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

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: Completed
• Conditions: Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration
• Intervention / Treatment: Drug: Eylea

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability of repeated Eylea injection	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	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	using the standardized NEI/VFQ-25 questionnaire reponses will be compared from baseline to month 12	baseline to month 12

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (ESTIMATE): May 20, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pigment Epithelial Detachment; Age-related Macular degeneration
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neoplasms; Eye Diseases; Retinal Degeneration; Retinal Diseases; Neoplastic Processes; Macular Degeneration; Neoplasm Metastasis; Retinal Detachment; Dissociative Disorders; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: Bayer-001-PED