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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT02222207

Run by

Bayer

People needed

52

Starts

2014-10-01

Expected to finish

2015-06-01

Last updated by the study team

2016-09-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Arcadia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Campbell, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Mountain View, California, United States
• Study site — Santa Ana, California, United States
• Study site — Golden, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Stuart, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — New Albany, Indiana, United States
• Study site — Leawood, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Eunice, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Florissant, Missouri, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.