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

Conditions

• Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Regorafenib, ophthalmic oily suspension (BAY73-4506) — DRUG
  Subjects receive Regorafenib as eye drops
• Sham IVT — PROCEDURE
  Sham injections
• Ranibizumab — DRUG
  Subjects receive Ranibizumab as intravitreal injection
• Placebo — DRUG
  Placebo eye drops

Study Details

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 Dates

First listed

Aug 21, 2014

Start date

Oct 31, 2014

Status verified

Jul 2016

Primary completion

May 31, 2015

Completion

Jun 30, 2015

Study Design

Enrollment

52 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regorafenib [A]
  Part A: Patients will receive Regorafenib eye drops
• Experimental: Regorafenib [B1]
  Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Experimental: Regorafenib [B2]
  Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Experimental: Regorafenib [B3]
  Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Experimental: Regorafenib [B4]
  Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Experimental: Regorafenib [B5]
  Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Experimental: Regorafenib [B6]
  Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks
• Active Comparator: Ranibizumab
  Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A [ Time Frame: Baseline, Week 4 ]

Locations (37)

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