Trial Outcomes & Findings for A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment (NCT NCT05473715)
NCT ID: NCT05473715
Last Updated: 2024-10-16
Results Overview
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
TERMINATED
PHASE4
3 participants
Approximately 11 weeks
2024-10-16
Participant Flow
Study enrolled participants in 2 countries, between 25 Apr 2023 (first participant first visit) and 11 Jul 2023 (termination date).
Four participants were screened; 3 were randomized and treated.
Participant milestones
| Measure |
Customized Treatment Interval
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Customized Treatment Interval
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
|---|---|---|
|
Overall Study
Trial terminate
|
2
|
1
|
Baseline Characteristics
A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment
Baseline characteristics by cohort
| Measure |
Customized Treatment Interval
n=2 Participants
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
n=1 Participants
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 11 weeksPopulation: The study was terminated before any participant reached primary completion (Week 36), therefore no analyses were performed.
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 11 weeksPopulation: The study was terminated before any participant reached either primary completion (Week 36) or study completion (Week 52), therefore no analyses were performed.
Participant took aflibercept on study eye.
Outcome measures
| Measure |
Customized Treatment Interval
n=2 Participants
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
n=1 Participants
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
|---|---|---|
|
Number of Intravitreal (IVT) Aflibercept Injections
0 aflibercept injection
|
1 Participants
|
0 Participants
|
|
Number of Intravitreal (IVT) Aflibercept Injections
1 aflibercept injection
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 11 weeksPopulation: The study was terminated before any participant reached study completion (Week 52), therefore no analyses were performed.
Pre-defined treatment intervals are: ≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks.
Outcome measures
| Measure |
Customized Treatment Interval
n=2 Participants
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
n=2 Participants
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
|---|---|---|
|
Number of Patients Achieving Pre-defined Treatment Intervals
|
NA Participants
The study was terminated before any participant took the second injection.
|
NA Participants
The study was terminated before any participant took the second injection.
|
SECONDARY outcome
Timeframe: Approximately 11 weeksPopulation: The study was terminated before any participant reached study completion (Week 52), therefore no analyses were performed.
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 11 weeksAEs that occurred or worsened after the first injection of study drug and no later than 30 days after the last injection of study drug was considered as treatment-emergent adverse events (TEAEs).
Outcome measures
| Measure |
Customized Treatment Interval
n=2 Participants
After the initial study injection at baseline, participants received their next study injection at Week 16. Participants in this study arm were also issued a home monitoring device, which allowed for regular OCT monitoring (at least 5 times a week) at home.
|
Standard T&E
n=1 Participants
Participants received treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria were met.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Customized Treatment Interval
Standard T&E
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place