Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration (NCT NCT04126317)
NCT ID: NCT04126317
Last Updated: 2023-08-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Up to Week 44
Results posted on
2023-08-14
Participant Flow
Of the 245 participants screened, 106 participants were randomized and treated.
Participant milestones
| Measure |
Intravitreal Aflibercept Injection (IAI)
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Intravitreal Aflibercept Injection (IAI)
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 Participants
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 Participants
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.7 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
77.0 years
STANDARD_DEVIATION 7.69 • n=7 Participants
|
77.4 years
STANDARD_DEVIATION 7.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic of Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of Participants without Retinal Fluid in the Center Subfield of Study Eye
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 44Population: Safety analysis set (SAF): All randomized participants who received any study drug; it was based on the treatment received (as treated).
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 Participants
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 Participants
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Participants with at least 1 Ocular TEAE of the Study Eye
|
20 Participants
|
20 Participants
|
|
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Participants with at least 1 Ocular TEAE of the Fellow Eye
|
13 Participants
|
13 Participants
|
|
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Participants with at least 1 Non-Ocular TEAE
|
24 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to Week 44Population: SAF: All randomized participants who received any study drug; it was based on the treatment received (as treated)
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 Participants
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 Participants
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Number of Participants With at Least One Serious TEAE
Participants with at least 1 Ocular Serious TEAE of the Study Eye
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least One Serious TEAE
Participants with at least 1 Ocular Serious TEAE of the Fellow Eye
|
0 Participants
|
0 Participants
|
|
Number of Participants With at Least One Serious TEAE
Participants with at least 1 Non-Ocular Serious TEAE
|
4 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: Full analysis set (FAS): All randomized participants; it was based on the treatment allocated (as randomized). Missing post-baseline values for a given participant were imputed using the last observation carried forward (LOCF).
Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 Participants
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 Participants
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
|
18 Participants
|
27 Participants
|
Adverse Events
Intravitreal Aflibercept Injection (IAI)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
High-Dose Aflibercept Injection (HD)
Serious events: 7 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 participants at risk
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 participants at risk
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
|
Infections and infestations
COVID-19
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Retinal tear Study Eye
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Visual impairment Study Eye
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Visual acuity reduced Study Eye
|
1.9%
1/53 • Number of events 2 • From first dose up to Week 44 (end of study)
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
Other adverse events
| Measure |
Intravitreal Aflibercept Injection (IAI)
n=53 participants at risk
Treatment-naïve participants with neovascular "wet" age-related macular degeneration (nAMD) were randomized in a 1:1 ratio to receive IAI (2 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
High-Dose Aflibercept Injection (HD)
n=53 participants at risk
Treatment-naïve participants with nAMD were randomized in a 1:1 ratio to receive HD aflibercept (8 mg) monthly for 3 initial injections (baseline, week 4, and week 8), followed by additional doses at weeks 20 and 32.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
2/53 • Number of events 2 • From first dose up to Week 44 (end of study)
|
5.7%
3/53 • Number of events 4 • From first dose up to Week 44 (end of study)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53 • From first dose up to Week 44 (end of study)
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Conjunctival haemorrhage Fellow Eye
|
1.9%
1/53 • Number of events 1 • From first dose up to Week 44 (end of study)
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Neovascular age-related macular degeneration Fellow Eye
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
7.5%
4/53 • Number of events 4 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Vitreous detachment Fellow Eye
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
1.9%
1/53 • Number of events 2 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Conjunctival haemorrhage Study Eye
|
3.8%
2/53 • Number of events 2 • From first dose up to Week 44 (end of study)
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Neovascular age-related macular degeneration Study Eye
|
7.5%
4/53 • Number of events 4 • From first dose up to Week 44 (end of study)
|
3.8%
2/53 • Number of events 2 • From first dose up to Week 44 (end of study)
|
|
Eye disorders
Vitreous detachment Study Eye
|
5.7%
3/53 • Number of events 3 • From first dose up to Week 44 (end of study)
|
7.5%
4/53 • Number of events 4 • From first dose up to Week 44 (end of study)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER