Eylea to Treat Retinal Pigment Epithelial Detachment (RPED) Secondary to Wet Age-Related Macular Degeneration (wAMD)
Study Details
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:
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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
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To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
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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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- efficacy of Eylea in patients with RPED [baseline to month 12]
visual acuity mean change from baseline compared to month 12
Secondary Outcome Measures
- safety and tolerability of repeated Eylea injection [period of 1 year]
assessment of adverse events at each visit
- effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume [baseline to month 12]
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 [baseline to month 12]
using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed, informed consent.
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Men and women greater than or equal to 55 years of age.
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Recent development of RPED secondary to AMD.
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ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
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Willing and committed and able to return for all clinic visits and complete all study related procedures.
Exclusion Criteria:
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Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
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Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
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Total lesion size greater than 12 disc areas.
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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.
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Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
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Scar, fibrosis or atrophy involving the center of the fovea.
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Presence of a retinal pigment epithelial tear.
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History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
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Presence of other causes of choroidal neovascular membrane other than AMD.
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History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
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Prior vitrectomy surgery in the study eye.
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History of retinal detachment treatment in the study eye.
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History of macular hole in the study eye.
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Any intraocular/periocular surgery within 3 months of the initiation of the study.
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Prior trabeculectomy or filtering surgery in the study eye.
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Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
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Active intraocular inflammation.
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Active ocular/periocular infection.
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Any history of uveitis.
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Active scleritis or episcleritis.
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Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
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Previous radiation therapy in the region of the study eye.
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History of corneal transplant or corneal dystrophy in the study eye.
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Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
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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).
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The use of long acting steroids systemically or intraocularly.
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Any history of allergy to Proviodine or fluorescein sodium.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ivey Eye Institute | London | Ontario | Canada | N6A 4V2 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Bayer-001-PED