Trial · NCT02661711
Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study
NCT02661711, Phase 2, Completed, Moorfields Eye Hospital NHS Foundation Trust; results first posted 2024-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study. Trials, record NCT02661711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02661711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study
- NCT number
- NCT02661711
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Conditions
- Macular Oedema, Retinitis Pigmentosa
- Interventions
- Aflibercept
- First posted
- 2016-01-22
- Last updated
- 2024-05-06
- Other registries' IDs
- eudract:2015-003723-65
- Results first posted
- 2024-05-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months | at 12 months | Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months |
| Secondary | The Mean Change in Central Macular Thickness on Spectral Domain Optical Coherence Tomography (SD-OCT) From Baseline to 6 Months and Baseline to 12 Months | baseline to 6 months and baseline to 12 months | |
| Secondary | The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months | baseline to 6 months and baseline to 12 months | Mean Best Corrected Visual Acuity (BCVA) using the ETDRS visual acuity chart at 6 and 12 months. BCVA is the best possible vision an eye can see with corrective lenses, measured using the ETDRS visual acuity chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m). |
| Secondary | The Mean Change in ETDRS BCVA at 6 Months and at 12 Months | at 6 months and at 12 months | Mean ETDRS BCVA change at 6 months and at 12 months. BCVA is the best possible vision an eye can see with corrective lenses, measured using the ETDRS visual acuity chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m). |
| Secondary | The Mean Macular Volume on SDOCT at 6 and 12 Months | baseline to 6 months and baseline to 12 months | |
| Secondary | The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months | baseline to 6 months and baseline to 12 months | |
| Secondary | Report All Adverse Events and Serious Adverse Events | From date of first injection for first patient to the end of the study (17 months) | |
| Secondary | The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months | At 6 months and at 12 months | |
| Secondary | The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months | From baseline to 6 months and baseline to 12 months | |
| Secondary | The Mean Number of Intravitreal Injections Administered | 17 months (from first patient first visit to last patient last visit) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months | at 12 months | Microns | MEAN | |
| SECONDARY | The Mean Change in Central Macular Thickness on Spectral Domain Optical Coherence Tomography (SD-OCT) From Baseline to 6 Months and Baseline to 12 Months | baseline to 6 months and baseline to 12 months | Microns | MEAN | |
| SECONDARY | The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months | baseline to 6 months and baseline to 12 months | ETDRS letters | MEAN | |
| SECONDARY | The Mean Change in ETDRS BCVA at 6 Months and at 12 Months | at 6 months and at 12 months | ETDRS letters | MEAN | |
| SECONDARY | The Mean Macular Volume on SDOCT at 6 and 12 Months | baseline to 6 months and baseline to 12 months | millimeters cubed | MEAN | |
| SECONDARY | The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months | baseline to 6 months and baseline to 12 months | millimeters cubed | MEAN | |
| SECONDARY | Report All Adverse Events and Serious Adverse Events | From date of first injection for first patient to the end of the study (17 months) | participants | NUMBER | |
| SECONDARY | The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months | At 6 months and at 12 months | decibels | MEAN | |
| SECONDARY | The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months | From baseline to 6 months and baseline to 12 months | decibels | MEAN | |
| SECONDARY | The Mean Number of Intravitreal Injections Administered | 17 months (from first patient first visit to last patient last visit) | injections | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months | Intravitreal Aflibercept for RP-CMO | 413.4 | Standard Deviation 98.2 | Microns | |
| The Mean Change in Central Macular Thickness on Spectral Domain Optical Coherence Tomography (SD-OCT) From Baseline to 6 Months and Baseline to 12 Months | Intravitreal Aflibercept for RP-CMO | Mean change in CMT from baseline to 6 months | -46.2 | 95% Confidence Interval -87.6 to -4.9 | Microns |
| The Mean Change in Central Macular Thickness on Spectral Domain Optical Coherence Tomography (SD-OCT) From Baseline to 6 Months and Baseline to 12 Months | Intravitreal Aflibercept for RP-CMO | Mean change in CMT from baseline to 12 months | -47.6 | 95% Confidence Interval -80.5 to -14.6 | Microns |
| The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months | Intravitreal Aflibercept for RP-CMO | Mean BCVA at 6 months | 66.9 | Standard Deviation 10.6 | ETDRS letters |
| The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months | Intravitreal Aflibercept for RP-CMO | Mean BCVA at 12 months | 68.0 | Standard Deviation 11.1 | ETDRS letters |
| The Mean Change in ETDRS BCVA at 6 Months and at 12 Months | Intravitreal Aflibercept for RP-CMO | Mean change in BCVA from baseline to 6 months | 3.1 | Standard Deviation 6.6 | ETDRS letters |
| The Mean Change in ETDRS BCVA at 6 Months and at 12 Months | Intravitreal Aflibercept for RP-CMO | Mean change in BCVA from baseline to 12 months | 4.3 | Standard Deviation 6.9 | ETDRS letters |
| The Mean Macular Volume on SDOCT at 6 and 12 Months | Intravitreal Aflibercept for RP-CMO | Mean macular volume at 6 months | 7.9 | Standard Deviation 0.6 | millimeters cubed |
| The Mean Macular Volume on SDOCT at 6 and 12 Months | Intravitreal Aflibercept for RP-CMO | Mean macular volume at 12 months | 8.0 | Standard Deviation 0.7 | millimeters cubed |
| The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months | Intravitreal Aflibercept for RP-CMO | Mean change mac volume from baseline to 6 months | -0.3 | Standard Deviation 0.8 | millimeters cubed |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intravitreal Aflibercept for RP-CMO | 30 | |
| Overall Study | COMPLETED | Intravitreal Aflibercept for RP-CMO | 29 | |
| Overall Study | NOT COMPLETED | Intravitreal Aflibercept for RP-CMO | 1 |
Source ClinicalTrials.gov
Adverse events3
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 | Ocular adverse events | Eye disorders | Aflibercept for RP-CMO | 18 | 30 | 39 |
| other | Systemic adverse event | General disorders | Aflibercept for RP-CMO | 17 | 30 | 35 |
| serious | Sub-acute reduction of vision | Eye disorders | Aflibercept for RP-CMO | 1 | 30 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept for RP-CMO | 0 | 30 |
| Total, other adverse events | Aflibercept for RP-CMO | 26 | 30 |
| Total, serious adverse events | Aflibercept for RP-CMO | 1 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32041720 | DERIVED |
Source PubMed
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/NCT02661711
GET https://conductscience.org/api/trials/v1/NCT02661711/registered