Loading clinical trials...

Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT02222207•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (149)

Tucson, Arizona, United States

Arcadia, California, United States

Beverly Hills, California, United States

Campbell, California, United States

Costa Mesa, California, United States

Laguna Hills, California, United States

Mountain View, California, United States

Santa Ana, California, United States

Golden, Colorado, United States

Boynton Beach, Florida, United States

Key Dates

Start Date

October 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

June 1, 2015

Last Updated

September 8, 2016

Enrollment

ACTUAL participants

Conditions

Macular Degeneration

Interventions

Regorafenib, ophthalmic oily suspension (BAY73-4506)

DRUG

Sham IVT

PROCEDURE

Ranibizumab

DRUG

Placebo

DRUG

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

View study

RECRUITING

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

NCT07446582

Age-Related (Dry) Macular Degeneration

View study

RECRUITING

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration