Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

Phase 2

Terminated

• Conditions: Retinal Vein Occlusion; Macular Edema
• Interventions: Drug: Fluocinolone Acetonide

• Registration Number: NCT00770770
• Lead Sponsor: Alimera Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Study Start: 2009-05
• Primary Completion: 2013-10
• Results First Submitted: 2015-04-17
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-08
• Last Update Submitted: 2015-05-08
• Results First Posted: 2015-05-28
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluocinolone Acetonide 0.2 µg/day	Fluocinolone Acetonide	0.2 µg/day
Fluocinolone Acetonide 0.5 µg/day	Fluocinolone Acetonide	0.5 µg/day

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	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.

Trial Locations

Locations (3)

University of Kentucky Department of Ophthalmology; 🇺🇸 Lexington, Kentucky, United States

Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States