NCT00695318

Brief Summary

This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 29, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

4.8 years

First QC Date

June 9, 2008

Results QC Date

April 17, 2015

Last Update Submit

May 11, 2015

Conditions

Age-Related Macular Degeneration

Keywords

AMDAge-Related Macular DegenerationGeographic AtrophyGA

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Size of Geographic Atrophy

    24 months

Study Arms (2)

A, 2, I 0.2 µg/Day + Sham

EXPERIMENTAL

0.2 µg/Day

Drug: Fluocinolone Acetonide

A, 2, II 0.5 µg/Day + Sham

EXPERIMENTAL

0.5 µg/Day

Drug: Fluocinolone Acetonide

Interventions

Fluocinolone AcetonideDRUG

0.2 µg/Day in study eye + Sham in fellow eye

A, 2, I 0.2 µg/Day + Sham

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
  • Males and non-pregnant females 55 years old or older

You may not qualify if:

  • GA secondary to any condition other than AMD in either eye
  • History of or current CNV in either eye or the need for anti-angiogenic therapy
  • Glaucoma or ocular hypertension (IOP \> 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
  • Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
  • Any change in systemic steroid therapy within 3 months of screening
  • History of vitrectomy in either eye
  • Any ocular surgery within 12 weeks of screening in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kresge Eye Institute

Detroit, Michigan, United States

Location

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Kathleen Billman, Senior Director, Scientific Affairs
Organization
Alimera Sciences, Inc.
kathleen.billman@alimerasciences.com
678-527-1302

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2013

Last Updated

May 29, 2015

Results First Posted

May 29, 2015

Record last verified: 2015-05

Locations

US(1)