Study for Recalcitrant Age Related Macular Degeneration
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: aflibercept 2.0 mg
Intervention description: Intravitreal aflibercept injection 2.0 mg
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age related Macular Degeneration; Recalcitrant Age Related Macular Degeneration

Summary:

      50 Patients with recalcitrant exudative age-related macular degeneration with a history of
      retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and
      subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of
      ranibizumab.
    

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

          -  History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD

          -  Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS
             chart

        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 28 days of baseline

          -  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 Baseline

          -  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

          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either
             eye

          -  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

          -  History of retinal pigment epithelial tear or rip