Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00320788
Collaborator
Bayer (Industry)
159
18
5
28
8.8
0.3
Study Details
Study Description
Brief Summary
This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.
The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.
After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.
Study Design
Study Type:
Interventional
Actual Enrollment
:
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
Study Start Date
:
Apr 1, 2006
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
|
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
|
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
|
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
|
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
| Experimental: aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12
|
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Change of CR/LT From Baseline at Week 12 [Baseline and at Week 12]
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Secondary Outcome Measures
- Mean Percent Change of CR/LT From Baseline at Week 12 [Baseline and at Week 12]
CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
- Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12 [Baseline and at week 12]
Defined 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
- Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12 [At Week 12]
Defined 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subfoveal CNV secondary to AMD.
-
Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
-
Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.
Exclusion Criteria:
-
History of any vitreous hemorrhage within 4 weeks prior to Day 1.
-
Aphakia.
-
Significant subfoveal atrophy or scarring.
-
Prior treatment with the following in the study eye:
-
Subfoveal thermal laser therapy.
-
Submacular surgery or other surgical intervention for the treatment of AMD.
-
Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
-
Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
-
Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
-
Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
-
Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
-
Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
-
Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Associated Retina Consultants | Phoenix | Arizona | United States | 85020 |
| 2 | Retina Centers, PC | Tucson | Arizona | United States | 85704 |
| 3 | Retina Vitreous Associates Medical Group | Beverly Hills | California | United States | 90211 |
| 4 | Loma Linda University Health Care | Loma Linda | California | United States | 92354 |
| 5 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
| 6 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 7 | Midwest Eye Institute | Indianapolis | Indiana | United States | 46280 |
| 8 | Johns Hopkins Hospital School of Medicine | Baltimore | Maryland | United States | 21287 |
| 9 | Ophthalmic Consultants of Boston | Boston | Massachusetts | United States | 02114 |
| 10 | New England Retina Consultants PC | West Springfield | Massachusetts | United States | 10189 |
| 11 | Charlotte Eye, Ear, Nose & Throat Asssociates | Charlotte | North Carolina | United States | 28210 |
| 12 | Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 13 | Retina Northwest PC | Portland | Oregon | United States | 97210 |
| 14 | Retina Diagnostic and Treatment Assoc., LLC | Philadelphia | Pennsylvania | United States | 19107 |
| 15 | Black Hills Regional Eye Institute | Rapid City | South Dakota | United States | 57701 |
| 16 | Retina-Vitreous Associates, P.C. | Nashville | Tennessee | United States | 37203 |
| 17 | Vitreoretinal Consultants Scurlock Tower Texas Medical Center | Houston | Texas | United States | 77030 |
| 18 | Medical Center Ophthamology | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Bayer
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration.
- The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.
Publications
None provided.Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00320788
Other Study ID Numbers:
- VGFT-OD-0508
First Posted:
May 3, 2006
Last Update Posted:
Mar 1, 2012
Last Verified:
Jan 1, 2012
Keywords provided by Regeneron Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 29 study sites in the United States. Recruitment period: May 2006 to April 2007. |
|---|---|
| Pre-assignment Detail | A total of 301 participants were screened; 159 participants were randomized; 157 participants were included in both the Safety Analysis Set (SAF) and the Full Analysis Set (FAS) as all received study treatment, had baseline assessments and at least 1 post-baseline assessment. |
| Arm/Group Title | Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4 | Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12 | Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4 | Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12 | Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12 |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12. |
| Period Title: Overall Study | |||||
| STARTED | 32 | 32 | 32 | 32 | 31 |
| Participants Received Treatment (SAF) | 32 | 32 | 31 | 31 | 31 |
| COMPLETED | 26 | 26 | 29 | 27 | 26 |
| NOT COMPLETED | 6 | 6 | 3 | 5 | 5 |
Baseline Characteristics
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | Total of all reporting groups |
| Overall Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
79.6
(7.56)
|
78.5
(10.12)
|
74.9
(7.63)
|
79.6
(8.91)
|
78.3
(5.97)
|
78.2
(8.25)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
17
(0)
53.1%
|
25
(0)
78.1%
|
20
(0)
64.5%
|
16
(0)
51.6%
|
20
(0)
64.5%
|
98
62.4%
|
| Male |
15
(0)
46.9%
|
7
(0)
21.9%
|
11
(0)
35.5%
|
15
(0)
48.4%
|
11
(0)
35.5%
|
59
37.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
0
(0)
0%
|
1
(0)
3.1%
|
2
(0)
6.5%
|
1
(0)
3.2%
|
0
(0)
0%
|
4
2.5%
|
| Not Hispanic or Latino |
32
(0)
100%
|
31
(0)
96.9%
|
29
(0)
93.5%
|
30
(0)
96.8%
|
31
(0)
100%
|
153
97.5%
|
| Unknown or Not Reported |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
(0)
0%
|
0
(0)
0%
|
1
(0)
3.2%
|
0
(0)
0%
|
0
(0)
0%
|
1
0.6%
|
| Asian |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| Black or African American |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| White |
32
(0)
100%
|
32
(0)
100%
|
30
(0)
96.8%
|
31
(0)
100%
|
31
(0)
100%
|
156
99.4%
|
| More than one race |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| Unknown or Not Reported |
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
(0)
0%
|
0
0%
|
| Central Retinal/Lesion Thickness (CR/LT) (µm) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [µm] |
442.2
(109.81)
|
442.6
(136.60)
|
453.3
(143.93)
|
447.0
(119.11)
|
497.5
(191.17)
|
456.4
(142.41)
|
| Best Corrected Visual Acuity (BCVA) (letters read) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [letters read] |
54.1
(13.77)
|
55.6
(11.75)
|
57.9
(12.02)
|
57.2
(10.47)
|
53.0
(14.52)
|
55.5
(12.57)
|
Outcome Measures
| Title | Mean Change of CR/LT From Baseline at Week 12 |
|---|---|
| Description | CR/LT measured in micrometers (µm); lower individual values represent better outcomes. |
| Time Frame | Baseline and at Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF) |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Mean (Standard Deviation) [μm] |
-153.5
(113.30)
|
-75.6
(110.64)
|
-169.2
(138.46)
|
-56.3
(133.05)
|
-139.8
(228.59)
|
-118.8
(155.31)
|
| Title | Mean Percent Change of CR/LT From Baseline at Week 12 |
|---|---|
| Description | CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome |
| Time Frame | Baseline and at Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS used for analysis, LOCF |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Mean (Standard Deviation) [percent change] |
-32.4
(18.92)
|
-15.2
(22.52)
|
-33.2
(19.56)
|
-10.3
(25.49)
|
-21.1
(31.56)
|
-22.5
(25.41)
|
| Title | Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12 |
|---|---|
| Description | Defined 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 |
| Time Frame | Baseline and at week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS used for analysis, LOCF |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Mean (Standard Deviation) [letters read] |
8.8
(9.20)
|
3.8
(11.55)
|
8.3
(10.14)
|
5.2
(8.46)
|
2.6
(8.72)
|
5.7
(9.87)
|
| Title | Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12 |
|---|---|
| Description | Defined 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 |
| Time Frame | At Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS used for analysis, LOCF |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Number [percentage of participants] |
18.8
(0)
58.8%
|
21.9
(0)
68.4%
|
25.8
(0)
83.2%
|
16.1
(0)
51.9%
|
9.7
(0)
31.3%
|
18.5
(0)
11.8%
|
| Title | Mean Change of CR/LT From Baseline at Week 16 |
|---|---|
| Description | CR/LT measured in micrometers (µm); lower individual values represent better outcomes |
| Time Frame | Baseline and at Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS used for analysis, LOCF |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Mean (Standard Deviation) [µm] |
-163.3
(108.13)
|
-139.6
(126.41)
|
-182.7
(146.75)
|
-107.4
(112.22)
|
-208.6
(202.07)
|
-160.2
(145.34)
|
| Title | Mean Change in BCVA as Measured by ETDRS From Baseline at Week 16 |
|---|---|
| Description | Defined 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 |
| Time Frame | Baseline and at Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS used for analysis, LOCF |
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | |
| Measure Participants | 32 | 32 | 31 | 31 | 31 | 157 |
| Mean (Standard Deviation) [letters read] |
9.3
(9.92)
|
5.6
(12.24)
|
10.0
(9.76)
|
4.3
(10.01)
|
3.9
(9.92)
|
6.6
(10.60)
|
Adverse Events
| Time Frame | Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety was assessed through reported AEs, clinical laboratory test results, vital signs, and ophthalmic examinations | |||||||||
| Arm/Group Title | Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | |||||
| Arm/Group Description | Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12. | Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12. | Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12. | |||||
All Cause Mortality |
||||||||||
| Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/ (NaN) | 5/ (NaN) | 10/ (NaN) | 7/ (NaN) | 2/ (NaN) | |||||
| Cardiac disorders | ||||||||||
| ANGINA PECTORIS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| ATRIAL FIBRILLATION | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| ATRIOVENTRICULAR BLOCK COMPLETE | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| BRADYCARDIA | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| CARDIAC FAILURE CONGESTIVE | 1/32 (3.1%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| CORONARY ARTERY DISEASE | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| Eye disorders | ||||||||||
| RETINAL DETACHMENT | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| VISUAL ACUITY REDUCED | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| UVEITIS | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| DYSKINESIA OESOPHAGEAL | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| INTESTINAL OBSTRUCTION | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| SMALL INTESTINAL OBSTRUCTION | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| VOLVULUS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| General disorders | ||||||||||
| ASTHENIA | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| NON-CARDIAC CHEST PAIN | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Infections and infestations | ||||||||||
| BRONCHITIS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| CELLULITIS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| GASTROENTERITIS | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| PNEUMONIA | 2/32 (6.3%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| URINARY TRACT INFECTION | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| FALL | 1/32 (3.1%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| HIP FRACTURE | 0/32 (0%) | 1/32 (3.1%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| SKIN LACERATION | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| SYNOVIAL RUPTURE | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Investigations | ||||||||||
| INTRAOCULAR PRESSURE INCREASED | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| BACK PAIN | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| OSTEOARTHRITIS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| SPINAL OSTEOARTHRITIS | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| BRAIN NEOPLASM MALIGNANT | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| COLON CANCER | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| METASTASES TO LUNG | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| NON-HODGKIN'S LYMPHOMA | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| PANCREATIC CARCINOMA | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| SQUAMOUS CELL CARCINOMA | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| THYROID NEOPLASM | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| TRANSITIONAL CELL CARCINOMA | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| Nervous system disorders | ||||||||||
| CAROTID ARTERY OCCLUSION | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| CEREBROVASCULAR ACCIDENT | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| COORDINATION ABNORMAL | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| DYSARTHRIA | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| SPINAL CORD DISORDER | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| TRANSIENT ISCHAEMIC ATTACK | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| RENAL FAILURE | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| STRESS INCONTINENCE | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| URINARY RETENTION | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| PNEUMONIA ASPIRATION | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| PULMONARY EMBOLISM | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| PULMONARY HYPERTENSION | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| Surgical and medical procedures | ||||||||||
| PILONIDAL SINUS REPAIR | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Vascular disorders | ||||||||||
| DEEP VEIN THROMBOSIS | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Aflibercept Injection 0.5mg q4 | Aflibercept Injection 0.5mg q12 | Aflibercept Injection 2.0mg q4 | Aflibercept Injection 2.0mg q12 | Aflibercept Injection 4.0mg q12 | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/ (NaN) | 25/ (NaN) | 27/ (NaN) | 22/ (NaN) | 22/ (NaN) | |||||
| Blood and lymphatic system disorders | ||||||||||
| ANAEMIA | 0/32 (0%) | 1/32 (3.1%) | 3/31 (9.7%) | 0/31 (0%) | 0/31 (0%) | |||||
| Cardiac disorders | ||||||||||
| ANGINA PECTORIS | 2/32 (6.3%) | 0/32 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| BRADYCARDIA | 1/32 (3.1%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| Eye disorders | ||||||||||
| BLEPHARITIS | 2/32 (6.3%) | 0/32 (0%) | 2/31 (6.5%) | 3/31 (9.7%) | 1/31 (3.2%) | |||||
| CATARACT | 0/32 (0%) | 1/32 (3.1%) | 1/31 (3.2%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| CATARACT NUCLEAR | 3/32 (9.4%) | 0/32 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| CATARACT SUBCAPSULAR | 0/32 (0%) | 2/32 (6.3%) | 0/31 (0%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| CHOROIDAL NEOVASCULARISATION | 0/32 (0%) | 1/32 (3.1%) | 2/31 (6.5%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| CONJUNCTIVAL HAEMORRHAGE | 2/32 (6.3%) | 0/32 (0%) | 2/31 (6.5%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| DETACHMENT OF RETINAL PIGMENT EPITHELIUM | 2/32 (6.3%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| DRY EYE | 1/32 (3.1%) | 0/32 (0%) | 1/31 (3.2%) | 2/31 (6.5%) | 0/31 (0%) | |||||
| LACRIMATION INCREASED | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| REFRACTION DISORDER | 1/32 (3.1%) | 4/32 (12.5%) | 1/31 (3.2%) | 1/31 (3.2%) | 3/31 (9.7%) | |||||
| RETINAL HAEMORRHAGE | 0/32 (0%) | 2/32 (6.3%) | 1/31 (3.2%) | 3/31 (9.7%) | 0/31 (0%) | |||||
| RETINAL OEDEMA | 1/32 (3.1%) | 2/32 (6.3%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| RETINAL PIGMENT EPITHELIOPATHY | 2/32 (6.3%) | 3/32 (9.4%) | 0/31 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| VISUAL ACUITY REDUCED | 1/32 (3.1%) | 1/32 (3.1%) | 4/31 (12.9%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| VITREOUS DETACHMENT | 4/32 (12.5%) | 1/32 (3.1%) | 2/31 (6.5%) | 3/31 (9.7%) | 4/31 (12.9%) | |||||
| VITREOUS FLOATERS | 2/32 (6.3%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| EYE INFLAMMATION | 2/32 (6.3%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| EYE IRRITATION | 5/32 (15.6%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| EYE PAIN | 5/32 (15.6%) | 2/32 (6.3%) | 4/31 (12.9%) | 1/31 (3.2%) | 3/31 (9.7%) | |||||
| FOREIGN BODY SENSATION IN EYES | 3/32 (9.4%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| LACRIMATION DECREASED | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| MACULAR DEGENERATION | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| MACULOPATHY | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| PHOTOPSIA | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 2/31 (6.5%) | 3/31 (9.7%) | |||||
| PUNCTATE KERATITIS | 0/32 (0%) | 0/32 (0%) | 1/31 (3.2%) | 2/31 (6.5%) | 2/31 (6.5%) | |||||
| RETINAL DEPIGMENTATION | 2/32 (6.3%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| SUBRETINAL FIBROSIS | 2/32 (6.3%) | 1/32 (3.1%) | 1/31 (3.2%) | 2/31 (6.5%) | 2/31 (6.5%) | |||||
| VISION BLURRED | 2/32 (6.3%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| VISUAL DISTURBANCE | 2/32 (6.3%) | 1/32 (3.1%) | 0/31 (0%) | 2/31 (6.5%) | 3/31 (9.7%) | |||||
| Gastrointestinal disorders | ||||||||||
| CONSTIPATION | 5/32 (15.6%) | 1/32 (3.1%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| DIARRHOEA | 1/32 (3.1%) | 1/32 (3.1%) | 0/31 (0%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| FLATULENCE | 0/32 (0%) | 2/32 (6.3%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| NAUSEA | 3/32 (9.4%) | 0/32 (0%) | 0/31 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| General disorders | ||||||||||
| CHEST PAIN | 2/32 (6.3%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Immune system disorders | ||||||||||
| SEASONAL ALLERGY | 4/32 (12.5%) | 2/32 (6.3%) | 0/31 (0%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| Infections and infestations | ||||||||||
| BRONCHITIS | 5/32 (15.6%) | 2/32 (6.3%) | 1/31 (3.2%) | 1/31 (3.2%) | 3/31 (9.7%) | |||||
| CELLULITIS | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| CYSTITIS | 2/32 (6.3%) | 0/32 (0%) | 1/31 (3.2%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| GASTROENTERITIS VIRAL | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| HERPES ZOSTER | 0/32 (0%) | 2/32 (6.3%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| INFLUENZA | 0/32 (0%) | 2/32 (6.3%) | 2/31 (6.5%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| NASOPHARYNGITIS | 3/32 (9.4%) | 1/32 (3.1%) | 3/31 (9.7%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| PNEUMONIA | 3/32 (9.4%) | 0/32 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | 1/31 (3.2%) | |||||
| RHINOVIRUS INFECTION | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| SINUSITIS | 2/32 (6.3%) | 1/32 (3.1%) | 2/31 (6.5%) | 1/31 (3.2%) | 3/31 (9.7%) | |||||
| TOOTH ABSCESS | 1/32 (3.1%) | 1/32 (3.1%) | 1/31 (3.2%) | 2/31 (6.5%) | 0/31 (0%) | |||||
| UPPER RESPIRATORY TRACT INFECTION | 3/32 (9.4%) | 1/32 (3.1%) | 2/31 (6.5%) | 6/31 (19.4%) | 3/31 (9.7%) | |||||
| URINARY TRACT INFECTION | 1/32 (3.1%) | 3/32 (9.4%) | 6/31 (19.4%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| VULVOVAGINAL MYCOTIC INFECTION | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| FALL | 2/32 (6.3%) | 1/32 (3.1%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| JOINT SPRAIN | 0/32 (0%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| Investigations | ||||||||||
| BLOOD CREATININE INCREASED | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| BLOOD GLUCOSE INCREASED | 0/32 (0%) | 2/32 (6.3%) | 1/31 (3.2%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| BLOOD UREA INCREASED | 0/32 (0%) | 1/32 (3.1%) | 0/31 (0%) | 2/31 (6.5%) | 0/31 (0%) | |||||
| INTRAOCULAR PRESSURE INCREASED | 1/32 (3.1%) | 3/32 (9.4%) | 3/31 (9.7%) | 2/31 (6.5%) | 1/31 (3.2%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| DEHYDRATION | 1/32 (3.1%) | 1/32 (3.1%) | 2/31 (6.5%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| GOUT | 1/32 (3.1%) | 2/32 (6.3%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| HYPERCHOLESTEROLAEMIA | 4/32 (12.5%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| BACK PAIN | 1/32 (3.1%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| OSTEOARTHRITIS | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| Nervous system disorders | ||||||||||
| DEMENTIA ALZHEIMER'S TYPE | 0/32 (0%) | 2/32 (6.3%) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) | |||||
| DIZZINESS | 1/32 (3.1%) | 0/32 (0%) | 2/31 (6.5%) | 1/31 (3.2%) | 0/31 (0%) | |||||
| HEADACHE | 1/32 (3.1%) | 3/32 (9.4%) | 1/31 (3.2%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| SINUS HEADACHE | 1/32 (3.1%) | 2/32 (6.3%) | 2/31 (6.5%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| Psychiatric disorders | ||||||||||
| ANXIETY | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| DEPRESSION | 0/32 (0%) | 1/32 (3.1%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
| INSOMNIA | 2/32 (6.3%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 0/31 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| COUGH | 2/32 (6.3%) | 1/32 (3.1%) | 2/31 (6.5%) | 1/31 (3.2%) | 2/31 (6.5%) | |||||
| DYSPNOEA | 2/32 (6.3%) | 0/32 (0%) | 1/31 (3.2%) | 2/31 (6.5%) | 0/31 (0%) | |||||
| PHARYNGOLARYNGEAL PAIN | 1/32 (3.1%) | 0/32 (0%) | 0/31 (0%) | 0/31 (0%) | 2/31 (6.5%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| RASH | 2/32 (6.3%) | 0/32 (0%) | 1/31 (3.2%) | 0/31 (0%) | 1/31 (3.2%) | |||||
| Vascular disorders | ||||||||||
| HYPERTENSION | 6/32 (18.8%) | 1/32 (3.1%) | 2/31 (6.5%) | 0/31 (0%) | 3/31 (9.7%) | |||||
| HYPOTENSION | 0/32 (0%) | 0/32 (0%) | 2/31 (6.5%) | 0/31 (0%) | 0/31 (0%) | |||||
Limitations/Caveats
This is a phase 2 study with small numbers of patients per group limiting the conclusions that can be drawn from the resulting data.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Trials Administrator |
|---|---|
| Organization | Regeneron Pharmaceuticals, Inc. |
| Phone | |
| clinicaltrials@regeneron.com |
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00320788
Other Study ID Numbers:
- VGFT-OD-0508
First Posted:
May 3, 2006
Last Update Posted:
Mar 1, 2012
Last Verified:
Jan 1, 2012