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Trial record 6 of 14379 for:    Hemorrhage AND blood loss

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

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ClinicalTrials.gov Identifier: NCT03699618
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Submacular Hemorrhage Wet Macular Degeneration Neovascular Age-related Macular Degeneration Drug: Anti-VEGF Other: Hemorrhage displacement + Anti-VEGF

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.


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Study Type : Observational
Estimated Enrollment : 98 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : May 29, 2021
Estimated Study Completion Date : May 29, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
Anti-VEGF injection only
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
Drug: Anti-VEGF
Standard of care treatment with anti-VEGF only

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
Other: Hemorrhage displacement + Anti-VEGF
Standard of care treatment with hemorrhage displacement (at investigators' discretion) followed by anti-VEGF injections




Primary Outcome Measures :
  1. Correlation between hemorrhage characteristics and good visual outcome at month 12 [ Time Frame: 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 :
  1. Correlation between hemorrhage characteristics and visual acuity at month 12 [ Time Frame: 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

  2. Correlation between hemorrhage characteristics and visual acuity at month 24 [ Time Frame: 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

  3. Correlation between hemorrhage characteristics and good visual outcome at month 24 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who develop subretinal hemorrhage (SRH) involving the fovea secondary to neovascular age-related macular degeneration will be enrolled in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699618


Contacts
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Contact: Gulnar Hafiz, MD, MPH 410-955-5106 ghafiz1@jhmi.edu

Locations
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United States, Maryland
Wilmer Eye Institute, Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Gulnar Hafiz, M.D., M.P.H    410-502-0768    ghafiz@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Peter Campochiaro, MD Wilmer Eye Institute

Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03699618     History of Changes
Other Study ID Numbers: IRB00178395
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
NVAMD
Anti-VEGF

Additional relevant MeSH terms:
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Hemorrhage
Macular Degeneration
Wet Macular Degeneration
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors