Clinical trial NCT02689518: EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
Official title: Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Degeneration
Wet Macular Degeneration
Keywords: AMD
Wet AMD
Macular degeneration
Wet macular degeneration
Neovascularization
Retina
Retinal degeneration
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2016-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Clinical and genetic assessment of treatment response in patients with age-related macular degeneration using intravitreal aflibercept injection. This study seeks to determine if different genetic polymorphisms of vascular endothelial growth factor A (VEGF-A) and HtrA serine peptidase 1(HTRA1) and other genes correlate to the response to intravitreal aflibercept injection therapy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous therapy in study eye for AMD or other retinal disease which may be used in the treatment of AMD
2. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
3. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
4. 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
5. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
6. Current vitreous hemorrhage in the study eye
7. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
8. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
9. Aphakia, ACIOL, or unstable PCIOL
10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
11. Pregnant or breast-feeding women
12. 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)
13. 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.

Primary outcomes:
measure: Anatomic Response
timeFrame: 12 Months
Secondary outcomes:
measure: Visual/Treatment Response
timeFrame: 12 Months
Other outcomes:
measure: Safety - Incidence and Severity of Ocular and Non-ocular Adverse Events
timeFrame: 12 Months
Locations:
city: La Jolla
country: United States
facility: Shiley Eye Center
state: California
Study officials:
affiliation: UCSD
name: Michael Goldbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: