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CompletedNCT00509795VIEW1Updated Dec 28, 2012Results posted

Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)

A Phase 3 interventional study of ranibizumab and aflibercept injection (VEGF Trap-Eye, BAY86-5321) in Macular Degeneration, sponsored by Regeneron Pharmaceuticals. Completed at 188 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-12-28.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,217
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.

02

Conditions studied

  • Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 1,217 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed Informed Consent.
  2. Men and women ≥ 50 years of age.
  3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
  4. Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters.
  5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.

Key

Exclusion criteria

Exclusion Criteria:

  1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
  2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
  3. Any prior treatment with anti-VEGF agents in the study eye.
  4. Total lesion size > 12 disc areas (30.5 mm\^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
  5. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)
  6. Scar or fibrosis, making up > 50% of total lesion in the study eye.
  7. Scar, fibrosis, or atrophy involving the center of the fovea.
  8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
  10. Presence of other causes of CNV in the study eye.
  11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
  12. Prior vitrectomy in the study eye.
  13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  14. Any history of macular hole of stage 2 and above in the study eye.
  15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,217 participants (actual)

Study arms

  • Active comparator
    ranibizumab 0.5mg Q4

    Biological: ranibizumab

  • Experimental
    aflibercept injection 2.0mg Q4

    Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

  • Experimental
    aflibercept injection 0.5mg Q4

    Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

  • Experimental
    aflibercept injection 2.0mg Q8

    Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Interventions

  • Biologicalranibizumab

    Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

    Also known as: Lucentis

  • Biologicalaflibercept injection (VEGF Trap-Eye, BAY86-5321)

    Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

    Also known as: VEGF Trap-Eye, BAY86-5321

  • Biologicalaflibercept injection (VEGF Trap-Eye, BAY86-5321)

    Participants received a 0.5mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

    Also known as: VEGF Trap-Eye, BAY86-5321

  • Biologicalaflibercept injection (VEGF Trap-Eye, BAY86-5321)

    Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

    Also known as: VEGF Trap-Eye, BAY86-5321

06

What researchers measure

Primary outcomes

  1. Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)

    Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

    Time frame: Baseline and at week 52

Secondary outcomes

  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF

    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 52

  2. Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.

    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 52

  3. Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF

    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 which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

    Time frame: Baseline and at Week 52

  4. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)

    CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.

    Time frame: Baseline and at week 52

07

Results

Posted Apr 16, 2012

Participant flow

The study was conducted at 164 sites in the United States and Canada. Recruitment period: 02 Aug 2007 to 15 Sep 2009.

Participant flow — Overall Study
MilestoneRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8
Started306304304303
Patients received treatment (saf)304304304303
Full analysis set (fas) population304304301301
Per protocol set (pps) population269285270265
Completed284293277276
Not completed22112727
Withdrew: Adverse event4354
Withdrew: Death3127
Withdrew: Lack of efficacy0022
Withdrew: Lost to follow-up1244
Withdrew: Other1041
Withdrew: Protocol violation3031
Withdrew: Withdrawal by subject10578

Outcome measures

PrimaryPercentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)

Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

Time frame:
Baseline and at week 52
Reported as:
Number · percentage of patients
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
percentage of patientsRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)94.4 ± 095.1 ± 095.9 ± 095.1 ± 095.1 ± 0
Statistical analysis
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 · Risk difference (rd): -0.7 · 95.1% CI -4.4 to 3.1The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 · Risk difference (rd): -1.5 · 95.1% CI -5.1 to 2.1The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 · Risk difference (rd): -0.7 · 95.1% CI -4.5 to 3.1The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.
SecondaryMean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF

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 52
Reported as:
Mean · letters read
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF
letters readRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF8.1 ± 15.2510.9 ± 13.776.9 ± 13.417.9 ± 15.008.5 ± 14.44
Statistical analysis
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 · ANCOVA · p = 0.0054 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: 3.15 · 95.1% CI 0.92 to 5.37The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 · ANCOVA · p = 0.4793 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: 0.80 · 95.1% CI -3.03 to 1.43The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 · ANCOVA · p = 0.8179 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: 0.26 · 95.1% CI -1.97 to 2.49The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.
SecondaryPercentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.

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 52
Reported as:
Number · percentage of patients
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.
percentage of patientsRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.30.9 ± 037.5 ± 024.9 ± 030.6 ± 031.1 ± 0
Statistical analysis
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 · Chi-squared · p = 0.1042 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.) · Risk difference (rd): 6.6 · 95.1% CI -1.0 to 14.1The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 · Chi-squared · p = 0.1037 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.) · Risk difference (rd): -6.0 · 95.1% CI -13.2 to 1.2The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 · Chi-squared · p = 0.93 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.) · Risk difference (rd): -0.4 · 95.1% CI -7.7 to 7.0The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.
SecondaryMean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF

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 which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

Time frame:
Baseline and at Week 52
Reported as:
Mean · scores on a scale
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
scores on a scaleRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF4.9 ± 14.016.7 ± 13.504.5 ± 11.875.1 ± 14.745.3 ± 13.59
Statistical analysis
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 · ANCOVA · p = 0.2090 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences least squares means: 1.28 · 95.1% CI -0.73 to 3.28The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 · ANCOVA · p = 0.5128 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: -0.67 · 95.1% CI -2.69 to 1.35The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 · ANCOVA · p = 0.5579 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: -0.60 · 95.1% CI -2.61 to 1.42The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.
SecondaryMean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)

CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.

Time frame:
Baseline and at week 52
Reported as:
Mean · mm^2
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)
mm^2Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)-4.2 ± 5.59-4.6 ± 5.47-3.5 ± 5.27-3.4 ± 6.02-3.9 ± 5.61
Statistical analysis
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 · ANCOVA · p = 0.3575 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: -0.33 · 95.1% CI -1.04 to 0.38The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 · ANCOVA · p = 0.0507 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: 0.71 · 95.1% CI -0.01 to 1.42The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4
  • Ranibizumab 0.5mg Q4 vs IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 · ANCOVA · p = 0.0173 (As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049) · Differences in least squares means: 0.86 · 95.1% CI 0.15 to 1.58The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8

Adverse events

Collected over AEs reported from Day 1 to Wk 96. Yr 1 of tx (Day 1 to Wk 52): 21-day screening period followed by administration of study drug every 4 or 8 wks including sham injections at interim study visits (when study drug was not administered) for 48 wks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ranibizumab 0.5mg Q4—94/304 (30.9%)261/304 (85.9%)
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4—70/304 (23%)254/304 (83.6%)
IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4—88/304 (28.9%)262/304 (86.2%)
IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8—90/303 (29.7%)258/303 (85.1%)
Most frequent serious events
Showing 10 of 337
Most frequent serious events
EventRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8
FALLInjury, poisoning and procedural complications8/30413/3047/30416/303
PNEUMONIAInfections and infestations14/3046/3045/3048/303
CARDIAC FAILURE CONGESTIVEEar and labyrinth disorders4/3042/3044/3048/303
ATRIAL FIBRILLATIONEar and labyrinth disorders3/3042/3047/3047/303
TRANSIENT ISCHAEMIC ATTACKNervous system disorders0/3043/3047/3045/303
CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders3/3043/3046/3046/303
CORONARY ARTERY DISEASEEar and labyrinth disorders5/3040/3046/3041/303
MYOCARDIAL INFARCTIONEar and labyrinth disorders6/3041/3045/3042/303
CEREBROVASCULAR ACCIDENTNervous system disorders2/3043/3041/3045/303
SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disordersNeoplasms benign, malignant and unspecified (incl cysts and polyps)5/3043/3042/3044/303
Most frequent other events
Showing 10 of 36
Most frequent other events
EventRanibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8
VITREOUS FLOATERSEye disorders47/30449/30430/30429/303
NASOPHARYNGITISInfections and infestations36/30446/30441/30439/303
RETINAL HAEMORRHAGEEye disorders43/30436/30436/30422/303
Eye disorders PAINEye disorders34/30439/30435/30431/303
HYPERTENSIONVascular disorders35/30430/30432/30433/303
VISUAL ACUITY REDUCEDEye disorders27/30410/30420/30419/303
UPPER RESPIRATORY TRACT Infections and infestationsIONInfections and infestations18/30418/30419/30426/303
URINARY TRACT Infections and infestationsIONInfections and infestations26/30422/30425/30423/303
VITREOUS DETACHMENTEye disorders16/30424/30425/30424/303
BRONCHITISInfections and infestations23/30419/30416/30424/303

Baseline characteristics

Age Continuous
Age Continuous(years)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean78.2 ± 7.5977.7 ± 7.9378.3 ± 8.1077.9 ± 8.3978.0 ± 8.00
Sex: Female, Male
Sex: Female, Male(Participants)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Female172194169179714
Male132110135124501
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Hispanic or Latino7 ± 011 ± 011 ± 012 ± 041
Not Hispanic or Latino2972932932911174
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
American Indian or Alaska Native2 ± 00 ± 02 ± 01 ± 05
Asian0 ± 03 ± 05 ± 04 ± 012
Native Hawaiian or Other Pacific Islander1 ± 00 ± 00 ± 01 ± 02
Black or African American1 ± 01 ± 00 ± 01 ± 03
White296 ± 0295 ± 0294 ± 0289 ± 01174
More than one race0 ± 00 ± 00 ± 01 ± 01
Unknown or Not Reported4 ± 05 ± 03 ± 06 ± 018
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score(scores on a scale)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean71.7 ± 17.2970.4 ± 16.6071.1 ± 17.7269.5 ± 16.8270.7 ± 17.11
Baseline Area of Choroidal Neovascularization (CNV)
Baseline Area of Choroidal Neovascularization (CNV)(mm^2)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean6.52 ± 5.2456.59 ± 5.0526.49 ± 4.4376.56 ± 5.1296.54 ± 4.968
Baseline Lesion Type
Baseline Lesion Type(patients)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Occult115 ± 0110 ± 0123 ± 0118 ± 0466
Minimally Classic101 ± 0105 ± 097 ± 0112 ± 0415
Predominantly Classic82 ± 087 ± 082 ± 071 ± 0322
Missing6 ± 02 ± 02 ± 02 ± 012
Baseline Total Lesion Size
Baseline Total Lesion Size(mm^2)Ranibizumab 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8Total
Mean6.99 ± 5.4916.98 ± 5.3886.96 ± 4.7116.88 ± 5.2146.95 ± 5.202

1 further baseline measures are reported on the registry.

08

Study locations

188 sites
  • Birmingham, Alabama 35205, United States
  • Birmingham, Alabama 35223, United States
  • Phoenix, Arizona 85014, United States
  • Phoenix, Arizona 85020, United States
  • Tucson, Arizona 85704, United States
  • Tucson, Arizona 85710, United States
  • Beverly Hills, California 90211, United States
  • Campbell, California 95008, United States
  • Fullerton, California 92835, United States
  • Glendale, California 91203, United States
  • Irvine, California 92697, United States
  • La Jolla, California 92037, United States
  • Loma Linda, California 92354, United States
  • Los Angeles, California 90033, United States
  • Los Angeles, California 90048, United States
  • Menlo Park, California 94025, United States
  • Mountain View, California 94040, United States
  • Oakland, California 94609, United States
  • Palm Springs, California 92262, United States
  • Pasadena, California 91105, United States
  • Poway, California 92064, United States
  • Sacramento, California 95819, United States
  • San Diego, California 92120, United States
  • San Francisco, California 94107, United States
  • Santa Ana, California 92705, United States
  • Torrance, California 90503, United States
  • Ventura, California 93003, United States
  • Westlake Village, California 91361, United States
  • Yorba Linda, California 92887, United States
  • Aurora, Colorado 80045, United States
  • Denver, Colorado 80205, United States
  • Denver, Colorado 80230, United States
  • Bridgeport, Connecticut 06606, United States
  • Hamden, Connecticut 06518, United States
  • New Haven, Connecticut 06510, United States
  • New London, Connecticut 06320, United States
  • Altamonte Springs, Florida 32701, United States
  • Boynton Beach, Florida 33426, United States
  • Fort Myers, Florida 33907, United States
  • Ft. Lauderdale, Florida 33351, United States
  • Ft. Myers, Florida 33912, United States
  • Gainesville, Florida 32610, United States
  • Jacksonville, Florida 32224, United States
  • Miami, Florida 33136, United States
  • Miami, Florida 33143, United States
  • Mount Dora, Florida 32757, United States
  • Orlando, Florida 32803, United States
  • Orlando, Florida 32806, United States
  • Oscala, Florida 34472, United States
  • Palm Beach Gardens, Florida 33410, United States
  • Pensacola, Florida 32503, United States
  • Sarasota, Florida, United States
  • Stuart, Florida 34994, United States
  • Tampa, Florida 33612, United States
  • Winter Haven, Florida 33880, United States
  • Augusta, Georgia 30909, United States
  • Aiea, Hawaii 96701, United States
  • Honolulu, Hawaii 96813, United States
  • Oak Brook, Illinois 60523, United States
  • Fort Wayne, Indiana 46804, United States
  • Indianapolis, Indiana 46202, United States
  • Indianapolis, Indiana 46260, United States
  • Indianapolis, Indiana 46280, United States
  • New Albany, Indiana 47150, United States
  • Iowa City, Iowa 52242-1091, United States
  • Wichita, Kansas 67214, United States
  • Louisville, Kentucky 40202, United States
  • Louisville, Kentucky 40207, United States
  • Paducah, Kentucky 42001, United States
  • New Orleans, Louisiana 70115, United States
  • New Orleans, Louisiana 70121, United States
  • Shreveport, Louisiana 71105, United States
  • Bangor, Maine 04401, United States
  • Portland, Maine 04102, United States
  • Baltimore, Maryland 21209, United States
  • Baltimore, Maryland 21287, United States
  • Chevy Chase, Maryland 20815, United States
  • Hagerstown, Maryland 21740, United States
  • Towson, Maryland 21204, United States
  • Boston, Massachusetts 02111, United States
  • Boston, Massachusetts 02114, United States
  • Boston, Massachusetts 02215, United States
  • Boston, Massachusetts, United States
  • Peabody, Massachusetts 01960, United States
  • Ann Arbor, Michigan 48105, United States
  • Battle Creek, Michigan 49015, United States
  • Detroit, Michigan 48202, United States
  • Grand Rapids, Michigan 49525, United States
  • Jackson, Michigan 49201, United States
  • Royal Oak, Michigan 48073, United States
  • Southfield, Michigan 48034, United States
  • West Bloomfield, Michigan 48322, United States
  • Edina, Minnesota 55435, United States
  • Minneapolis, Minnesota 55404, United States
  • Rochester, Minnesota 55905, United States
  • Florissant, Missouri 63031, United States
  • Kansas City, Missouri 64108, United States
  • Kansas City, Missouri 64111, United States
  • Springfield, Missouri 65804, United States
  • St. Louis, Missouri 63110, United States

Showing the first 100 of 188 sites across 2 countries.

09

References and documents

Publications

  • Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2. PubMed 32374423 ↗
  • Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11. PubMed 31826853 ↗
  • Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6. PubMed 25439429 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00509795
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Bayer
Responsible party
Sponsor
First posted
Aug 1, 2007
Start date
Aug 2007
Primary completion
Sep 2010
Completion
Jul 2011
Results posted
Apr 16, 2012
Last update
Dec 28, 2012

Study contacts

Robert Vitti, MD
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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