Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)

Alimera Sciences

Status and phase: Terminated; Phase 2

Conditions: Macular Edema; Retinal Vein Occlusion

Treatments: Drug: Fluocinolone Acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770770

C-01-08-006

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Fluocinolone Acetonide 0.2 µg/day

Experimental group

Description:

0.2 µg/day

Treatment:

Drug: Fluocinolone Acetonide

Drug: Fluocinolone Acetonide

Fluocinolone Acetonide 0.5 µg/day

Experimental group

Description:

0.5 µg/day

Treatment:

Drug: Fluocinolone Acetonide

Drug: Fluocinolone Acetonide