Trial Outcomes & Findings for Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study (NCT NCT02661711)

NCT ID: NCT02661711

Last Updated: 2024-05-06

Results Overview

Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: at 12 months
• Results posted on: 2024-05-06

Participant Flow

Participant milestones

Measure	Intravitreal Aflibercept for RP-CMO 30 patients recruited for this study, all of which receive the active drug, aflibercept
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study

Baseline characteristics by cohort

Measure	Intravitreal Aflibercept for RP-CMO n=30 Participants 30 patients recruited for this study, all of which receive the active drug, aflibercept
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	30 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 months

Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months	413.4 Microns Standard Deviation 98.2

SECONDARY outcome

Timeframe: baseline to 6 months and baseline to 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
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 Mean change in CMT from baseline to 6 months	-46.2 Microns Interval -87.6 to -4.9
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 Mean change in CMT from baseline to 12 months	-47.6 Microns Interval -80.5 to -14.6

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months Mean BCVA at 6 months	66.9 ETDRS letters Standard Deviation 10.6
The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months Mean BCVA at 12 months	68.0 ETDRS letters Standard Deviation 11.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Change in ETDRS BCVA at 6 Months and at 12 Months Mean change in BCVA from baseline to 6 months	3.1 ETDRS letters Standard Deviation 6.6
The Mean Change in ETDRS BCVA at 6 Months and at 12 Months Mean change in BCVA from baseline to 12 months	4.3 ETDRS letters Standard Deviation 6.9

SECONDARY outcome

Timeframe: baseline to 6 months and baseline to 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Macular Volume on SDOCT at 6 and 12 Months Mean macular volume at 6 months	7.9 millimeters cubed Standard Deviation 0.6
The Mean Macular Volume on SDOCT at 6 and 12 Months Mean macular volume at 12 months	8.0 millimeters cubed Standard Deviation 0.7

SECONDARY outcome

Timeframe: baseline to 6 months and baseline to 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months Mean change mac volume from baseline to 6 months	-0.3 millimeters cubed Standard Deviation 0.8
The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months Mean change mac volume from baseline to 12 months	-0.3 millimeters cubed Standard Deviation 0.7

SECONDARY outcome

Timeframe: From date of first injection for first patient to the end of the study (17 months)

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=30 eyes Intravitreal aflibercept for RP-CMO
Report All Adverse Events and Serious Adverse Events Non-serious adverse events in whole study	26 participants
Report All Adverse Events and Serious Adverse Events Serious adverse events in whole study	1 participants

SECONDARY outcome

Timeframe: At 6 months and at 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months Mean retinal sensitivity at 6 months	4.92 decibels Standard Deviation 3.49
The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months Mean retinal sensitivity at 12 months	4.93 decibels Standard Deviation 3.49

SECONDARY outcome

Timeframe: From baseline to 6 months and baseline to 12 months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months Mean change ret sens from baseline to 6 months	-1.23 decibels Standard Deviation 2.24
The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months Mean change ret sens from baseline to 12 months	-1.09 decibels Standard Deviation 2.10

SECONDARY outcome

Timeframe: 17 months (from first patient first visit to last patient last visit)

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 eyes Intravitreal aflibercept for RP-CMO
The Mean Number of Intravitreal Injections Administered	7 injections Interval 6.0 to 9.0

SECONDARY outcome

Timeframe: at 6 months

Population: 29

The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months

Outcome measures

Measure	Intravitreal Aflibercept for RP-CMO n=29 Participants Intravitreal aflibercept for RP-CMO
The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months	414.8 micron Standard Deviation 96.4

Adverse Events

Aflibercept for RP-CMO

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aflibercept for RP-CMO n=30 participants at risk This arm received Aflibercept for RP-CMO
Eye disorders Sub-acute reduction of vision	3.3% 1/30 • Up to 17 months for the study duration. Systematic collection at every patient visit

Other adverse events

Measure	Aflibercept for RP-CMO n=30 participants at risk This arm received Aflibercept for RP-CMO
Eye disorders Ocular adverse events	60.0% 18/30 • Number of events 39 • Up to 17 months for the study duration. Systematic collection at every patient visit
General disorders Systemic adverse event	56.7% 17/30 • Number of events 35 • Up to 17 months for the study duration. Systematic collection at every patient visit

Additional Information

Tumelo Kaminskas

Moorfields Eye Hospital

Phone: 02072533411

Email: moorfields.resadmin@nhs.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place