NCT03699618

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

October 5, 2018

Last Update Submit

February 17, 2020

Conditions

Submacular HemorrhageWet Macular DegenerationNeovascular Age-related Macular Degeneration

Keywords

NVAMDAnti-VEGF

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (3)

  • Correlation between hemorrhage characteristics and visual acuity at month 12

    12 months

  • Correlation between hemorrhage characteristics and visual acuity at month 24

    24 months

  • Correlation between hemorrhage characteristics and good visual outcome at month 24

    24 months

Study Arms (2)

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

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

Interventions

Anti-VEGFDRUG

Standard of care treatment with anti-VEGF only

Anti-VEGF injection only
Hemorrhage displacement + Anti-VEGFOTHER

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

Hemorrhage displacement + Anti-VEGF

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (7)

  • 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.

    PMID: 29499174BACKGROUND

  • 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.

    PMID: 23851632BACKGROUND

  • 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.

    PMID: 24342019BACKGROUND

  • 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.

    PMID: 26272443BACKGROUND

  • 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.

    PMID: 23465269BACKGROUND

  • 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.

    PMID: 25307130BACKGROUND

  • 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.

    PMID: 22174095BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Peter Campochiaro, MD

    Wilmer Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

May 29, 2019

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)