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

Terminated

• Conditions: Neovascular Age-related Macular Degeneration; Submacular Hemorrhage; Wet Macular Degeneration
• Interventions: Drug: Anti-VEGF; Other: Hemorrhage displacement + Anti-VEGF

• Registration Number: NCT03699618
• Lead Sponsor: Johns Hopkins University

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2019-05-29
• Primary Completion: 2020-01-06
• Study Completion: 2020-01-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-VEGF injection only	Anti-VEGF	Patients who will receive monthly intravitreal anti-VEGF injection for 12 months, followed by anti-VEGF at standard of care treatment interval during months 12-24
Hemorrhage displacement + Anti-VEGF	Hemorrhage displacement + Anti-VEGF	Hemorrhage displacement (at investigators' discretion) followed by monthly intravitreal anti-VEGF injections for 12 months, and standard of care treatment interval during months 12-24

Primary Outcome Measures

Name	Time	Method
Correlation between hemorrhage characteristics and good visual outcome at month 12	12 months	Correlation between baseline SFH characteristics measured on Spectralis SD-OCT (size and thickness of SFH, and shortest distance between border of SFH and fovea) and good visual acuity outcome (≥20/50) after controlling for baseline visual acuity in patients receiving monthly IVT anti-VEGF injections using pearson or spearman correlation coefficients based on normality of the data.

Secondary Outcome Measures

Name	Time	Method
Correlation between hemorrhage characteristics and visual acuity at month 12	12 months	Correlation between baseline SFH characteristics measured on Spectralis SD-OCT (size and thickness of SFH, and shortest distance between border of SFH and fovea) and VA at 12-months using linear regression model accounting for all clinically relevant covariates including baseline VA
Correlation between hemorrhage characteristics and visual acuity at month 24	24 months	Correlation between baseline SFH characteristics measured on Spectralis SD-OCT (size and thickness of SFH, and shortest distance between border of SFH and fovea) and VA at 24-months using linear regression model accounting for all clinically relevant covariates including baseline VA
Correlation between hemorrhage characteristics and good visual outcome at month 24	24 months	Correlation between baseline SFH characteristics measured on Spectralis SD-OCT (size and thickness of SFH, and shortest distance between border of SFH and fovea) and good visual acuity outcome (≥20/50) after controlling for baseline visual acuity in patients receiving monthly IVT anti-VEGF injections using pearson or spearman correlation coefficients based on normality of the data.

Trial Locations

Locations (1)

Wilmer Eye Institute, Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States