveal choroidal neovascularization lesions secondary to age related macular degeneration, including juxtafoveal lesions that affect the fovea as evidenced by fluorescein angiography in the study eye and reviewed by the central reading center
• Evidence of intraretinal and/or subretinal fluid on OCT and reviewed by the central reading center
• The area of choroidal neovascularization must occupy at least 50% of total lesion in the study eye, as determined by fluorescein angiography review at the central reading center
• Evidence of intraretinal and/or subretinal fluid on optical coherence tomography
• Early Treatment Diabetic Retinopathy Study best corrected visual acuity 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
Subjects who participate in Part A of the protocol are ineligible for Part B.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 445

Exclusion criteria:
1.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
2.Any findings in the study eye that would limit the potential to benefit from study treatment, or could otherwise confound interpretation of the results such as total lesion size (including structural damage to the center of macula, neovascularization, scar, blood) >12 disc areas (30.5 mm2) and subfoveal fibrosis as assessed by FA
3.Only one functional eye, even if that eye is otherwise eligible for the study
4.Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
5.Prior treatment with any systemic anti-VEGF agent
6.Use of systemic or ocular treatment with an investigational drug within 12 weeks prior to start of study treatment
7.Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration
8.Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
9.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
10.Lactating women and women of child-bearing potential with either a positive pregnancy test result or no pregnancy test at s are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
12.History or current use of long-acting steroids, either systemically or injected intraocularly, periocularly, subconjunctivally
15. Intraocular pressure = 25 millimeters of mercury (mmHg) in the study eye as well as uncontrolled glaucoma


For more information please refer to protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

neovascular age related macular degeneration
MedDRA version: 17.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: LLT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 - Eye disorders
MedDRA version: 17.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Product Name: Regorafenib (BAY 73-4506) eye drops; 2% (w/v)
Product Code: BAY 73-4506
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: REGORAFENIB
CAS Number: 1019206-88-2
Current Sponsor code: BAY 73-4506
Other descriptive name: Regorafenib monohydrate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Eye drops
Route of administration of the placebo: Ocular use

Product Name: Regorafenib (BAY 73-4506) eye drops; 3% (w/v)
Product Code: BAY 73-4506
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: REGORAFENIB
CAS Number: 1019206-88-2
Current Sponsor code: BAY 73-4506
Other descriptive name: Regorafenib monohydrate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Eye drops
Route of administration of the placebo: Ocular use

Trade Name: Lucentis
Product Name: Ranibizumab (Lucentis)
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Current Sponsor code: NA
Other descriptive name: RANIBIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravitreal use

Primary Outcome(s)

Primary end point(s): The primary efficacy variables in both Part A and Part B are the mean change
from baseline in best corrected visual acuity as measured by Early Treatment
Diabetic Retinopathy Study letter score at Study Week 4 and Study Week 12.

Timepoint(s) of evaluation of this end point: Study Week 4 and Study Week 12

Main Objective: Assess the effect of treatment with regorafenib eye drops on visual acuity at Study Week 4 and at Study Week 12 in subjects with subfoveal choroidal neovascularization due to age related macular degeneration.
For Part B: in addition, explore an optimal dosing regimen

Secondary Objective: Evaluate the effect of treatment with regorafenib eye drops on ocular safety and tolerability

Secondary Outcome(s)

Secondary end point(s): NA

Timepoint(s) of evaluation of this end point: NA

Secondary ID(s)

BAY73-4506/15984

2012-003763-22-HU

Source(s) of Monetary Support

Bayer HealthCare AG