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DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact (DA VINCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00789477
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Procedure: Laser Photocoagulation
Drug: Intravitreal Aflibercept Injection
Enrollment 221
Recruitment Details A total of 221 participants were randomized at 39 sites in the US, Canada, and Austria. After the 1 year treatment period, participants were to be followed for safety in a 6 mo. follow-up phase. The last visit for this study occurred in September, 2010.
Pre-assignment Details The study population consisted of men and women aged 18 or older with clinically significant diabetic macular edema (DME) with central involvement, and a best corrected visual acuity (BCVA) of 20/40 to 20/320 (letter score of 73 to 24) in the study eye.
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks. Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2 mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria to week 52
Period Title: Overall Study
Started 44 [1] 44 [1] 44 [1] 44 [1] 45 [1]
Participants Received Treatment 44 [2] 44 [3] 44 [3] 42 [3] 45 [3]
Completed 33 38 33 34 38
Not Completed 11 6 11 10 7
Reason Not Completed
Withdrawal by Subject             2             1             3             2             3
Protocol Violation             1             0             0             1             0
Adverse Event             3             3             1             0             0
Death             1             1             2             2             0
Lost to Follow-up             0             1             4             2             4
Lack of Efficacy             2             0             0             0             0
Other             2             0             1             3             0
[1]
randomized
[2]
safety analysis set (SAF)
[3]
SAF
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN Total
Hide Arm/Group Description Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks. Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52 Total of all reporting groups
Overall Number of Baseline Participants 44 44 44 42 45 219
Hide Baseline Analysis Population Description
Full analysis set (FAS): included all randomized patients who received any study drug, had baseline assessments, and had at least one (1) post-baseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 44 participants 42 participants 45 participants 219 participants
64.0  (8.12) 62.3  (10.70) 62.1  (10.50) 62.5  (11.49) 60.7  (8.66) 62.3  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 44 participants 42 participants 45 participants 219 participants
Female
17
  38.6%
20
  45.5%
17
  38.6%
20
  47.6%
16
  35.6%
90
  41.1%
Male
27
  61.4%
24
  54.5%
27
  61.4%
22
  52.4%
29
  64.4%
129
  58.9%
1.Primary Outcome
Title Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
Hide Description

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.

Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).

Time Frame At week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS was used for the primary efficacy analysis. It included patients as randomized.
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description:
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Intravitreal Aflibercept Injection (IAI) 0.5mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
Overall Number of Participants Analyzed 44 44 44 42 45
Mean (Standard Deviation)
Unit of Measure: letters correctly read
2.5  (16.14) 8.6  (14.64) 11.4  (8.67) 8.5  (7.50) 10.3  (7.52)
2.Secondary Outcome
Title Change in BCVA From Baseline to Week 52 - LOCF
Hide Description Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Time Frame At week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description:
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
Overall Number of Participants Analyzed 44 44 44 42 45
Mean (Standard Deviation)
Unit of Measure: letters correctly read
-1.3  (20.72) 11.0  (15.40) 13.1  (10.54) 9.7  (8.93) 12.0  (11.09)
3.Secondary Outcome
Title Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF
Hide Description Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Time Frame At week 24 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description:
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
Overall Number of Participants Analyzed 44 44 44 42 45
Measure Type: Number
Unit of Measure: participants
At week 24 9 15 14 7 12
At week 52 5 18 20 10 19
4.Secondary Outcome
Title Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF
Hide Description Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).
Time Frame At week 24 and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description:
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
Overall Number of Participants Analyzed 43 44 44 42 45
Mean (Standard Deviation)
Unit of Measure: microns
At week 24 -67.9  (135.17) -144.6  (110.65) -194.5  (143.04) -127.3  (141.78) -153.3  (132.17)
At week 52 -58.4  (177.60) -165.4  (135.72) -227.4  (148.96) -187.8  (135.01) -180.3  (124.43)
5.Secondary Outcome
Title Number of Focal Laser Treatments
Hide Description [Not Specified]
Time Frame Week 1 to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description:
Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks to week 52
Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
Overall Number of Participants Analyzed 44 44 44 42 45
Mean (Standard Deviation)
Unit of Measure: Treatments
2.5  (0.87) 0.8  (0.93) 0.5  (0.66) 0.8  (0.86) 0.7  (0.77)
Time Frame Day 1 to week 52
Adverse Event Reporting Description Safety analysis set (SAF): included all patients who received any study drug. The SAF was used for all safety and tolerability assessments. Safety analysis included patients as treated.
 
Arm/Group Title Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Hide Arm/Group Description Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks. Intravitreal Aflibercept Injection (IAI) 0.5 mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks to week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by every 8 weeks through week 52 Intravitreal Aflibercept Injection (IAI) 2mg every 4 weeks for 3 visits followed by PRN dosing according to the re-treatment criteria to week 52
All-Cause Mortality
Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/44 (22.73%)   14/44 (31.82%)   13/44 (29.55%)   12/42 (28.57%)   6/45 (13.33%) 
Blood and lymphatic system disorders           
Anaemia  0/44 (0.00%)  1/44 (2.27%)  2/44 (4.55%)  0/42 (0.00%)  0/45 (0.00%) 
Coagulopathy  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Haemorrhagic anaemia  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Cardiac disorders           
Acute coronary syndrome  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Acute myocardial infarction  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Angina pectoris  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Angina unstable  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Arteriosclerosis coronary artery  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Atrial fibrillation  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Cardiac failure acute  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Cardiac failure congestive  0/44 (0.00%)  0/44 (0.00%)  3/44 (6.82%)  1/42 (2.38%)  2/45 (4.44%) 
Coronary artery disease  0/44 (0.00%)  1/44 (2.27%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Coronary artery occlusion  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Myocardial infarction  0/44 (0.00%)  2/44 (4.55%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Sick sinus syndrome  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Silent myocardial infarction  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Wolff-Parkinson-White syndrome  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Eye disorders           
Angle closure glaucoma 1 [1]  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Corneal abrasion 1 [1]  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Cystoid macular oedema  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Diabetic retinal oedema 1 [1]  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Diabetic retinopathy  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Maculopathy  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Retinal tear  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Uveitis 1 [1]  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Visual acuity reduced  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Visual acuity reduced 1 [1]  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Vitreous adhesions  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Vitreous haemorrhage 1 [1]  3/44 (6.82%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Vitreous haemorrhage  1/44 (2.27%)  1/44 (2.27%)  1/44 (2.27%)  2/42 (4.76%)  0/45 (0.00%) 
Gastrointestinal disorders           
Diverticulum  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Gastric ulcer  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Gastrointestinal haemorrhage  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Lower gastrointestinal haemorrhage  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Nausea  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Upper gastrointestinal haemorrhage  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Varices oesophageal  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Vomiting  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
General disorders           
Chest pain  0/44 (0.00%)  0/44 (0.00%)  2/44 (4.55%)  0/42 (0.00%)  3/45 (6.67%) 
Device occlusion  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Multi-organ failure  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Non-cardiac chest pain  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Pyrexia  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Sudden death  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Infections and infestations           
Abscess  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Abscess limb  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Appendicitis  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Bronchitis  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Cellulitis  0/44 (0.00%)  3/44 (6.82%)  2/44 (4.55%)  0/42 (0.00%)  1/45 (2.22%) 
Clostridium difficile colitis  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Cystitis  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Diverticulitis  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Endophthalmitis 1 [1]  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  1/45 (2.22%) 
Gangrene  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Gastroenteritis  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Localised infection  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Osteomyelitis  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Parotitis  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Pneumonia  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Sepsis  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Staphylococcal infection  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Staphylococcal sepsis  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Subcutaneous abscess  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Injury, poisoning and procedural complications           
Joint capsule rupture  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Postoperative ileus  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Thermal burn  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Traumatic brain injury  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Investigations           
Blood pressure increased  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Liver function test abnormal  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  2/42 (4.76%)  0/45 (0.00%) 
Diabetic ketoacidosis  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Fluid overload  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Hyperglycaemia  0/44 (0.00%)  0/44 (0.00%)  2/44 (4.55%)  0/42 (0.00%)  0/45 (0.00%) 
Hyperkalaemia  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Hypoglycaemia  1/44 (2.27%)  1/44 (2.27%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Musculoskeletal and connective tissue disorders           
Lumbar spinal stenosis  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Colon cancer stage III  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Non-small cell lung cancer  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Renal cell carcinoma stage IV  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Squamous cell carcinoma of skin  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Transitional cell carcinoma  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Nervous system disorders           
Cerebral infarction  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Cerebrovascular accident  1/44 (2.27%)  1/44 (2.27%)  2/44 (4.55%)  0/42 (0.00%)  0/45 (0.00%) 
Convulsion  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Headache  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Hemiparesis  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Hepatic encephalopathy  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Sciatica  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Syncope  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  1/45 (2.22%) 
Psychiatric disorders           
Mental status changes  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Renal and urinary disorders           
Nephropathy  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Renal failure  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Renal failure acute  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Stress urinary incontinence  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Dyspnoea  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Pleural effusion  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Pulmonary embolism  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Pulmonary oedema  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Respiratory failure  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Skin and subcutaneous tissue disorders           
Skin ulcer  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Vascular disorders           
Aortic stenosis  0/44 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Deep vein thrombosis  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Hypertension  0/44 (0.00%)  0/44 (0.00%)  2/44 (4.55%)  1/42 (2.38%)  0/45 (0.00%) 
Hypertensive crisis  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Hypertensive emergency  1/44 (2.27%)  0/44 (0.00%)  1/44 (2.27%)  0/42 (0.00%)  0/45 (0.00%) 
Hypotension  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Peripheral arterial occlusive disease  1/44 (2.27%)  0/44 (0.00%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
1
Term from vocabulary, MedDRA 13.1
[1]
Study eye
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Laser Photocoagulation Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321).5Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)2PRN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/44 (45.45%)   22/44 (50.00%)   22/44 (50.00%)   26/42 (61.90%)   24/45 (53.33%) 
Blood and lymphatic system disorders           
Anaemia  2/44 (4.55%)  1/44 (2.27%)  3/44 (6.82%)  4/42 (9.52%)  5/45 (11.11%) 
Eye disorders           
Blepharitis  0/44 (0.00%)  0/44 (0.00%)  4/44 (9.09%)  0/42 (0.00%)  1/45 (2.22%) 
Blepharitis 1 [1]  0/44 (0.00%)  0/44 (0.00%)  4/44 (9.09%)  0/42 (0.00%)  1/45 (2.22%) 
Cataract  1/44 (2.27%)  2/44 (4.55%)  1/44 (2.27%)  0/42 (0.00%)  5/45 (11.11%) 
Cataract 1 [1]  2/44 (4.55%)  2/44 (4.55%)  3/44 (6.82%)  2/42 (4.76%)  5/45 (11.11%) 
Conjunctival haemorrhage  8/44 (18.18%)  12/44 (27.27%)  7/44 (15.91%)  15/42 (35.71%)  13/45 (28.89%) 
Diabetic retinal oedema  0/44 (0.00%)  4/44 (9.09%)  3/44 (6.82%)  0/42 (0.00%)  4/45 (8.89%) 
Diabetic retinal oedema 1 [1]  0/44 (0.00%)  1/44 (2.27%)  3/44 (6.82%)  1/42 (2.38%)  3/45 (6.67%) 
Eye pain  3/44 (6.82%)  2/44 (4.55%)  0/44 (0.00%)  1/42 (2.38%)  0/45 (0.00%) 
Eye pain 1 [1]  2/44 (4.55%)  6/44 (13.64%)  5/44 (11.36%)  6/42 (14.29%)  7/45 (15.56%) 
Foreign body sensation in eye 1 [1]  0/44 (0.00%)  1/44 (2.27%)  1/44 (2.27%)  1/42 (2.38%)  3/45 (6.67%) 
Macular oedema  3/44 (6.82%)  1/44 (2.27%)  0/44 (0.00%)  0/42 (0.00%)  0/45 (0.00%) 
Maculopathy 1 [1]  2/44 (4.55%)  2/44 (4.55%)  1/44 (2.27%)  4/42 (9.52%)  3/45 (6.67%) 
Ocular hyperaemia 1 [1]  2/44 (4.55%)  5/44 (11.36%)  2/44 (4.55%)  3/42 (7.14%)  3/45 (6.67%) 
Posterior capsule opacification  3/44 (6.82%)  1/44 (2.27%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Punctate keratitis 1 [1]  1/44 (2.27%)  1/44 (2.27%)  0/44 (0.00%)  3/42 (7.14%)  0/45 (0.00%) 
Retinal aneurysm  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  3/42 (7.14%)  1/45 (2.22%) 
Retinal haemorrhage  3/44 (6.82%)  1/44 (2.27%)  1/44 (2.27%)  3/42 (7.14%)  5/45 (11.11%) 
Retinal haemorrhage 1 [1]  2/44 (4.55%)  0/44 (0.00%)  3/44 (6.82%)  1/42 (2.38%)  4/45 (8.89%) 
Retinal aneurysm 1 [1]  1/44 (2.27%)  3/44 (6.82%)  0/44 (0.00%)  2/42 (4.76%)  2/45 (4.44%) 
Retinal neovascularisation  1/44 (2.27%)  0/44 (0.00%)  2/44 (4.55%)  1/42 (2.38%)  3/45 (6.67%) 
Retinal exudates 1 [1]  1/44 (2.27%)  4/44 (9.09%)  1/44 (2.27%)  2/42 (4.76%)  3/45 (6.67%) 
Vision blurred 1 [1]  1/44 (2.27%)  4/44 (9.09%)  0/44 (0.00%)  0/42 (0.00%)  2/45 (4.44%) 
Vitreous detachment  3/44 (6.82%)  2/44 (4.55%)  1/44 (2.27%)  4/42 (9.52%)  0/45 (0.00%) 
Vitreous detachment 1 [1]  5/44 (11.36%)  3/44 (6.82%)  3/44 (6.82%)  3/42 (7.14%)  0/45 (0.00%) 
Vitreous floaters  1/44 (2.27%)  0/44 (0.00%)  3/44 (6.82%)  2/42 (4.76%)  0/45 (0.00%) 
Vitreous floaters 1 [1]  2/44 (4.55%)  5/44 (11.36%)  3/44 (6.82%)  2/42 (4.76%)  2/45 (4.44%) 
Vitreous haemorrhage  5/44 (11.36%)  3/44 (6.82%)  5/44 (11.36%)  4/42 (9.52%)  3/45 (6.67%) 
Vitreous haemorrhage 1 [1]  5/44 (11.36%)  0/44 (0.00%)  2/44 (4.55%)  1/42 (2.38%)  1/45 (2.22%) 
Gastrointestinal disorders           
Nausea  1/44 (2.27%)  2/44 (4.55%)  3/44 (6.82%)  4/42 (9.52%)  4/45 (8.89%) 
General disorders           
Oedema peripheral  3/44 (6.82%)  1/44 (2.27%)  1/44 (2.27%)  2/42 (4.76%)  2/45 (4.44%) 
Infections and infestations           
Bronchitis  1/44 (2.27%)  3/44 (6.82%)  2/44 (4.55%)  0/42 (0.00%)  2/45 (4.44%) 
Nasopharyngitis  4/44 (9.09%)  4/44 (9.09%)  3/44 (6.82%)  1/42 (2.38%)  3/45 (6.67%) 
Injury, poisoning and procedural complications           
Corneal abrasion 1 [1]  0/44 (0.00%)  0/44 (0.00%)  2/44 (4.55%)  2/42 (4.76%)  3/45 (6.67%) 
Investigations           
Blood glucose increased  1/44 (2.27%)  4/44 (9.09%)  3/44 (6.82%)  6/42 (14.29%)  6/45 (13.33%) 
Blood potassium increased  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  3/42 (7.14%)  3/45 (6.67%) 
Blood pressure increased  1/44 (2.27%)  1/44 (2.27%)  4/44 (9.09%)  1/42 (2.38%)  1/45 (2.22%) 
Blood urine present  0/44 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  1/42 (2.38%)  3/45 (6.67%) 
Glucose urine present  1/44 (2.27%)  1/44 (2.27%)  0/44 (0.00%)  3/42 (7.14%)  4/45 (8.89%) 
Glycosylated haemoglobin increased  2/44 (4.55%)  6/44 (13.64%)  5/44 (11.36%)  5/42 (11.90%)  2/45 (4.44%) 
Haematocrit decreased  2/44 (4.55%)  2/44 (4.55%)  4/44 (9.09%)  0/42 (0.00%)  0/45 (0.00%) 
Haemoglobin decreased  2/44 (4.55%)  2/44 (4.55%)  3/44 (6.82%)  0/42 (0.00%)  0/45 (0.00%) 
Intraocular pressure increased 1 [1]  1/44 (2.27%)  6/44 (13.64%)  6/44 (13.64%)  5/42 (11.90%)  2/45 (4.44%) 
Protein urine present  2/44 (4.55%)  1/44 (2.27%)  1/44 (2.27%)  4/42 (9.52%)  3/45 (6.67%) 
Red blood cell count decreased  0/44 (0.00%)  1/44 (2.27%)  3/44 (6.82%)  0/42 (0.00%)  1/45 (2.22%) 
Metabolism and nutrition disorders           
Hypercholesterolaemia  1/44 (2.27%)  1/44 (2.27%)  3/44 (6.82%)  3/42 (7.14%)  1/45 (2.22%) 
Nervous system disorders           
Headache  2/44 (4.55%)  0/44 (0.00%)  2/44 (4.55%)  3/42 (7.14%)  2/45 (4.44%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  3/42 (7.14%)  1/45 (2.22%) 
Oropharyngeal pain  3/44 (6.82%)  1/44 (2.27%)  1/44 (2.27%)  1/42 (2.38%)  0/45 (0.00%) 
Vascular disorders           
Hypertension  5/44 (11.36%)  5/44 (11.36%)  5/44 (11.36%)  6/42 (14.29%)  5/45 (11.11%) 
1
Term from vocabulary, MedDRA 13.1
[1]
Study eye
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Not less than 45 days prior to submission of a publication (S)ponsor shall be provided with a copy of the publication. The parties shall discuss any comments submitted by S regarding content, & Institution & PI shall delete any confidential information that S requests to be deleted. In addition, since the study is being conducted at multiple sites, parties agreed that publication of results shall be made only as part of a publication of the results obtained by all sites performing the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Management
Organization: Regeneron
Phone: 9148475385
EMail: clinicaltrials@regeneron.com
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00789477    
Other Study ID Numbers: VGFT-OD-0706
First Submitted: November 7, 2008
First Posted: November 11, 2008
Results First Submitted: August 28, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014