Macular Degeneration
Conditions
Keywords
VEGF Trap-Eye, Macular Degeneration, AMD, Neovascular Age-Related Macular Degeneration
Brief summary
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
Detailed description
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).
Interventions
DRUGVEGF Trap Eye
Intravitreal injection
Sponsors
Bayer
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior participation in VEGF Trap-Eye Phase I and II studies
Exclusion criteria
* Any ocular or systemic adverse events that would preclude participation * Presence of any condition that would jeopardize subject's participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) | Baseline of this study to Wk 152 | Number of participants with AEs summarized by category |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency (Number of Injections) | Baseline of this study to Wk 152 | Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment). |
| Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values | Baseline of original study to Wk 156 | 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 35 sites in the United States that participated in the Phase 1 and Phase 2 studies VGFT OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). The recruitment period occurred between 19 Oct 2007 and 29 Oct 2008.
Pre-assignment details
One hundred fifty seven participants were eligible if they had neovascular Age-related Macular Degeneration (AMD) and completed dosing in the Phase 1 and Phase 2 studies VGFT-OD-0502 (NCT00320775), -0508 (NCT00320788), or -0603 (NCT00383370). For each subject, only one eye was designated as the study eye.
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks. | 157 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | OTHER | 4 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg |
|---|---|
| Age Continuous | 77.9 years STANDARD_DEVIATION 8.16 |
| Baseline Best Corrected Visual Acuity (BCVA) | 61.3 scores on a scale STANDARD_DEVIATION 15.35 |
| Baseline Intraocular Pressure | 14.5 mmHg STANDARD_DEVIATION 3.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 156 Participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 149 / 157 |
| serious Total, serious adverse events | 72 / 157 |
Outcome results
Primary
Number of Participants With Adverse Events (AE)
Number of participants with AEs summarized by category
Time frame: Baseline of this study to Wk 152
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Number of participants with any AE | 154 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any ocular AE (Study eye and Fellow eye) | 138 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any non ocular AE | 151 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any treatment related AE (Ocular and non ocular) | 5 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any SAE | 72 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any AEs leading to withdrawal from study | 5 participants |
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Number of Participants With Adverse Events (AE) | Any Death due to AE | 11 participants |
Secondary
Frequency (Number of Injections)
Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).
Time frame: Baseline of this study to Wk 152
Population: A total of 1116 PRN injections were administered into the study eyes of 135 participants between baseline of this study to Week 152 (end of treatment). Of the 157 enrolled participants, 22 received no injections, and 15 received 1 injection.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Frequency (Number of Injections) | 6.0 Injections |
Secondary
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
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 of original study to Wk 156
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg | Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values | 4.1 letters read | Standard Deviation 17.71 |