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

NCT02222207 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-09-08

Study results available
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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.

Conditions

  • Macular Degeneration

Interventions

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

DRUG

Placebo

Placebo eye drops

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Slovakia
  • South Korea
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02222207 on ClinicalTrials.gov