Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Age-Related Macular Degeneration Clinical Trial

Official title:

A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00695318
• Other study ID #: C-01-08-004
• Status: Terminated
• Phase: Phase 2
• First received: June 9, 2008
• Last updated: May 11, 2015
• Start date: December 2008

Study information

• Verified date: May 2015
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Fluocinolone Acetonide
0.2 µg/Day in study eye + Sham in fellow eye
• Fluocinolone Acetonide
0.5 µg/Day in study eye +Sham in fellow eye

Locations

Country	Name	City	State
United States	Kresge Eye Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Size of Geographic Atrophy		24 months	No