MiCRVO
Research type
Research Study
Full title
A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Central Retinal Vein Occlusions
IRAS ID
180940
Contact name
Clare Bailey
Contact email
Sponsor organisation
The National Eye Institute
Eudract number
2017-001143-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 1 days
Research summary
Retinal vein occlusions (RVOs) are significant sources of vision loss, affecting mostly healthy people over 55 years of age. The common source of vision loss is the macular edema accompanying the retinal injury. Very recently, studies employing monthly anti-vascular endothelial growth factor (VEGF) treatments have demonstrated a benefit to this line of treatment; however, the duration of effectiveness appears to be short lived and the length of time needed for these monthly injections remains unknown. A histologic study of human retinas with RVOs found the presence of activated microglia. Microglia are capable of migrating through the retina to sites of inflammation to associate closely with neurons and the vasculature, and are key cellular players in the mediation of processes of chronic inflammation. For\nthese reasons, microglia represent a promising cellular target for forms of therapy that limit the deleterious inflammatory changes found in vein occlusions. Minocycline, a second-generation tetracycline, has been shown to exhibit anti-inflammatory properties, including microglia inhibition. The objective of this study is to investigate the safety and efficacy of minocycline as a microglia inhibitor in participants with central retinal vein occlusion.\n\nIn this pilot, double-masked, randomized, multi-center study, a minimum of 10 and a maximum of 20 participants will receive monthly bevacizumab injections for the first three months, followed by PRN dosing. In addition, participants will take an oral dose of 100 mg of minocycline or placebo twice daily for 24 months. During each monthly visit, participants will have their visual acuity measured and will undergo OCT testing to measure retinal thickness. At the Month 3 visit and thereafter, participants will be evaluated for “improvement” and “worsening” and will be eligible for additional bevacizumab treatment and/or investigational product depending on which criteria they fulfill. Additionally, at Month 12, participants will also be evaluated for “no improvement.”
REC name
South West - Central Bristol Research Ethics Committee
REC reference
17/SW/0202
Date of REC Opinion
16 Nov 2017
REC opinion
Further Information Favourable Opinion