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Intravitreal Aflibercept for Submacular Hemorrhage

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ClinicalTrials.gov Identifier: NCT03169660
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Jae Hui Kim, Kim's Eye Hospital

Brief Summary:
The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular hemorrhage is generally poor. A recently developed anti-VEGF agent eyeliaTM is also a useful treatment option for exudative AMD. However, one major limitation of VIEW study was that lack of data regarding eyes with submacular hemorrhage. The purpose of the present study was to evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: Vascular endothelial growth factor trap-eye Phase 4

Detailed Description:

The prognosis of exudative age-related macular degeneration (AMD) accompanied by submacular hemorrhage is generally poor. Although anti-vascular endothelial growth factor (VEGF) has been demonstrated excellent efficacy in the treatment of exudative AMD, eyes with submacular hemorrhage were excluded from the previous well-known clinical trials. The exclusion of these patients may probably be determined by some concerns suggesting possible poor prognosis in these patients. Firstly, it was well known that subretinal hemorrhage itself induces retinal damage and degeneration. Secondly, it was not certain whether the drug penetrates through hemorrhage and stabilize to the underlying lesion or not. As a result, the efficacy in submacular hemorrhage could not be demonstrated in these clinical trials.

The efficacy of anti-VEGF therapy in eyes with submacular hemorrhage has recently been spotlighted. Several reports demonstrated significant improvement in visual acuity after anti-VEGF monotherapy, including LucentisTM, AvastinTM, or both, in eyes with exudative AMD with submacular hemorrhage. Although histopathologic evidence using animal model has not been presented, results of these clinical studies suggest that anti-VEGF may penetrates the hemorrhage and stabilize the underlying lesion. Recently, a large prospective clinical trial that evaluated the efficacy of anti-VEGF therapy in this condition showed favorable outcome. Result of this study may be published in a near future

A recently developed anti-VEGF agent eyeliaTM is also a useful treatment option for exudative AMD. The result of VIEW study clearly demonstrated that this new agent has comparable efficacy to LucentisTM using less frequent injection schedule. However, one major limitation of VIEW study was that lack of data regarding eyes with submacular hemorrhage. Investigators carefully reviewed the study protocol of VIEW study and found that lesions composed of >50% blood were excluded. In addition, investigators could not aware any report in English literature that evaluated the efficacy of eyeliaTM in exudative AMD with submacular hemorrhage.

It took almost 8 years to demonstrate the efficacy of two previously available anti-VEGF agents (LucentisTM and AvastinTM) in eyes with submacular hemorrhage. Investigators believe that a prospective study evaluating the efficacy of eyeliaTM in exudative AMD with submacular hemorrhage may help to achieve a consensus that eyeliaTM is also a useful treatment for submacular hemorrhage within a relatively short time.

The purpose of the present study was to evaluate the efficacy of Eylea in submacular hemorrhage secondary to exudative AMD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intravitreal Aflibercept Monotherapy for Submacular Hemorrhage Secondary to Neovascular Age-Related Macular Degeneration: A Prospective Clinical Trial
Actual Study Start Date : December 2015
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Eyes with submacular hemorrhage secondary to exudative age-related macular degeneration and were treated with vascular endothelial growth factor trap-eye.
Drug: Vascular endothelial growth factor trap-eye
Intravitreal injection of vascular endothelial growth factor trap-eye During the first 3 months, 3 monthly injections are performed After 3 serial injections, additional injections are performed once per 2 months until 48 weeks after the initial injection.
Other Name: Eylea




Primary Outcome Measures :
  1. Changes in Early Treatment of Diabetic Retinopathy Study visual acuity Score [ Time Frame: Changes from baseline in visual acuity at 56 weeks ]
    Increase or decrease in the Early Treatment of Diabetic Retinopathy Study letter score


Secondary Outcome Measures :
  1. Proportion of patients who exhibited 15 letters or greater change in visual acuity [ Time Frame: 56 weeks ]
    Changes in visual acuity of 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or greater

  2. Changes in central macular thickness [ Time Frame: Changes from baseline in central macular thickness at 56 weeks ]
    Changes in central macular thickness (1 mm diameter centered at the centered at the fovea which is measured by optical coherence tomography)

  3. Duration of complete hemorrahge resolution [ Time Frame: 56 weeks ]
    Duration between the first injection and the complete hemorrhage resolution

  4. Incidence of recurrence of submacular hemorrhage or fluid [ Time Frame: 56 weeks ]
    New development or increase in the amount of hemorrhage or fluid

  5. Leakage on angiography [ Time Frame: 56 week ]
    Leakage on angiography



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years of older
  2. Newly diagnosed, treatment-naïve exudative AMD
  3. Fovea-involving submacular hemorrhage greater than 1 disc areas at diagnosis

Exclusion Criteria:

  1. History of previous treatment for neovascular AMD
  2. Greater than 15 disc diameter areas of hemorrhage extent
  3. History of vitreoretinal surgery
  4. History of glaucoma surgery, such as trabeculectomy or glaucoma implant surgery
  5. History of ocular steroid injection therapy within 1 month
  6. History of cataract surgery within 3 months
  7. Aphakia or anterior chamber intraocular lens implantation
  8. Spherical equivalents greater than -6.0 diopters
  9. evidence of other retinal disorders that may affect visual function including diabetic retinopathy, hypertensive retinopathy, epiretinal membrane, macular hole, and microaneurysm
  10. severe media opacity
  11. uncontrolled systemic disorders, including hypertension or diabetes mellitus
  12. history of major systemic vascular events, such as myocardial infarction and stroke
  13. hypersensitivity to aflibercept
  14. ocular or periocular infection
  15. active intraocular inflammation

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): NCT03169660


Locations
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Korea, Republic of
Kim's Eye Hospital
Seoul, Korea, Republic of, 150-034
Sponsors and Collaborators
Kim's Eye Hospital
Bayer
Investigators
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Principal Investigator: Jong Woo Kim, M.D. Kim's Eye Hospital, Seoul, South Korea

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Responsible Party: Jae Hui Kim, M.D., Kim's Eye Hospital
ClinicalTrials.gov Identifier: NCT03169660    
Other Study ID Numbers: A-2014-032
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Macular Degeneration
Hemorrhage
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs