Age-Related Macular Degeneration, Macular Degeneration
Conditions
Keywords
amd, age related macular degeneration, macular degeneration, neovascular
Brief summary
To evaluate the visual outcome and number of injections required during an optical coherence tomography (OCT)-guided treat and extend regimen with intravitreal aflibercept for treatment of subfoveal neovascular age-related macular degeneration (NVAMD).
Detailed description
The purpose of this study is to see how using treat and extend, a method of determining how often a patient with NVAMD should visit the retina clinic and receive treatments, affects vision in patients with this condition after treatment. The treatment the investigators are using in this study is an eye injection of a drug called aflibercept (also called EYLEA). Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular degeneration. The investigators hope that treat and extend strikes the right balance between making sure patients get all of the treatments needed, but not giving patients too many treatments (so that the side effects of treatments are minimized and so that patients don't have to make more visits than they need to maintain maximum visual gain). The experimental part of this study is determining this right balance of eye injections.
Interventions
Increased or decreased time between visits
Sponsors
Regeneron Pharmaceuticals
MidAtlantic Retina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 55 years with treatment naïve, active subfoveal NVAMD demonstrating macular fluid on optical coherence tomography (OCT) and leakage on fluorescein angiography (FA). * Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320 is eligible * Patients cannot have concurrent progressive retinal disease in the study eye. * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent
Exclusion criteria
* Prior treatment for NVAMD in the study eye, * Prior experimental treatment of NVAMD in either eye * Prior treatment with systemic anti-VEGF (vascular endothelial growth factor) agents * Prior treatment with verteporfin, plaque brachytherapy, or external-beam radiation therapy, or transpupillary thermotherapy in the study eye * Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye * History of vitreo surgical intervention in the study eye. Cataract surgery is permitted. * Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma) * Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either * require medical or surgical intervention during the 52 weeks study period to prevent or treat visual loss that might result from that condition, or * allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 52 weeks study period * Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye * Current vitreous hemorrhage in the study eye * History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Aphakia, Anterior Chamber Intraocular Lens (ACIOL), or unstable Posterior Chamber Intraocular Lens (PCIOL). * Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication) * Pregnant or breast-feeding women * Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score | Baseline to Week 52 |
Other
| Measure | Time frame |
|---|---|
| Change in Total Thickness at the Foveal Center Point on OCT | Baseline to Week 52 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Aflibercept Intravitreal aflibercept on treat and extend schedule | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intravitreal Aflibercept |
|---|---|
| Age, Continuous | 81.3 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 2 / 40 |
Outcome results
Primary
Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Time frame: Baseline to Week 52
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravitreal Aflibercept | Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score | 7.2 letters |
Other Pre-specified
Change in Total Thickness at the Foveal Center Point on OCT
Time frame: Baseline to Week 52
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravitreal Aflibercept | Change in Total Thickness at the Foveal Center Point on OCT | -143 micrometers |