The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Alimera Sciences; pSiVida Limited
• Treatments: Fluocinolone Acetonide

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.