Trial Outcomes & Findings for Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO (NCT NCT02800642)
NCT ID: NCT02800642
Last Updated: 2020-07-08
Results Overview
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
Baseline, Week 24 and Week 76
Results posted on
2020-07-08
Participant Flow
A total of 244 participants were screened in 42 study centers in 8 countries, the first subject first visit was on 10/Jun/2016 and last subject last visit was on 31/Jun/2019
Of the 244 screened participants, 162 subjects completed screening and entered the treatment period
Participant milestones
| Measure |
Intravitreal (IVT) Aflibercept
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Overall Study
STARTED
|
162
|
|
Overall Study
COMPLETED
|
137
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Intravitreal (IVT) Aflibercept
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Other
|
10
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
Baseline characteristics by cohort
| Measure |
Intravitreal (IVT) Aflibercept
n=162 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24 and Week 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment. Last observation carried forward (LOCF) imputation method.
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
|
65.6 percent
95% Confidence Interval 57.7 • Interval 57.7 to 72.9
|
PRIMARY outcome
Timeframe: From the last actual visit of the initiation phase to Week 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
|
45.0 percent
95% Confidence Interval 37.1 • Interval 37.1 to 53.1
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Participants in full analysis set (received any study drug, had a baseline BCVA assessment and at least one post-baseline BCVA assessment) that completed study
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=150 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Mean Treatment Interval Between Injections
|
6.37 weeks
Standard Deviation 1.150 • Interval 1.15 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24, 52, and 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Absolute BCVA letter score at baseline
|
51.9 scores
Standard Deviation 16.8 • Interval 16.8 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Absolute BCVA letter score at Week 24
|
72.4 scores
Standard Deviation 16.6 • Interval 16.6 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Absolute BCVA letter score at Week 52
|
71.8 scores
Standard Deviation 18.1 • Interval 18.1 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Absolute BCVA letter score at Week 76
|
72.3 scores
Standard Deviation 18.5 • Interval 18.5 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Change from baseline at Week 24
|
20.4 scores
Standard Deviation 17.0 • Interval 17.0 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Change from baseline at Week 52
|
19.9 scores
Standard Deviation 19.1 • Interval 19.1 to
|
|
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
Change from baseline at Week 76
|
20.3 scores
Standard Deviation 19.5 • Interval 19.5 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24, 52 and 76Population: Included all participants who received any study drug, had a baseline CRT assessment, and had post-baseline CRT assessment at Week 24, 52 and 76
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=158 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Absolute CRT at baseline
|
759.9 micrometer
Standard Deviation 246.0 • Interval 246.0 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Absolute CRT at Week 24
|
271.2 micrometer
Standard Deviation 53.1 • Interval 53.1 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Absolute CRT at Week 52
|
279.8 micrometer
Standard Deviation 106.8 • Interval 106.8 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Absolute CRT at Week 76
|
265.4 micrometer
Standard Deviation 57.9 • Interval 57.9 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Change from baseline at Week 24
|
-488.9 micrometer
Standard Deviation 254.6 • Interval 254.6 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Change from baseline at Week 52
|
-481.3 micrometer
Standard Deviation 266.5 • Interval 266.5 to
|
|
The Change in Central Retinal Thickness (CRT) From Baseline
Change from baseline at Week 76
|
-496.1 micrometer
Standard Deviation 252.4 • Interval 252.4 to
|
SECONDARY outcome
Timeframe: From baseline to Week 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Number of Injections Per Participant
|
12.2 injections
Standard Deviation 2.53 • Interval 2.53 to
|
SECONDARY outcome
Timeframe: Baseline and Week 24, Week 52Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Week 24
|
68.8 percent
95% Confidence Interval 61.0 • Interval 61.0 to 75.8
|
|
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Week 52
|
68.1 percent
95% Confidence Interval 60.3 • Interval 60.3 to 75.3
|
SECONDARY outcome
Timeframe: Baseline and Week 24, 52 and 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment
The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, \<10 ischemic disc area, \>=10 ischemic disc area and missing status
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: no to <10
|
4.4 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: no to >=10
|
3.8 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: no to missing
|
6.3 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: <10 to no
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: <10 to >=10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: <10 to missing
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: >=10 to no
|
1.3 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: >=10 to <10
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: >=10 to missing
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: missing to no
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: missing to <10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: missing to >=10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 24: no status change
|
81.9 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: no to <10
|
5.0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: no to >=10
|
5.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: no to missing
|
10.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: <10 to no
|
1.9 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: <10 to >=10
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: <10 to missing
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: >=10 to no
|
1.9 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: >=10 to <10
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: >=10 to missing
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: missing to no
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: missing to <10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: missing to >=10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 52: no status change
|
73.8 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: no to <10
|
3.1 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: no to >=10
|
4.4 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: no to missing
|
18.1 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: <10 to no
|
1.3 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: <10 to >=10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: <10 to missing
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: >=10 to no
|
0.3 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: >=10 to <10
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: missing to no
|
0 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: missing to <10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: missing to >=10
|
0.6 percent
|
|
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
Baseline to week 76: no status change
|
69.4 percent
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 52 and week 76Population: Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment.
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=160 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
The Proportion of Participants With Absence of Subretinal Fluid
Baseline
|
25.6 percent
Interval 19.1 to 33.1
|
|
The Proportion of Participants With Absence of Subretinal Fluid
Week 24
|
98.7 percent
Interval 95.4 to 99.8
|
|
The Proportion of Participants With Absence of Subretinal Fluid
Week 52
|
95.4 percent
Interval 90.8 to 98.1
|
|
The Proportion of Participants With Absence of Subretinal Fluid
Week 76
|
97.8 percent
Interval 93.7 to 99.5
|
SECONDARY outcome
Timeframe: Up to 30 days after week 76Population: Safety analysis set: included all participants who received any study drug
Outcome measures
| Measure |
Intravitreal (IVT) Aflibercept
n=162 Participants
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Any ocular TEAEs
|
90 Participants
|
|
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Severity: mild
|
39 Participants
|
|
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Severity: moderate
|
43 Participants
|
|
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Severity: severe
|
8 Participants
|
Adverse Events
Intravitreal (IVT) Aflibercept
Serious events: 32 serious events
Other events: 81 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intravitreal (IVT) Aflibercept
n=162 participants at risk
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
4/162 • Number of events 4 • Up to 30 days after week 76
|
|
Cardiac disorders
Atrial flutter
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Cardiac disorders
Cardiac failure acute
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Cardiac disorders
Mitral valve incompetence
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Cardiac disorders
Ventricular tachycardia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Amaurosis fugax
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Cataract
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Iridocyclitis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Retinal artery occlusion
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Retinal degeneration
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Retinal ischaemia
|
1.2%
2/162 • Number of events 2 • Up to 30 days after week 76
|
|
Eye disorders
Retinal vein occlusion
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Visual acuity reduced
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Eye disorders
Visual impairment
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.2%
2/162 • Number of events 2 • Up to 30 days after week 76
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Endocarditis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Lower respiratory tract infection
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Gastroenteritis viral
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Urosepsis
|
0.62%
1/162 • Number of events 2 • Up to 30 days after week 76
|
|
Infections and infestations
Pneumonia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Infections and infestations
Latent syphilis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Nervous system disorders
Dementia
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Psychiatric disorders
Delirium
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Nervous system disorders
Syncope
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Renal and urinary disorders
Acute kidney injury
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Renal and urinary disorders
Renal colic
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Reproductive system and breast disorders
Endometriosis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Vascular disorders
Deep vein thrombosis
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Vascular disorders
Haematoma
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.62%
1/162 • Number of events 1 • Up to 30 days after week 76
|
Other adverse events
| Measure |
Intravitreal (IVT) Aflibercept
n=162 participants at risk
Participants with macular edema secondary to CRVO were treated with 2 mg study drug intravitreal aflibercept over a treatment period of 76 weeks
|
|---|---|
|
Eye disorders
Macular oedema
|
7.4%
12/162 • Number of events 13 • Up to 30 days after week 76
|
|
Eye disorders
Conjunctival haemorrhage
|
11.1%
18/162 • Number of events 23 • Up to 30 days after week 76
|
|
Eye disorders
Retinal ischaemia
|
8.0%
13/162 • Number of events 16 • Up to 30 days after week 76
|
|
Eye disorders
Retinal haemorrhage
|
8.6%
14/162 • Number of events 14 • Up to 30 days after week 76
|
|
Eye disorders
Visual acuity reduced
|
16.0%
26/162 • Number of events 37 • Up to 30 days after week 76
|
|
Eye disorders
Vitreous detachment
|
5.6%
9/162 • Number of events 11 • Up to 30 days after week 76
|
|
Eye disorders
Foreign body sensation in eyes
|
5.6%
9/162 • Number of events 13 • Up to 30 days after week 76
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
26/162 • Number of events 40 • Up to 30 days after week 76
|
|
Investigations
Intraocular pressure increased
|
12.3%
20/162 • Number of events 40 • Up to 30 days after week 76
|
|
Vascular disorders
Hypertension
|
11.7%
19/162 • Number of events 25 • Up to 30 days after week 76
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60