UnknownPhase 2

Evaluation of Treatment of High riSk proLiferative Diabetic retinopathY With Intravitreal Aflibercept injectioN

30 participantsStarted 2016-01

Plain-language summary

To assess the safety and efficacy of intravitreal aflibercept injection in the regression of retinal neovascularization secondary to high-risk PDR. To characterize baseline/post-induction/maintenance levels of proinflammatory mediators in patients with high-risk PDR

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
✓. 18 years or older males and females with a history of diabetes mellitus and ability to sign informed consent
✓. ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit
✓. Eyes with mild pre-retinal hemorrhage or mild vitreous hemorrhage that does not interfere with clear visualization of the macula and optic disc are eligible for this study

Exclusion criteria

✕. Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc
✕. Presence of either:

What they're measuring

Assess ocular and non-ocular adverse events

Timeframe: 12 Months

Trial details

NCT IDNCT02630277

SponsorValley Retina Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

Contact for this trial

Victor H. Gonzalez, MD

956-631-8875 research@vritx.com

View on ClinicalTrials.gov More Proliferative Diabetic Retinopathy trials