Intravitreal Aflibercept for Submacular Hemorrhage

February 19, 2019 updated by: Jae Hui Kim, Kim's Eye Hospital

Efficacy of Intravitreal Aflibercept Monotherapy for Submacular Hemorrhage Secondary to Neovascular Age-Related Macular Degeneration: A Prospective Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Changes from baseline in visual acuity at 56 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
56 weeks
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)
Changes from baseline in central macular thickness at 56 weeks
Duration of complete hemorrahge resolution
Time Frame: 56 weeks
Duration between the first injection and the complete hemorrhage resolution
56 weeks
Incidence of recurrence of submacular hemorrhage or fluid
Time Frame: 56 weeks
New development or increase in the amount of hemorrhage or fluid
56 weeks
Leakage on angiography
Time Frame: 56 week
Leakage on angiography
56 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kim's Eye Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jong Woo Kim, M.D., Kim's Eye Hospital, Seoul, South Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-2014-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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