EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection

NCT02689518 | Completed Phase 4 Results

• 1 other identifier: EAGLE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)

Conditions

Macular Degeneration; Wet Macular Degeneration

Keywords

AMD; Wet AMD; Macular degeneration; Wet macular degeneration; Neovascularization; Retina; Retinal degeneration

Outcome Measures

Primary Outcomes (1)

• Anatomic Response

  The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes: Early response (at Month 3) - o On optical coherence tomography(SD-OCT) * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \<300 um, OR * Absence of retinal fluid Later response (at Month 12) - o On SD-OCT * Reduction in central retinal thickness by ≥ 50%, OR * Central retinal thickness \< 300 um, OR * Absence of retinal fluid Poor response, defined as no reduction of fluid or central retinal thickness at Month 12.

  12 Months

Secondary Outcomes (1)

• Visual/Treatment Response

  12 Months

Other Outcomes (1)

• Safety - Incidence and Severity of Ocular and Non-ocular Adverse Events

  12 Months

Study Arms (1)

Treatment - On-Label

OTHER

On-label intravitreal aflibercept (Eylea) injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks (2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months

Drug: Intravitreal aflibercept injection

Interventions

Intravitreal aflibercept injection DRUG

Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.

Also known as: Eylea

Treatment - On-Label

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• Naïve neovascular wet-AMD (has not received treatment before)
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent

You may not qualify if:

• Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
• Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
• History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
• Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either 4.1 require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or 4.2 if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
• Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
• Current vitreous hemorrhage in the study eye
• History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Aphakia, ACIOL, or unstable PCIOL
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
• Pregnant or breast-feeding women
• Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (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 \[IUD\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
• Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated \*Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Sponsors & Collaborators

• University of California, San Diego: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Shiley Eye Center

La Jolla, California, 92126, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Neovascularization, Pathologic; Retinal Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary

Limitations and Caveats

Principal Investigator is no longer associated with the institution. All efforts were exhausted to obtain the data but no data could be found.

Results Point of Contact

• Title: Professor Michael Goldbaum
• Organization: University of California San Diego

mgoldbaum@ucsd.edu

858 534 3516

Study Officials

• Michael Goldbaum, M.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor of Ophthalmology in Residence

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: February 24, 2016
• Study Start: April 1, 2014
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: March 25, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-03

Locations

US (1)