Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 3/13/2019 |
| Start Date: | April 20, 2019 |
| End Date: | December 30, 2021 |
| Contact: | Gulnar Hafiz, MD, MPH |
| Email: | ghafiz1@jhmi.edu |
| Phone: | 410-955-5106 |
This study will define the limits of subretinal hemorrhage parameters that are consistent
with a good visual outcome with aggressive anti-VEGF treatment in patients with neovascular
age-related macular degeneration (NVAMD).
with a good visual outcome with aggressive anti-VEGF treatment in patients with neovascular
age-related macular degeneration (NVAMD).
The purpose of this study is to define the limits of subretinal hemorrhage parameters that
are consistent with a good visual outcome with aggressive anti-vascular endothelial growth
factor (anti-VEGF) treatment, thereby providing guidance as to when it is reasonable to treat
with anti-VEGF and when it is necessary to displace the hemorrhage in addition to treating
with anti-VEGF.
This is a prospective study that will enroll 98 patients with subretinal hemorrhage in the
fovea [also known as subfoveal hemorrhage (SFH)] secondary to neovascular AMD at the Wilmer
Eye Institute, Johns Hopkins Hospital (Downtown campus and all other Eye Care Network
clinics). The primary endpoint is at month 12 and the secondary endpoint is at month 24. The
duration of the study is 24 months.
Study visits will include a baseline visit, then monthly visits for 12 months, followed by
standard care treatment visits in the second year until month 24. The patients will be
stratified into two groups based on standard of care management: 1. Patients receiving
intravitreal (IVT) anti-VEGF injections; 2. Patients undergoing SFH displacement followed by
IVT anti-VEGF injections. Patients will receive monthly anti-VEGF injection for 12 months,
followed by anti-VEGF at standard of care treatment interval during months 12-24; or SFH
displacement (at investigators' discretion) followed by monthly IVT anti-VEGF injections for
12 months, and standard of care treatment interval during months 12-24.
are consistent with a good visual outcome with aggressive anti-vascular endothelial growth
factor (anti-VEGF) treatment, thereby providing guidance as to when it is reasonable to treat
with anti-VEGF and when it is necessary to displace the hemorrhage in addition to treating
with anti-VEGF.
This is a prospective study that will enroll 98 patients with subretinal hemorrhage in the
fovea [also known as subfoveal hemorrhage (SFH)] secondary to neovascular AMD at the Wilmer
Eye Institute, Johns Hopkins Hospital (Downtown campus and all other Eye Care Network
clinics). The primary endpoint is at month 12 and the secondary endpoint is at month 24. The
duration of the study is 24 months.
Study visits will include a baseline visit, then monthly visits for 12 months, followed by
standard care treatment visits in the second year until month 24. The patients will be
stratified into two groups based on standard of care management: 1. Patients receiving
intravitreal (IVT) anti-VEGF injections; 2. Patients undergoing SFH displacement followed by
IVT anti-VEGF injections. Patients will receive monthly anti-VEGF injection for 12 months,
followed by anti-VEGF at standard of care treatment interval during months 12-24; or SFH
displacement (at investigators' discretion) followed by monthly IVT anti-VEGF injections for
12 months, and standard of care treatment interval during months 12-24.
Inclusion Criteria:
- Signed informed consent and authorization of use and disclosure of protected health
information
- Age 50 years or older
- Presence of subretinal hemorrhage (SRH) involving the fovea in patients with NVAMD
including polypoidal choroidal vasculopathy (PCV)
Exclusion Criteria:
- SFH in the study eye due to causes other than NVAMD
- Media opacity due to concurrent vitreous hemorrhage or cataracts that preclude
adequate imaging
- Substantial loss of VA due to condition other than AMD
- Limited visual potential from substantial atrophy or fibrosis in fovea
- Poor visual potential with known permanent reduction in visual acuity prior to SFH
We found this trial at
1
site
Click here to add this to my saved trials
