Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2013

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Visual Acuity
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alimera Sciences
  • Provider of Information About this Clinical Study
    • Sponsor

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