Trial · NCT02222207
Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
NCT02222207, Phase 2, Terminated, Bayer; results first posted 2016-09-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration. Trials, record NCT02222207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02222207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib Eye Drops: Investigation of Efficacy and Safety in Neovascular Age Related Macular Degeneration
- NCT number
- NCT02222207
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Macular Degeneration
- Interventions
- Regorafenib, ophthalmic oily suspension (BAY73-4506), Sham IVT, Ranibizumab, Placebo
- First posted
- 2014-08-21
- Last updated
- 2016-09-08
- Other registries' IDs
- eudract:2012-003763-22
- Results first posted
- 2016-09-08
- Limitations and caveats
As the study was prematurely terminated since pre-defined proof of concept (PoC) criteria were not met in Part A, hence part B was not initiated. Part B related end points and data were not reported since it is not conducted.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline, Week 4 | 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. |
| Primary | Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A | Baseline, Week 12 | 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. |
| Secondary | 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 | Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. |
| Secondary | Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A | Baseline, Week 12 | Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline, Week 4 | Full Analysis Set (FAS): included participants who received at least one dose of study medication. | Score on scale | MEAN |
| PRIMARY | Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A | Baseline, Week 12 | Full Analysis Set (FAS): included subjects who received at least one dose of study medication. | Score on scale | MEAN |
| SECONDARY | 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 | Full Analysis Set (FAS): included subjects who received at least one dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A | Baseline, Week 12 | Full Analysis Set (FAS): included subjects who received at least one dose of study medication. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Part A Regorafenib | 1.18 | Standard Deviation 7.55 | Score on scale | |
| Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A | Part A Regorafenib | -2.36 | Standard Deviation 7.68 | Score on scale | |
| 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 | Part A Regorafenib | 42 | percentage of participants | ||
| Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A | Part A Regorafenib | 16 | percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A Regorafenib | 52 | |
| Overall Study | Treated and Valid for Full Analysis Set | Part A Regorafenib | 51 | |
| Overall Study | COMPLETED | Part A Regorafenib | 48 | |
| Overall Study | NOT COMPLETED | Part A Regorafenib | 4 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Visual acuity reduced | Eye disorders | Part A Regorafenib | 6 | 51 | |
| other | Visual acuity tests abnormal | Investigations | Part A Regorafenib | 5 | 51 | |
| serious | Acute myocardial infarction | Cardiac disorders | Part A Regorafenib | 1 | 51 | |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Part A Regorafenib | 1 | 51 | |
| serious | Visual acuity tests abnormal | Investigations | Part A Regorafenib | 1 | 51 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A Regorafenib | ||
| Total, other adverse events | Part A Regorafenib | 11 | 51 |
| Total, serious adverse events | Part A Regorafenib | 3 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02222207
GET https://conductscience.org/api/trials/v1/NCT02222207/registered