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

Condition(s) targeted: Age Related Macular Degeneration

Intervention: Fluocinolone Acetonide/Medidur (Drug); Fluocinolone Acetonide/Medidur (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Peter A Campochiaro, MD, Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Gulnar Hafiz, MD, Phone: 410-502-0768, Email: ghafiz1@jhmi.edu

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.

Official title: A Single Masked, Randomized Comparison of the Safety and Efficacy of 0.2 and 0.5 µg/Day Fluocinolone Acetonide/Medidur™ in Patients With Exudative Age Related Macular Degeneration Who Have Received Lucentis™

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Mean change from baseline in visual acuity

Secondary outcome:

change in lens opacity from baseline

Change in IOP from baseline

Detailed description: 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. The use of the glucocorticoids such as triamcinolone acetonide as adjunct treatment for exudative age-related macular degeneration has been reported to enhance the efficacy of photodynamic therapy with Visudyne® (verteporphin for injection). It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. This study is a pilot phase 2b study to test this hypothesis. The safety assessments will continue through 36 months. This study will compare the safety 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Gulnar Hafiz, MD, Phone: 410-502-0768, Email: ghafiz1@jhmi.edu

Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Gulnar Hafiz, MD, MPH, Phone: 410-502-0768, Email: ghafiz1@jhmi.edu
Peter A Campochiaro, MD, Principal Investigator

Starting date: January 2008
Last updated: May 25, 2010