Clinical trial NCT00605423: The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Keywords: AMD
Almera
Steroid
Macular
ARMD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Alimera Sciences
name: pSiVida Limited
First posted: 2008-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Mean Change From Baseline in Visual Acuity
timeFrame: 6 mos
Secondary outcomes:
measure: Number of Patients Developing Cataracts
timeFrame: 6 mos
measure: Change in IOP From Baseline
timeFrame: 6 mos
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute, Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter A Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: