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

NCT02142296 | Completed Phase 4

• 1 other identifier: Bayer-001-PED
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 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

Conditions

Retinal Pigment Epithelial Detachment Secondary to Age-related Macular Degeneration

Keywords

Pigment Epithelial Detachment; Age-related Macular degeneration

Outcome Measures

Primary Outcomes (1)

• efficacy of Eylea in patients with RPED

  visual acuity mean change from baseline compared to month 12

  baseline to month 12

Secondary Outcomes (3)

• safety and tolerability of repeated Eylea injection

  period of 1 year

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

  baseline to month 12

• effect of repeated Eyle injections on vision related quality of life

  baseline to month 12

Study Arms (1)

Eylea

OTHER

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

Interventions

Eylea DRUG

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

Also known as: Eylea is the brand name., Aflibercept is the generic name., The DIN is 02415992.

Eylea

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 31564356 DERIVED

MeSH Terms

Conditions

Retinal Detachment; Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Retinal Degeneration

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

CA (1)