EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection

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.

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.