Age-related Macular Degeneration
Conditions
Keywords
Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®
Brief summary
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
Detailed description
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a Simultaneous Regimen (Fovista® administered with anti-VEGF same day) or Pre-Treatment Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).
Interventions
DRUGFovista® (anti-PDGF BB) plus anti-VEGF
Sponsors
Ophthotech Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects of either gender aged ≥ 50 years * All fluorescein angiographic subtypes with presence of active choroidal neovascularization
Exclusion criteria
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication * Subjects with subfoveal scar or subfoveal atrophy * Any ocular or periocular infection in the past twelve (12) weeks * History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | 2 years | Number of subjects on either arm with non-serious adverse events (reported by \>5% of subjects) |
| Number of Subjects With Serious Adverse Events | 2 years | Number of subjects with serious adverse events in each arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Simultaneous regimen followed by quarterly administration | 63 |
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a Pre-Treatment regimen followed by quarterly administration | 38 |
| Total | 101 |
Baseline characteristics
| Characteristic | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen | Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 60 Participants | 92 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Continuous | 74.8 years STANDARD_DEVIATION 9.89 | 78.3 years STANDARD_DEVIATION 7.92 | 77.0 years STANDARD_DEVIATION 8.82 |
| Region of Enrollment United States | 38 participants | 63 participants | 101 participants |
| Sex: Female, Male Female | 29 Participants | 40 Participants | 69 Participants |
| Sex: Female, Male Male | 9 Participants | 23 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 63 | 2 / 38 |
| other Total, other adverse events | 51 / 63 | 34 / 38 |
| serious Total, serious adverse events | 19 / 63 | 8 / 38 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events
Number of subjects with serious adverse events in each arm
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen | Number of Subjects With Serious Adverse Events | 19 Participants |
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen | Number of Subjects With Serious Adverse Events | 8 Participants |
Primary
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
Number of subjects on either arm with non-serious adverse events (reported by \>5% of subjects)
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen | Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | 51 Participants |
| Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen | Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) | 34 Participants |