The MAP Study: FA/Medidur(TM)for AMD Pilot - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Alimera Sciences pSiVida Limited
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00605423

Purpose

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 triamicinolone 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.

Condition	Intervention	Phase
Age Related Macular Degeneration	Drug: Fluocinolone Acetonide/Medidur	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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™

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Mean change from baseline in visual acuity [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in lens opacity from baseline [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
Change in IOP from baseline [ Time Frame: constant throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dose 0.2 ug/day Medidur implant	Drug: Fluocinolone Acetonide/Medidur 0.2 ug/day implant
2: Active Comparator Dose 0.5 ug/day Medidur implant	Drug: Fluocinolone Acetonide/Medidur 0.5 ug/day implant

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605423

Contacts

Contact: Gulnar Hafiz, MD

410-502-0768

ghafiz1@jhmi.edu

Locations

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

Sponsors and Collaborators

Johns Hopkins University

Alimera Sciences

pSiVida Limited

Investigators

Principal Investigator:

Peter A Campochiaro, MD

Johns Hopkins University

More Information

Responsible Party:	The Johns Hopkins Hospital ( Peter A. Campochiaro, MD )
Study ID Numbers:	NA 00012714
Study First Received:	January 17, 2008
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00605423
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

AMD
Almera
Steroid

Macular
ARMD
AMD

Study placed in the following topic categories:

Fluocinolone Acetonide
Eye Diseases
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009