NCT02222207|TerminatedPhase 2ResultsDMC

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

DREAM

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

Bayer ClinicalTrials.gov

Compare

2 other identifiers

159842012-003763-22

Study Type

interventional

Target

Locations

17 countries

Sites

144

Timeline

RegisteredAug 2014

StartedOct 2014

CompletionJun 2015

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach

17 countries

144 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

August 20, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

September 8, 2016

Completed

Last Updated

September 8, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

August 20, 2014

Results QC Date

June 11, 2016

Last Update Submit

July 25, 2016

Conditions

Macular Degeneration

Keywords

neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

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
Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant's ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
Baseline, Week 4
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A
Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
Baseline, Week 12

Secondary Outcomes (2)

Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A
Week 4, Week 12
Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A
Baseline, Week 12

Study Arms (8)

Regorafenib [A]

EXPERIMENTAL

Part A: Patients will receive Regorafenib eye drops

Drug: Regorafenib, ophthalmic oily suspension (BAY73-4506)