Neovascular Age-Related Macular Degeneration
Conditions
Keywords
Neovascular age-related macular degeneration (NVAMD)
Brief summary
The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)
Interventions
Zimura 2 mg, administered by intravitreal injection
DRUGAvastin
Avastin 1.25 mg, administered by intravitreal injection
DRUGLucentis
Lucentis 0.5 mg, administered by intravitreal injection
DRUGEylea
Eylea 2 mg, administered by intravitreal injection
Sponsors
IVERIC bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be \< 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment. * Presence of subfoveal active choroidal neovascularization (CNV)
Exclusion criteria
* Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections. * Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. * Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry. * Prior thermal laser in the macular region, regardless of indication. * Ocular or periocular infection in the past twelve weeks. * History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant. * Previous therapeutic radiation in the region of the study eye. * Evidence of diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >0 Letter Loss | Month 12 | Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed. |
| Percentage of Participants With >5 Letter Loss | Month 12 | Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed. |
| Percentage of Participants With >10 Letter Loss | Month 12 | Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zimura and Avastin Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection | 1 |
| Zimura and Lucentis Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection | 0 |
| Zimura and Eylea Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Zimura and Lucentis | Zimura and Eylea | Total | Zimura and Avastin |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | — | — | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Time frame: Month 12
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >0 Letter Loss | 0 percentage of participants |
Primary
Percentage of Participants With >0 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Time frame: Month 18
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >0 Letter Loss | 0 percentage of participants |
Primary
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Time frame: Month 12
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >10 Letter Loss | 0 percentage of participants |
Primary
Percentage of Participants With >10 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Time frame: Month 18
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >10 Letter Loss | 0 percentage of participants |
Primary
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Time frame: Month 12
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >5 Letter Loss | 0 percentage of participants |
Primary
Percentage of Participants With >5 Letter Loss
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Time frame: Month 18
Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zimura and Avastin | Percentage of Participants With >5 Letter Loss | 0 percentage of participants |