Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)

February 15, 2017 updated by: John Gonder, Lawson Health Research Institute

A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration

Primary Objectives:

To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.

Secondary Objectives:

  1. To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year
  2. To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
  3. To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire

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.

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.
37

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Ivey Eye Institute

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed, informed consent.
  2. Men and women greater than or equal to 55 years of age.
  3. Recent development of RPED secondary to AMD.
  4. ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
  5. Willing and committed and able to return for all clinic visits and complete all study related procedures.

Exclusion Criteria:

  1. Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
  2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
  3. Total lesion size greater than 12 disc areas.
  4. Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
  5. Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
  6. Scar, fibrosis or atrophy involving the center of the fovea.
  7. Presence of a retinal pigment epithelial tear.
  8. History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
  9. Presence of other causes of choroidal neovascular membrane other than AMD.
  10. History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
  11. Prior vitrectomy surgery in the study eye.
  12. History of retinal detachment treatment in the study eye.
  13. History of macular hole in the study eye.
  14. Any intraocular/periocular surgery within 3 months of the initiation of the study.
  15. Prior trabeculectomy or filtering surgery in the study eye.
  16. Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
  17. Active intraocular inflammation.
  18. Active ocular/periocular infection.
  19. Any history of uveitis.
  20. Active scleritis or episcleritis.
  21. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
  22. Previous radiation therapy in the region of the study eye.
  23. History of corneal transplant or corneal dystrophy in the study eye.
  24. Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
  25. Any disease or ocular condition which, in the opinion of the investigator could either increase in the risk to the subject beyond what is expected from a standard procedure of intraocular injections or which may be considered contraindicated for the use of the investigational drug (VEGF Trap).
  26. The use of long acting steroids systemically or intraocularly.
  27. Any history of allergy to Proviodine or fluorescein sodium.

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.
OTHER: Eylea
The intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study.
Drug: Eylea
monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
Other Names:
  • Eylea is the brand name.
  • Aflibercept is the generic name.
  • The DIN is 02415992.

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
efficacy of Eylea in patients with RPED
Time Frame: baseline to month 12
visual acuity mean change from baseline compared to month 12
baseline to month 12

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
safety and tolerability of repeated Eylea injection
Time Frame: period of 1 year
assessment of adverse events at each visit
period of 1 year
effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume
Time Frame: baseline to month 12
using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12
baseline to month 12
effect of repeated Eyle injections on vision related quality of life
Time Frame: baseline to month 12
using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
baseline to month 12

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.
Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
May 1, 2014

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.
November 1, 2016

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.
November 1, 2016

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).
May 16, 2014

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 19, 2014

First Posted (ESTIMATE)

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 20, 2014

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 16, 2017

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 15, 2017

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, 2017

More Information

Terms related to this study

Keywords

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.
  • Bayer-001-PED

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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