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Submacular HemorrhageNCT03699618

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

An observational study of Submacular Hemorrhage and Wet Macular Degeneration, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Anti-VEGF and Hemorrhage displacement + Anti-VEGF
Type of treatment
Injection or infusion
How many people
1 participants
Where
1 siteUnited States
Study dates
29 May 2019to 6 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who develop subretinal hemorrhage (SRH) involving the fovea secondary to neovascular age-related macular degeneration will be enrolled in the study.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilmer Eye Institute, Johns Hopkins

    Baltimore, Maryland, 21287

Other trials in United States

About this study

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).

Read the 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.

Being tested
Anti-VEGF, Hemorrhage displacement + Anti-VEGF
Keywords
NVAMD, Anti-VEGF
Medical subject headings
Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-VEGFDrug

    Standard of care treatment with anti-VEGF only

  • Hemorrhage displacement + Anti-VEGFOther

    Standard of care treatment with hemorrhage displacement (at investigators' discretion) followed by anti-VEGF injections

Study groups in NCT03699618
Study groupRoleWhat they receive
Anti-VEGF injection onlyPatients 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
Receives: Drug: Anti-VEGF
Hemorrhage displacement + Anti-VEGFHemorrhage displacement (at investigators' discretion) followed by monthly intravitreal anti-VEGF injections for 12 months, and standard of care treatment interval during months 12-24
Receives: Other: Hemorrhage displacement + Anti-VEGF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between hemorrhage characteristics and good visual outcome at month 12

    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.

    Measured: 12 months

Secondary outcomes (3)

  1. Correlation between hemorrhage characteristics and visual acuity at month 12

    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

    Measured: 12 months

  2. Correlation between hemorrhage characteristics and visual acuity at month 24

    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

    Measured: 24 months

  3. Correlation between hemorrhage characteristics and good visual outcome at month 24

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start29 May 2019
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Why it stopped: Challenging Enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03699618
Sponsor's protocol ID
IRB00178395
Status last verified
Feb 2020
First submitted
5 Oct 2018
Last updated
19 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kherani S, Scott AW, Wenick AS, Zimmer-Galler I, Brady CJ, Sodhi A, Meyerle C, Solomon SD, Shaukat R, Channa R, Adeyemo O, Handa JT, Wang J, Campochiaro PA. Shortest Distance From Fovea to Subfoveal Hemorrhage Border Is Important in Patients With Neovascular Age-related Macular Degeneration. Am J Ophthalmol. 2018 May;189:86-95. doi: 10.1016/j.ajo.2018.02.015. Epub 2018 Feb 28.

    PubMed 29499174

  • Iacono P, Parodi MB, Introini U, La Spina C, Varano M, Bandello F. Intravitreal ranibizumab for choroidal neovascularization with large submacular hemorrhage in age-related macular degeneration. Retina. 2014 Feb;34(2):281-7. doi: 10.1097/IAE.0b013e3182979e33.

    PubMed 23851632

  • Kim JH, Chang YS, Kim JW, Kim CG, Yoo SJ, Cho HJ. Intravitreal anti-vascular endothelial growth factor for submacular hemorrhage from choroidal neovascularization. Ophthalmology. 2014 Apr;121(4):926-35. doi: 10.1016/j.ophtha.2013.11.004. Epub 2013 Dec 15.

    PubMed 24342019

  • Kim HS, Cho HJ, Yoo SG, Kim JH, Han JI, Lee TG, Kim JW. Intravitreal anti-vascular endothelial growth factor monotherapy for large submacular hemorrhage secondary to neovascular age-related macular degeneration. Eye (Lond). 2015 Sep;29(9):1141-51. doi: 10.1038/eye.2015.131. Epub 2015 Aug 14.

    PubMed 26272443

  • Shienbaum G, Garcia Filho CA, Flynn HW Jr, Nunes RP, Smiddy WE, Rosenfeld PJ. Management of submacular hemorrhage secondary to neovascular age-related macular degeneration with anti-vascular endothelial growth factor monotherapy. Am J Ophthalmol. 2013 Jun;155(6):1009-13. doi: 10.1016/j.ajo.2013.01.012. Epub 2013 Mar 7.

    PubMed 23465269

  • Altaweel MM, Daniel E, Martin DF, Mittra RA, Grunwald JE, Lai MM, Melamud A, Morse LS, Huang J, Ferris FL 3rd, Fine SL, Maguire MG; Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group; Comparison of Age-related Macular Degeneration Treatments Trials CATT Research Group. Outcomes of eyes with lesions composed of >50% blood in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT). Ophthalmology. 2015 Feb;122(2):391-398.e5. doi: 10.1016/j.ophtha.2014.08.020. Epub 2014 Oct 11.

    PubMed 25307130

  • Treumer F, Roider J, Hillenkamp J. Long-term outcome of subretinal coapplication of rtPA and bevacizumab followed by repeated intravitreal anti-VEGF injections for neovascular AMD with submacular haemorrhage. Br J Ophthalmol. 2012 May;96(5):708-13. doi: 10.1136/bjophthalmol-2011-300655. Epub 2011 Dec 15.

    PubMed 22174095

Questions about this trial

What is this clinical trial studying?

An observational study of Submacular Hemorrhage and Wet Macular Degeneration, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Challenging Enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between hemorrhage characteristics and good visual outcome at month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03699618, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.

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