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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03699618
• Other study ID #: IRB00178395
• Status: Terminated
• Start date: May 29, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: February 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Wilmer Eye Institute, Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months
Secondary	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	24 months
Secondary	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.	24 months