VIBRANT: Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)
Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01521559
Collaborator
Bayer (Industry)
183
56
2
23
3.3
0.1
Study Details
Study Description
Brief Summary
This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Masked, Randomized, Active-Controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI]) in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Mar 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Macular Laser Photocoagulation Treatment (Control) Participants will receive macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants will receive treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. |
Procedure: Macular Laser Photocoagulation
|
| Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 Participants will receive 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group may receive laser rescue at week 36. |
Drug: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)
|
Outcome Measures
Primary Outcome Measures
- Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF [Baseline to week 24]
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.
Secondary Outcome Measures
- Change From Baseline to Week 24 in BCVA Score - LOCF [Baseline to Week 24]
Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.
- Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [Baseline to week 24]
CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).
- Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF [Baseline to week 24]
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
The following inclusion criteria include, but are not limited to:
-
Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
-
ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
-
Provide signed informed consent
Exclusion Criteria:
The following exclusion criteria include, but are not limited to:
-
Current bilateral manifestation of BRVO
-
Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
-
Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
-
Uncontrolled diabetes mellitus (DM)
-
Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
-
Use of periocular corticosteroids in the study eye within 3 months before day 1
-
Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
-
Previous administration of systemic anti-angiogenic medications
-
Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix | Arizona | United States | ||
| 2 | Tucson | Arizona | United States | ||
| 3 | Beverly Hills | California | United States | ||
| 4 | La Jolla | California | United States | ||
| 5 | Mountain View | California | United States | ||
| 6 | Palm Desert | California | United States | ||
| 7 | Sacramento | California | United States | ||
| 8 | Colorado Springs | Colorado | United States | ||
| 9 | Fort Myers | Florida | United States | ||
| 10 | Miami | Florida | United States | ||
| 11 | Plantation | Florida | United States | ||
| 12 | Stuart | Florida | United States | ||
| 13 | Tampa | Florida | United States | ||
| 14 | Winter Haven | Florida | United States | ||
| 15 | Augusta | Georgia | United States | ||
| 16 | Chicago | Illinois | United States | ||
| 17 | Baltimore (2 locations) | Maryland | United States | ||
| 18 | Hagerstown | Maryland | United States | ||
| 19 | Boston (2 locations) | Massachusetts | United States | ||
| 20 | Grand Rapids | Michigan | United States | ||
| 21 | Jackson | Michigan | United States | ||
| 22 | Southfield | Michigan | United States | ||
| 23 | Florissant | Missouri | United States | ||
| 24 | Lincoln | Nebraska | United States | ||
| 25 | Las Vegas | Nevada | United States | ||
| 26 | Teaneck | New Jersey | United States | ||
| 27 | Orchard Park | New York | United States | ||
| 28 | Syracuse | New York | United States | ||
| 29 | Charlotte | North Carolina | United States | ||
| 30 | Oklahoma City | Oklahoma | United States | ||
| 31 | Portland | Oregon | United States | ||
| 32 | Kingston | Pennsylvania | United States | ||
| 33 | West Mifflin | Pennsylvania | United States | ||
| 34 | Florence | South Carolina | United States | ||
| 35 | Ladson | South Carolina | United States | ||
| 36 | West Columbia | South Carolina | United States | ||
| 37 | Rapid City | South Dakota | United States | ||
| 38 | Nashville | Tennessee | United States | ||
| 39 | Abilene | Texas | United States | ||
| 40 | Ft. Worth | Texas | United States | ||
| 41 | Harlingen | Texas | United States | ||
| 42 | Houston | Texas | United States | ||
| 43 | San Antonio | Texas | United States | ||
| 44 | Seattle | Washington | United States | ||
| 45 | Milwaukee | Wisconsin | United States | ||
| 46 | Vancouver | British Columbia | Canada | ||
| 47 | Victoria | British Columbia | Canada | ||
| 48 | Mississauga | Ontario | Canada | ||
| 49 | Toronto | Ontario | Canada | ||
| 50 | Urayasu-shi | Chiba | Japan | ||
| 51 | Amagasaki | Hyogo | Japan | ||
| 52 | Kagoshima-shi | Kagoshima | Japan | ||
| 53 | Hamamatsu-shi | Shizuoka | Japan | ||
| 54 | Fukushima | Japan | |||
| 55 | Kyoto | Japan | |||
| 56 | Osaka | Japan |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Bayer
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01521559
Other Study ID Numbers:
- VGFTe-RVO-1027
First Posted:
Jan 30, 2012
Last Update Posted:
Nov 13, 2014
Last Verified:
Nov 1, 2014
Study Results
Participant Flow
| Recruitment Details | Participants with macular edema secondary to branch retinal vein occlusion (BRVO) involving the center of the macula in the study eye were eligible to participate in the study. |
|---|---|
| Pre-assignment Detail | Of 281 participants who were screened for inclusion in the study, 183 were enrolled (started) and 183 received treatment. |
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. | Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36. |
| Period Title: Overall Study | ||
| STARTED | 92 | 91 |
| Completed Week 24 | 83 | 85 |
| Completed Week 52 | 77 | 73 |
| COMPLETED | 77 | 73 |
| NOT COMPLETED | 15 | 18 |
Baseline Characteristics
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | Total |
|---|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36. | Total of all reporting groups |
| Overall Participants | 90 | 91 | 181 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.9
(11.37)
|
67.0
(10.41)
|
65.5
(10.98)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
36
40%
|
47
51.6%
|
83
45.9%
|
| Male |
54
60%
|
44
48.4%
|
98
54.1%
|
Outcome Measures
| Title | Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF |
|---|---|
| Description | Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data. |
| Time Frame | Baseline to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24. |
| Measure Participants | 90 | 91 |
| Number [participants] |
24
26.7%
|
48
52.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Macular Laser Photocoagulation Treatment (Control), Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200). | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 26.6 | |
| Confidence Interval |
(2-Sided) 95% 13.0 to 40.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA >20/200). | |
| Title | Change From Baseline to Week 24 in BCVA Score - LOCF |
|---|---|
| Description | Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data. |
| Time Frame | Baseline to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24. |
| Measure Participants | 90 | 91 |
| Mean (Standard Deviation) [letters correctly read] |
6.9
(12.91)
|
17.0
(11.88)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Macular Laser Photocoagulation Treatment (Control), Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Comments | Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 10.5 | |
| Confidence Interval |
(2-Sided) 95% 7.1 to 14.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |
|---|---|
| Description | CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT). |
| Time Frame | Baseline to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 |
| Measure Participants | 90 | 91 |
| Mean (Standard Deviation) [microns] |
-128.0
(195.02)
|
-280.5
(189.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Macular Laser Photocoagulation Treatment (Control), Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Comments | Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -148.6 | |
| Confidence Interval |
(2-Sided) 95% -179.8 to -117.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF |
|---|---|
| Description | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. |
| Time Frame | Baseline to week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24. |
| Measure Participants | 87 | 88 |
| Mean (Standard Deviation) [scores on a scale] |
6.3
(12.34)
|
7.7
(11.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Macular Laser Photocoagulation Treatment (Control), Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) |
|---|---|---|
| Comments | Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0833 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% -0.3 to 5.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Through Week 52 (end of study) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set (SAF) included all enrolled participants who received any investigational product; it is based on the treatment received (as treated). | |||
| Arm/Group Title | Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | ||
| Arm/Group Description | Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing. | Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36. | ||
All Cause Mortality |
||||
| Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/92 (10.9%) | 13/91 (14.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/92 (0%) | 2/91 (2.2%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/92 (0%) | 1/91 (1.1%) | ||
| Atrial flutter | 1/92 (1.1%) | 0/91 (0%) | ||
| Atrioventricular block second degree | 0/92 (0%) | 1/91 (1.1%) | ||
| Bradycardia | 0/92 (0%) | 1/91 (1.1%) | ||
| Cardiac failure acute | 1/92 (1.1%) | 0/91 (0%) | ||
| Cardiomyopathy | 0/92 (0%) | 1/91 (1.1%) | ||
| Coronary artery disease | 0/92 (0%) | 1/91 (1.1%) | ||
| Myocardial infarction | 1/92 (1.1%) | 0/91 (0%) | ||
| Gastrointestinal disorders | ||||
| Gastritis | 0/92 (0%) | 1/91 (1.1%) | ||
| Intestinal fistula | 0/92 (0%) | 1/91 (1.1%) | ||
| Large intestine polyp | 0/92 (0%) | 1/91 (1.1%) | ||
| Small intestinal obstruction | 0/92 (0%) | 1/91 (1.1%) | ||
| General disorders | ||||
| Chest pain | 0/92 (0%) | 1/91 (1.1%) | ||
| Hernia | 1/92 (1.1%) | 0/91 (0%) | ||
| Non-cardiac chest pain | 1/92 (1.1%) | 0/91 (0%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 0/92 (0%) | 1/91 (1.1%) | ||
| Osteomyelitis | 1/92 (1.1%) | 0/91 (0%) | ||
| Pelvic abscess | 0/92 (0%) | 1/91 (1.1%) | ||
| Pneumonia | 1/92 (1.1%) | 2/91 (2.2%) | ||
| Pyelonephritis | 0/92 (0%) | 1/91 (1.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Cataract traumatic | 0/92 (0%) | 1/91 (1.1%) | ||
| Delayed haemolytic transfusion reaction | 0/92 (0%) | 1/91 (1.1%) | ||
| Road traffic accident | 1/92 (1.1%) | 0/91 (0%) | ||
| Investigations | ||||
| Transaminases increased | 0/92 (0%) | 1/91 (1.1%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/92 (2.2%) | 0/91 (0%) | ||
| Hypomagnesaemia | 1/92 (1.1%) | 0/91 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Cervical spinal stenosis | 1/92 (1.1%) | 0/91 (0%) | ||
| Osteonecrosis | 1/92 (1.1%) | 0/91 (0%) | ||
| Spinal column stenosis | 1/92 (1.1%) | 0/91 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer metastatic | 0/92 (0%) | 1/91 (1.1%) | ||
| Lung adenocarcinoma | 0/92 (0%) | 1/91 (1.1%) | ||
| Squamous cell carcinoma | 0/92 (0%) | 1/91 (1.1%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/92 (1.1%) | 0/91 (0%) | ||
| Hypoaesthesia | 0/92 (0%) | 1/91 (1.1%) | ||
| Presyncope | 0/92 (0%) | 1/91 (1.1%) | ||
| Subarachnoid haemorrhage | 1/92 (1.1%) | 0/91 (0%) | ||
| Syncope | 1/92 (1.1%) | 0/91 (0%) | ||
| Renal and urinary disorders | ||||
| Hydronephrosis | 0/92 (0%) | 1/91 (1.1%) | ||
| Nephrolithiasis | 0/92 (0%) | 1/91 (1.1%) | ||
| Renal failure | 1/92 (1.1%) | 0/91 (0%) | ||
| Renal failure acute | 1/92 (1.1%) | 1/91 (1.1%) | ||
| Vascular disorders | ||||
| Aortic stenosis | 1/92 (1.1%) | 0/91 (0%) | ||
| Hypertension | 1/92 (1.1%) | 1/91 (1.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Macular Laser Photocoagulation Treatment (Control) | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/92 (32.6%) | 25/91 (27.5%) | ||
| Eye disorders | ||||
| Conjunctival haemorrhage | 14/92 (15.2%) | 22/91 (24.2%) | ||
| Eye irritation | 1/92 (1.1%) | 7/91 (7.7%) | ||
| Eye pain | 7/92 (7.6%) | 5/91 (5.5%) | ||
| Infections and infestations | ||||
| Bronchitis | 2/92 (2.2%) | 6/91 (6.6%) | ||
| Nasopharyngitis | 8/92 (8.7%) | 8/91 (8.8%) | ||
| Urinary tract infection | 7/92 (7.6%) | 3/91 (3.3%) | ||
| Investigations | ||||
| Blood pressure increased | 5/92 (5.4%) | 4/91 (4.4%) | ||
| Vascular disorders | ||||
| Hypertension | 15/92 (16.3%) | 9/91 (9.9%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Without the prior written agreement of the Sponsor, the Institution (I) shall not publish, submit or present for publication, directly or indirectly, any Manuscript (M) prior to publication of an article in a peer-reviewed scientific journal summarizing data generated by all Study centers, unless no such article is so published before the first anniversary of the finalization of the clinical study report, in which case the (I) may publish or submit for publication a (M) without further delay.
Results Point of Contact
| Name/Title | Clinical Trials Administrator |
|---|---|
| Organization | Regeneron |
| Phone | 914 847 5385 |
| clinicaltrials@regeneron.com |
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01521559
Other Study ID Numbers:
- VGFTe-RVO-1027
First Posted:
Jan 30, 2012
Last Update Posted:
Nov 13, 2014
Last Verified:
Nov 1, 2014