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

Primary Purpose

Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Eylea

About this trial

This is an interventional treatment trial for Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration focused on measuring Pigment Epithelial Detachment, Age-related Macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
Total lesion size greater than 12 disc areas.
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.
Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
Scar, fibrosis or atrophy involving the center of the fovea.
Presence of a retinal pigment epithelial tear.
History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
Presence of other causes of choroidal neovascular membrane other than AMD.
History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
Prior vitrectomy surgery in the study eye.
History of retinal detachment treatment in the study eye.
History of macular hole in the study eye.
Any intraocular/periocular surgery within 3 months of the initiation of the study.
Prior trabeculectomy or filtering surgery in the study eye.
Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
Active intraocular inflammation.
Active ocular/periocular infection.
Any history of uveitis.
Active scleritis or episcleritis.
Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
Previous radiation therapy in the region of the study eye.
History of corneal transplant or corneal dystrophy in the study eye.
Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
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).
The use of long acting steroids systemically or intraocularly.
Any history of allergy to Proviodine or fluorescein sodium.

Sites / Locations

Ivey Eye Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Eylea

Arm Description

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.

Outcomes

Primary Outcome Measures

efficacy of Eylea in patients with RPED

visual acuity mean change from baseline compared to month 12

Secondary Outcome Measures

safety and tolerability of repeated Eylea injection

assessment of adverse events at each visit

effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume

using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12

effect of repeated Eyle injections on vision related quality of life

using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12

Full Information

NCT ID

NCT02142296

First Posted

May 16, 2014

Last Updated

February 15, 2017

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02142296

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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: 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 To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration

Keywords

Pigment Epithelial Detachment, Age-related Macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eylea

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Eylea

Other Intervention Name(s)

Eylea is the brand name., Aflibercept is the generic name., The DIN is 02415992.

Intervention Description

monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml

Primary Outcome Measure Information:

Title

efficacy of Eylea in patients with RPED

Description

visual acuity mean change from baseline compared to month 12

Time Frame

baseline to month 12

Secondary Outcome Measure Information:

Title

safety and tolerability of repeated Eylea injection

Description

assessment of adverse events at each visit

Time Frame

period of 1 year

Title

effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume

Description

using OCT (optical coherence tomography) thickness, volume and height will be compared from baseline to month 12

Time Frame

baseline to month 12

Title

effect of repeated Eyle injections on vision related quality of life

Description

using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12

Time Frame

baseline to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed, informed consent. Men and women greater than or equal to 55 years of age. Recent development of RPED secondary to AMD. ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye. Willing and committed and able to return for all clinic visits and complete all study related procedures. Exclusion Criteria: Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only) Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye. Total lesion size greater than 12 disc areas. 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. Scar or fibrosis making up greater than 50% of the total lesion in the study eye. Scar, fibrosis or atrophy involving the center of the fovea. Presence of a retinal pigment epithelial tear. History of a vitreous hemorrhage within 4 weeks prior to initiation of the study. Presence of other causes of choroidal neovascular membrane other than AMD. History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes Prior vitrectomy surgery in the study eye. History of retinal detachment treatment in the study eye. History of macular hole in the study eye. Any intraocular/periocular surgery within 3 months of the initiation of the study. Prior trabeculectomy or filtering surgery in the study eye. Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment. Active intraocular inflammation. Active ocular/periocular infection. Any history of uveitis. Active scleritis or episcleritis. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye. Previous radiation therapy in the region of the study eye. History of corneal transplant or corneal dystrophy in the study eye. Significant medial opacities including cataract that may interfere with visual acuity or fundus photography. 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). The use of long acting steroids systemically or intraocularly. Any history of allergy to Proviodine or fluorescein sodium.

Facility Information:

Facility Name

Ivey Eye Institute

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

31564356

Citation

Diaconita V, Li B, Pal L, Bahnacy F, Gonder JR. Prospective evaluation of aflibercept in pigment epithelial detachments secondary to neovascular age related macular degeneration. Can J Ophthalmol. 2019 Oct;54(5):626-634. doi: 10.1016/j.jcjo.2019.01.004. Epub 2019 Apr 3.

Results Reference

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

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