This trial is active, not recruiting.

Conditions macular edema, retinal vein occlusion
Treatments fluocinolone acetonide
Phase phase 2
Sponsor Alimera Sciences
Start date May 2009
End date October 2013
Trial size 20 participants
Trial identifier NCT00770770, C-01-08-006


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
0.2 µg/day
fluocinolone acetonide
0.2 µg/day
0.5 µg/day
fluocinolone acetonide
0.5 µg/day

Primary Outcomes

Visual Acuity
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Alimera Sciences.