NCT03699618

Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Submacular Hemorrhage
• Wet Macular Degeneration
• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Anti-VEGF	Standard of care treatment with anti-VEGF only
OTHER	Hemorrhage displacement + Anti-VEGF	Standard of care treatment with hemorrhage displacement (at investigators' discretion) followed by anti-VEGF injections

Timeline

• Start date: 2019-05-29
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2018-10-09
• Last updated: 2020-02-19

Locations

1 site across 1 country: United States