To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
Condition: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Intervention: Alfilbercept
Intervention description: All patients will receive 2.0 mg intravitreal aflibercept injection.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal
      aflibercept injection in patients who have been previously treated for AMD and have
      persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 50 years

          -  Choroidal neovascularization secondary to AMD

          -  Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS
             chart

          -  Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT
             following at least four anti-VEGF treatments within six months before enrollment and a
             maximum of 5 years of years of treatment for neovascular AMD

          -  Documentation of presence of subretinal fluid and/or cystoid macular edema less than
             30 days since last treatment

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or lactation

          -  Premenopausal women not using adequate contraception. The following are considered
             effective means of contraception: surgical sterilization or use of oral
             contraceptives, barrier contraception with either a condom or diaphragm in conjunction
             with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

          -  Participation in another simultaneous medical investigation or trial

          -  Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL

          -  Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.

          -  Presence of significant subfoveal fibrosis or atrophy.

          -  Prior treatment with intravitreal aflibercept injection

          -  Prior treatment with triamcinolone in the study eye within 6 months of BSL.

          -  Prior treatment with dexamethasone in the study eye within 30 days prior to BSL

          -  Intraocular surgery (including cataract surgery) in the study eye within 2 months
             preceding BSL

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD in the study eye

          -  Active intraocular inflammation (grade trace or above) in the study eye

          -  Current vitreous hemorrhage in the study eye

          -  History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the
             study eye

          -  Ocular or periocular infection

          -  Active severe intraocular inflammation

          -  Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment
             with anti-glaucoma medication)

          -  History of cerebral vascular accident, myocardial infarction, transient ischemic
             attacks within 3 months of study enrollment.

          -  History of allergy to fluorescein, ICG or iodine, not amenable to treatment

          -  Known hypersensitivity to aflibercept or to any of the excipients