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

NCT00605423 | Completed Phase 2 Results DMC

• 1 other identifier: NA 00012714
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

AMD; Almera; Steroid; Macular; ARMD

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Visual Acuity

  Visual acuity is measured using ETDRS charts at 4 meters.

  6 mos

Secondary Outcomes (2)

• Number of Patients Developing Cataracts

  6 mos

• Change in IOP From Baseline

  6 mos

Study Arms (2)

1

ACTIVE COMPARATOR

Dose 0.2 ug/day Medidur implant

Drug: Fluocinolone Acetonide/Medidur

2

ACTIVE COMPARATOR

Dose 0.5 ug/day Medidur implant

Drug: Fluocinolone Acetonide/Medidur

Interventions

Fluocinolone Acetonide/Medidur DRUG

0.2 ug/day implant

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Alimera Sciences: collaborator
• pSiVida Limited: collaborator

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Peter Campochiaro, M.D.
• Organization: Johns Hopkins University

pcampo@jhmi.edu

Study Officials

• Peter A Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-03

Locations

US (1)