The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Fluocinolone Acetonide/Medidur; Fluocinolone Acetonide/Medidur
Intervention description: 0.2 ug/day implant; 0.5 ug/day implant
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 6.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; Almera; Steroid; Macular; ARMD

Summary:

      Treatment of exudative age-related macular degeneration has been significantly improved by
      the advent of Lucentis™( which provides improved vision rather than simply stabilization) is
      common; however, monthly injections may be required to maintain this effect. It is
      hypothesized that sustained release fluocinolone acetonide will allow maintenance of the
      improved vision with fewer Lucentis injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 50 or greater

          -  Treated with intraocular injections of Lucentis for at least 6 months and have reached
             a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA
             (worse or within one line better) or center subfield thickening (worse or within 30 um
             better).

          -  Best Corrected Visual Acuity 20/320 or better in the study eye

        Exclusion Criteria:

          -  Pregnant, lactating females or females of child bearing potential (unless using
             reliable contraception, i.e. double barrier, surgical sterilization, oral
             contraceptives, Norplant , intrauterine device (IUD).

          -  Glaucoma or ocular hypertension (defined as IOP > 21 mmHg or concurrent therapy at
             screening with IOP-lowering agents) in the study eye

          -  Laser or photodynamic therapy within 12 weeks of screening

          -  Any ocular surgery in the study eye within 12 weeks of screening

          -  Yag capsulotomy in the study eye within 15 days of screening

          -  Treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy
             other than Lucentis within 6 months prior to enrollment (e.g., triamcinolone
             injection, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed
             within 6 months prior to screening or at any time during the study.

          -  Any change in systemic steroid therapy within 3 months of screening

          -  Retinal or choroidal neovascularization due to ocular conditions other than AMD.

          -  Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any
             history of a potentially recurrent infection which could be activated by treatment
             with a steroid, (e.g., ocular herpes simplex virus).

          -  Known or suspected hypersensitivity to any of the ingredients of Lucentis, the
             investigational product or to other corticosteroids.

          -  History of vitrectomy in the study eye

          -  History of uncontrolled IOP elevation with steroid use that did not respond to topical
             therapy

          -  History or presence of any disease or condition (malignancy) that in the
             investigator's opinion would preclude study treatment or follow-up

          -  Any lens opacity which impairs visualization of the posterior pole

          -  Participation in another clinical trial within 12 weeks before the screening visit or
             during the study

          -  Subjects who are a poor medical risk because of other systemic diseases or active
             uncontrolled infections.