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

March 10, 2014 updated by: Peter A Campochiaro, MD, Johns Hopkins University

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™

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute, Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Dose 0.2 ug/day Medidur implant
Drug: Fluocinolone Acetonide/Medidur
0.2 ug/day implant
Drug: Fluocinolone Acetonide/Medidur
0.5 ug/day implant
ACTIVE_COMPARATOR: 2
Dose 0.5 ug/day Medidur implant
Drug: Fluocinolone Acetonide/Medidur
0.2 ug/day implant
Drug: Fluocinolone Acetonide/Medidur
0.5 ug/day implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Visual Acuity
Time Frame: 6 mos
Visual acuity is measured using ETDRS charts at 4 meters.
6 mos

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Developing Cataracts
Time Frame: 6 mos
6 mos
Change in IOP From Baseline
Time Frame: 6 mos
IOP stands for intra ocular pressure
6 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Alimera Sciences
pSiVida Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (ESTIMATE)

January 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA 00012714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe