Trial Outcomes & Findings for Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD) (NCT NCT00964795)
NCT ID: NCT00964795
Last Updated: 2015-03-23
Results Overview
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
Baseline (day 1) through end of treatment (Week 180)
Results posted on
2015-03-23
Participant Flow
After informed consent was obtained, the 323 participants who completed the parent study, VGFT-OD-0605 (NCT00509795), and met the protocol eligibility criteria, were enrolled at 71 clinical sites in the US \& Canada. The first visit occurred concurrently with the last visit in the parent study. The last participant entered this study on 18-May-2011.
Intravitreal Aflibercept Injection \[commercially known EYLEA® (aflibercept) Injection\] was approved in the US for treatment of neovascular ("wet") age-related macular degeneration (AMD) as the study was ongoing. For collection of long-term safety and best corrected visual acuity data on EYLEA®, the study was extended in the US from 30 to 45 months.
Participant milestones
| Measure |
Open-label Intravitreal Aflibercept Injection
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Overall Study
STARTED
|
323
|
|
Overall Study
Number of Participants Treated
|
320
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
307
|
Reasons for withdrawal
| Measure |
Open-label Intravitreal Aflibercept Injection
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
79
|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
14
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Termination of Study by Sponsor
|
169
|
|
Overall Study
Unwilling to sign ICF for amendment 4
|
3
|
|
Overall Study
Other
|
23
|
Baseline Characteristics
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 Participants
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Age, Continuous
|
79 years
STANDARD_DEVIATION 7.83 • n=93 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline (day 1) through end of treatment (Week 180)The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Outcome measures
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 Participants
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Number of participants with any TEAE
|
290 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any ocular TEAE
|
239 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any ocular TEAE: Study eye
|
204 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any ocular TEAE: Fellow eye
|
169 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any non-ocular TEAE
|
232 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any serious TEAE
|
105 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Discontinuation of study due to AE
|
12 participants
|
|
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
Any Death due to TEAE
|
17 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 116The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116. (mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).
Outcome measures
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 Participants
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Change in BCVA Letter Score (mLOCF)
|
-2.7 letters correctly read
Standard Deviation 12.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through end of treatment (Week 180)Treatment Duration = (last dose date - first dose date + 28)/7
Outcome measures
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 Participants
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Summary of Treatment Duration (Weeks)
|
110.4 weeks
Standard Deviation 42.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through end of treatment (Week 180)Study Duration = (last visit/ discontinuation date - first dose date + 28)/7
Outcome measures
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 Participants
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Summary of Study Duration (Weeks)
|
116.9 weeks
Standard Deviation 44.3
|
Adverse Events
Open-label Intravitreal Aflibercept Injection
Serious events: 105 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 participants at risk
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.31%
1/323
|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
2/323
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.31%
1/323
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.31%
1/323
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.31%
1/323
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
5/323
|
|
Cardiac disorders
Angina Pectoris
|
0.93%
3/323
|
|
Cardiac disorders
Arrhythmia
|
0.62%
2/323
|
|
Cardiac disorders
Atrial Fibrillation
|
3.7%
12/323
|
|
Cardiac disorders
Bundle Branch Block Right
|
0.31%
1/323
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
4/323
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.93%
3/323
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.93%
3/323
|
|
Cardiac disorders
Cardiogenic Shock
|
0.31%
1/323
|
|
Cardiac disorders
Cardiomyopathy
|
0.31%
1/323
|
|
Cardiac disorders
Coronary Artery Disease
|
1.2%
4/323
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
4/323
|
|
Cardiac disorders
Myocardial Rupture
|
0.31%
1/323
|
|
Cardiac disorders
Pericarditis
|
0.31%
1/323
|
|
Cardiac disorders
Tachycardia
|
0.31%
1/323
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.31%
1/323
|
|
Gastrointestinal disorders
Appendix Disorder
|
0.31%
1/323
|
|
Gastrointestinal disorders
Colitis
|
0.31%
1/323
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.31%
1/323
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
3/323
|
|
Gastrointestinal disorders
Dysphagia
|
0.31%
1/323
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia Haemorrhagic
|
0.31%
1/323
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.31%
1/323
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/323
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.31%
1/323
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.31%
1/323
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.31%
1/323
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.31%
1/323
|
|
Gastrointestinal disorders
Nausea
|
0.31%
1/323
|
|
Gastrointestinal disorders
Pancreatitis
|
0.62%
2/323
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
3/323
|
|
General disorders
Asthenia
|
0.31%
1/323
|
|
General disorders
Chest Pain
|
0.31%
1/323
|
|
General disorders
Device Dislocation
|
0.31%
1/323
|
|
General disorders
Multi-Organ Failure
|
0.31%
1/323
|
|
General disorders
Non-Cardiac Chest Pain
|
0.31%
1/323
|
|
Hepatobiliary disorders
Biliary Dyskinesia
|
0.31%
1/323
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.31%
1/323
|
|
Hepatobiliary disorders
Hepatic Haemorrhage
|
0.31%
1/323
|
|
Immune system disorders
Anaphylactic Reaction
|
0.31%
1/323
|
|
Infections and infestations
Abdominal Abscess
|
0.31%
1/323
|
|
Infections and infestations
Abscess
|
0.31%
1/323
|
|
Infections and infestations
Appendicitis
|
0.31%
1/323
|
|
Infections and infestations
Bronchitis
|
0.31%
1/323
|
|
Infections and infestations
Bronchitis Viral
|
0.31%
1/323
|
|
Infections and infestations
Cellulitis
|
0.93%
3/323
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.31%
1/323
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.31%
1/323
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/323
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.31%
1/323
|
|
Infections and infestations
Gastroenteritis Viral
|
0.31%
1/323
|
|
Infections and infestations
Pericolic Abscess
|
0.31%
1/323
|
|
Infections and infestations
Peritonitis
|
0.31%
1/323
|
|
Infections and infestations
Pneumonia
|
1.5%
5/323
|
|
Infections and infestations
Pneumonia Bacterial
|
0.31%
1/323
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.31%
1/323
|
|
Infections and infestations
Pneumonia Viral
|
0.31%
1/323
|
|
Infections and infestations
Pyelonephritis Acute
|
0.31%
1/323
|
|
Infections and infestations
Sepsis
|
0.93%
3/323
|
|
Infections and infestations
Septic Shock
|
0.31%
1/323
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
5/323
|
|
Infections and infestations
Urosepsis
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Accident
|
0.62%
2/323
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.93%
3/323
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
16/323
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.62%
2/323
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.62%
2/323
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.93%
3/323
|
|
Injury, poisoning and procedural complications
Pancreatic Leak
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Splenic Rupture
|
0.62%
2/323
|
|
Investigations
Blood Pressure Increased
|
0.31%
1/323
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
4/323
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.31%
1/323
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/323
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
1/323
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
1/323
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.31%
1/323
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.31%
1/323
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.31%
1/323
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.31%
1/323
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
4/323
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic Fracture
|
0.31%
1/323
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.62%
2/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Cancer
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.62%
2/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Leukaemia
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myelomonocytic Leukaemia
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Squamous Cell Carcinoma
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.62%
2/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.62%
2/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.31%
1/323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Lung
|
0.31%
1/323
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.31%
1/323
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.31%
1/323
|
|
Nervous system disorders
Cerebral Infarction
|
0.31%
1/323
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.5%
5/323
|
|
Nervous system disorders
Convulsion
|
0.31%
1/323
|
|
Nervous system disorders
Embolic Stroke
|
0.31%
1/323
|
|
Nervous system disorders
Facial Neuralgia
|
0.31%
1/323
|
|
Nervous system disorders
Hemiplegia
|
0.31%
1/323
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.31%
1/323
|
|
Nervous system disorders
Intracranial Haematoma
|
0.31%
1/323
|
|
Nervous system disorders
Ischaemic Stroke
|
0.31%
1/323
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.31%
1/323
|
|
Nervous system disorders
Syncope
|
2.5%
8/323
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.2%
4/323
|
|
Psychiatric disorders
Major Depression
|
0.31%
1/323
|
|
Psychiatric disorders
Mental Status Changes
|
0.93%
3/323
|
|
Psychiatric disorders
Psychotic Disorder
|
0.31%
1/323
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.31%
1/323
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/323
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.31%
1/323
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.2%
4/323
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.31%
1/323
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.31%
1/323
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.2%
4/323
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.31%
1/323
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.62%
2/323
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.31%
1/323
|
|
Skin and subcutaneous tissue disorders
Perivascular Dermatitis
|
0.31%
1/323
|
|
Surgical and medical procedures
Colectomy
|
0.31%
1/323
|
|
Surgical and medical procedures
Medical Device Removal
|
0.31%
1/323
|
|
Vascular disorders
Hypertension
|
0.31%
1/323
|
|
Eye disorders
Retinal Haemorrhage
|
0.62%
2/323
|
|
Eye disorders
Angle Closure Glaucoma
|
0.31%
1/323
|
|
Eye disorders
Cataract
|
0.31%
1/323
|
|
Eye disorders
Glaucoma
|
0.31%
1/323
|
|
Eye disorders
Retinal Oedema
|
0.31%
1/323
|
|
Eye disorders
Visual Acuity Reduced
|
0.31%
1/323
|
|
Infections and infestations
Endophthalmitis
|
0.93%
3/323
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.31%
1/323
|
|
Investigations
Intraocular Pressure Increased
|
0.31%
1/323
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.62%
2/323
|
Other adverse events
| Measure |
Open-label Intravitreal Aflibercept Injection
n=323 participants at risk
Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
6.8%
22/323
|
|
Infections and infestations
Bronchitis
|
5.9%
19/323
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
22/323
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.2%
20/323
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
23/323
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
17/323
|
|
Vascular disorders
Hypertension
|
9.0%
29/323
|
|
Eye disorders
Age-Related Macular Degeneration
|
9.3%
30/323
|
|
Eye disorders
Retinal Haemorrhage
|
10.5%
34/323
|
|
Eye disorders
Cataract
|
5.3%
17/323
|
|
Eye disorders
Conjunctival Haemorrhage
|
9.3%
30/323
|
|
Eye disorders
Posterior Capsule Opacification
|
5.6%
18/323
|
|
Eye disorders
Retinal Detachment
|
5.3%
17/323
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator (PI) may publish results provided a copy of oral/ written publication is received by sponsor at least 45 days in advance for review \& comment. If the parties disagree, PI agrees to meet with sponsor prior to submission to resolve any disagreement. Sponsor reserves the right to remove confidential information from such submission. It is also agreed that publication of results shall be made only as part of a publication of the results obtained by all sites performing the study.
- Publication restrictions are in place
Restriction type: OTHER