Trial Outcomes & Findings for Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD (NCT NCT00527423)
NCT ID: NCT00527423
Last Updated: 2013-06-12
Results Overview
Number of participants with AEs summarized by category
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Baseline of this study to Wk 152
Results posted on
2013-06-12
Participant Flow
This study was conducted at 35 sites in the United States that participated in the Phase 1 and Phase 2 studies VGFT OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). The recruitment period occurred between 19 Oct 2007 and 29 Oct 2008.
One hundred fifty seven participants were eligible if they had neovascular Age-related Macular Degeneration (AMD) and completed dosing in the Phase 1 and Phase 2 studies VGFT-OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). For each subject, only one eye was designated as the study eye.
Participant milestones
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
157
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
OTHER
|
4
|
|
Overall Study
Death
|
9
|
Baseline Characteristics
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 Participants
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Age Continuous
|
77.9 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline Best Corrected Visual Acuity (BCVA)
|
61.3 scores on a scale
STANDARD_DEVIATION 15.35 • n=5 Participants
|
|
Baseline Intraocular Pressure
|
14.5 mmHg
STANDARD_DEVIATION 3.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline of this study to Wk 152Number of participants with AEs summarized by category
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 Participants
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AE)
Number of participants with any AE
|
154 participants
|
|
Number of Participants With Adverse Events (AE)
Any ocular AE (Study eye and Fellow eye)
|
138 participants
|
|
Number of Participants With Adverse Events (AE)
Any non ocular AE
|
151 participants
|
|
Number of Participants With Adverse Events (AE)
Any treatment related AE (Ocular and non ocular)
|
5 participants
|
|
Number of Participants With Adverse Events (AE)
Any SAE
|
72 participants
|
|
Number of Participants With Adverse Events (AE)
Any AEs leading to withdrawal from study
|
5 participants
|
|
Number of Participants With Adverse Events (AE)
Any Death due to AE
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline of this study to Wk 152Population: A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.
Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 Participants
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Frequency (Number of Injections)
|
6.0 Injections
Interval 0.0 to 26.0
|
SECONDARY outcome
Timeframe: Baseline of original study to Wk 156Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 Participants
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
|
4.1 letters read
Standard Deviation 17.71
|
Adverse Events
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
Serious events: 72 serious events
Other events: 149 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 participants at risk
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
4/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
3.2%
5/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Vascular disorders
Hypertension
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Vascular disorders
Hypotension
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Vascular disorders
Orthostatic hypotension
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Endocrine disorders
Goitre
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Lens dislocation
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Retinal oedema
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Diarrhoea
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Eructation
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
General disorders
Chest pain
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
General disorders
Gait disturbance
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
General disorders
Metaplasia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Angina pectoris
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
7/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Atrioventricular block
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Bradycardia
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Cardiac arrest
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Coronary artery disease
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Coronary artery stenosis
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Cardiac disorders
Pericarditis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Immune system disorders
Sarcoidosis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Bronchitis
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Cellulitis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Clostridium difficile colitis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Enteritis infectious
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Gastroenteritis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Pneumonia
|
3.2%
5/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Sepsis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Viral infection
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Accident
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Concussion
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
7/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Head injury
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Investigations
Intraocular pressure increased
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Renal and urinary disorders
Haematuria
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Renal and urinary disorders
Renal failure
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Hepatobiliary disorders
Bile duct stone
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Hepatobiliary disorders
Cholecystitis
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
3/157 • Baseline of this study to Wk 156
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
4/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Carotid artery stenosis
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Dementia
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Dizziness
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Headache
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Hypoaesthesia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Lacunar infarction
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Presyncope
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Syncope
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Transient ischaemic attack
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Psychiatric disorders
Hallucination
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Psychiatric disorders
Mental disorder
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Psychiatric disorders
Mental status changes
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Visual acuity reduced
|
2.5%
4/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Retinal haemorrhage
|
1.3%
2/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Cataract
|
0.64%
1/157 • Baseline of this study to Wk 156
|
Other adverse events
| Measure |
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg
n=157 participants at risk
The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or "as needed" dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
15/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.6%
12/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
12/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Vascular disorders
Hypertension
|
16.6%
26/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Age-related macular degeneration
|
11.5%
18/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Blepharitis
|
8.3%
13/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Cataract
|
13.4%
21/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Cataract nuclear
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Conjunctival haemorrhage
|
7.6%
12/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Dry eye
|
6.4%
10/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Eye pain
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Eye pruritus
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Posterior capsule opacification
|
6.4%
10/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Retinal haemorrhage
|
12.1%
19/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Visual acuity reduced
|
8.3%
13/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Vitreous detachment
|
7.0%
11/157 • Baseline of this study to Wk 156
|
|
Eye disorders
Vitreous floaters
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Constipation
|
7.6%
12/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
16/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Gastrointestinal disorders
Nausea
|
8.9%
14/157 • Baseline of this study to Wk 156
|
|
Immune system disorders
Seasonal allergy
|
9.6%
15/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Bronchitis
|
10.8%
17/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Influenza
|
6.4%
10/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Nasopharyngitis
|
16.6%
26/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Sinusitis
|
10.2%
16/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Upper respiratory tract infection
|
15.3%
24/157 • Baseline of this study to Wk 156
|
|
Infections and infestations
Urinary tract infection
|
15.9%
25/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Contusion
|
6.4%
10/157 • Baseline of this study to Wk 156
|
|
Injury, poisoning and procedural complications
Fall
|
18.5%
29/157 • Baseline of this study to Wk 156
|
|
Investigations
Blood glucose increased
|
8.3%
13/157 • Baseline of this study to Wk 156
|
|
Investigations
Blood pressure increased
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Investigations
Protein urine present
|
8.3%
13/157 • Baseline of this study to Wk 156
|
|
Investigations
White blood cell count increased
|
7.6%
12/157 • Baseline of this study to Wk 156
|
|
Investigations
White blood cells urine positive
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.7%
9/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Dizziness
|
6.4%
10/157 • Baseline of this study to Wk 156
|
|
Nervous system disorders
Headache
|
5.1%
8/157 • Baseline of this study to Wk 156
|
|
Psychiatric disorders
Depression
|
8.9%
14/157 • Baseline of this study to Wk 156
|
|
Psychiatric disorders
Insomnia
|
8.3%
13/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
14/157 • Baseline of this study to Wk 156
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
9/157 • Baseline of this study to Wk 156
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish study results until Sponsor can review and comment. Sponsor can also remove confidential or proprietary information.
- Publication restrictions are in place
Restriction type: OTHER