Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

Macular Edema Clinical Trial

— FAVOR  

Official title:

A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00770770
• Other study ID #: C-01-08-006
• Status: Terminated
• Phase: Phase 2
• First received: October 9, 2008
• Last updated: May 8, 2015
• Start date: May 2009

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 assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

• Central subfield thickness > 300 µm

• BCVA of = 24 and = 68 letters

• Males and non-pregnant females 18 years and over

Exclusion Criteria:

• Macular edema secondary to any condition other than RVO

• Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye

• Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss

• Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents)

• Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye

• Any change in systemic steroid therapy within 3 months of screening

• History of vitrectomy in the study eye

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Fluocinolone Acetonide
0.2 µg/day
• Fluocinolone Acetonide
0.5 µg/day

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Cole Eye Institute	Cleveland	Ohio
United States	University of Kentucky Department of Ophthalmology	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.	3 months	Yes