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

Macular Degeneration Clinical Trial

— DREAM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222207
• Other study ID #: 15984
• Secondary ID: 2012-003763-22
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2014
• Last updated: November 19, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlFrance: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesIsrael: Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSwitzerland: SwissmedicUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Procedure:
• Sham IVT
Sham injections

Drug:
• Ranibizumab
Subjects receive Ranibizumab as intravitreal injection
• Placebo
Placebo eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Chile,  Colombia,  Czech Republic,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Slovakia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BCVA (Best corrected visual acuity) from baseline to week 4 for study part A		4 weeks	No
Primary	Change in BCVA from baseline to week 12 for study part A		12 weeks	No
Primary	Change in BCVA from baseline to week 4 for study part B		4 weeks	No
Primary	Change in BCVA from baseline to week 12 for study part B		12 weeks	No
Secondary	Proportion of subjects with individual changes in BCVA of = 0 letters of vision for study part A		Week 4 to Week 12	No
Secondary	Proportion of subjects with a loss of = 10 letters for study part A		Baseline to Week 12	No
Secondary	Proportion of subjects with individual changes in BCVA of = 0 letters of vision for study part B		Week 4 to Week 12	No
Secondary	Proportion of subjects with a loss of = 10 letters for study part B		Baseline to Week 12	No

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