EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection
Condition: Macular Degeneration; Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Intravitreal aflibercept injection
Intervention description: 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.
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: AMD; Wet AMD; Macular degeneration; Wet macular degeneration; Neovascularization; Retina; Retinal degeneration

Summary:

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

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.