Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept

NCT03468296 | Unknown Phase 4 FDA Drug

• 1 other identifier: VGFTe-AMD-1819
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety and efficacy of every 2 week intravitreal aflibercept injections in a population of neovascular AMD patients that have demonstrated refractory subretinal fluid with or without intraretinal fluid despite prior monthly intravitreal aflibercept treatment.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Frequency and severity of ocular and systemic adverse events

  Through Week 14

Secondary Outcomes (9)

• Retinal Thickness

  Weeks 14, 16, 24, 52

• Subretinal Fluid Height

  Weeks 14, 16, 24, 52

• Pigment Epithelial Detachment Height

  Weeks 14, 16, 24, 52

• Proportion of Dry Maculas

  Weeks 14, 16, 24, 52

• Best-Corrected Visual Acuity

  Weeks 14, 24, and 52

Study Arms (2)

Continued Q2 Week Treatment

EXPERIMENTAL

Will receive intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24

Drug: Intravitreal Aflibercept Injection 2mg

Treat-And-Extend Treatment

ACTIVE COMPARATOR

Will receive intravitreal aflibercept (2.0mg) injections on a treat-and-extend basis through week 24 with a minimum inter-treatment interval of q4 weeks.

Drug: Intravitreal Aflibercept Injection 2mg

Interventions

Intravitreal Aflibercept Injection 2mg DRUG

Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.

Also known as: Aflibercept; EYLEA®; VEGF Trap-Eye

Continued Q2 Week Treatment; Treat-And-Extend Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• A diagnosis of choroidal neovascularization related to age-related macular degeneration
• ETDRS refracted BCVA ≥ 20/200
• Prior treatment with any anti-VEGF agent for ≥ 12 months
• Prior treatment with at least five intravitreal aflibercept at the time of screening (week -2) with an average inter-treatment interval \<35 days
• Presence of persistent subretinal fluid with or without intraretinal fluid on OCT at most recent standard of care visit occurring 28-35 days following most recent intravitreal aflibercept injection
• Demonstration of definite improvement in overall retinal thickness and/or subretinal fluid on OCT based on evaluation of examining investigator at screening visit (week -2) 13-15 days following most recent standard of care visit
• o Note: screening OCT will be performed prior to dilation to allow for undilated ETDRS BCVA testing following confirmation of eligibility
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if:

• Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
• Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
• Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced diabetic retinopathy, advanced glaucoma)
• Active intraocular inflammation (grade trace or above) in the study eye
• Current vitreous hemorrhage in the study eye
• History of macula-involving rhegmatogenous retinal detachment or macular hole (Stage 2 - 4) in the study eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Aphakia in the study eye
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
• Use of systemic anti-VEGF medications within 6 months of screening visit
• History of cerebrovascular accident, myocardial infarction, ventricular arrhythmia, unstable angina, coronary or peripheral artery bypass or stenting within 6 months of day 0
• History of deep vein thrombosis or pulmonary embolus within 6 months of day 0
• Uncontrolled hypertension (\>160/100 on medical treatment)
• Pregnant or breast-feeding women
• Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception prior to the initial dose administration (baseline visit, week 0). Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.

Sponsors & Collaborators

• Tennessee Retina: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Schneider EW, Thomas MK, Recchia FM, Reichstein DA, Awh CC. SUSTAINED BIWEEKLY AFLIBERCEPT FOR REFRACTORY NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The Prospective TRISTAR Study. Retina. 2023 May 1;43(5):739-746. doi: 10.1097/IAE.0000000000003729.

  PMID: 36728874 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 16, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: July 1, 2019
• Last Updated: April 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)