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
Sponsored by
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
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
No
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
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.
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
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
derived
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Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)
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