Study of the efficacy, safety and tolerability of repeated administration of eye drops containing regorafenib in newly diagnosed patients with wet orneovascular (new blood vessel growth) Age-Related Macular Degeneration (wet AMD).
- Conditions
- MedDRA version: 18.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: PTClassification code 10025409Term: Macular degenerationSystem Organ Class: 10015919 - Eye disordersneovascular age related macular degenerationMedDRA version: 18.0Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 18.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2012-003763-22-SK
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
2. Signed informed consent
3. Men and women = 50 years of age
4. 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
5. 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
6. Evidence of intraretinal and/or subretinal fluid on OCT and reviewed by the central reading center
7. 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
8. 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
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
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
16. Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration
17. Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
18. 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
27.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. For more please refer to protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>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;Primary end point(s): The primary efficacy variables in both Part A and Part B are the mean change<br>from baseline in best corrected visual acuity as measured by Early Treatment<br>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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA