Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

Withdrawn before enrolling · Phase 4

Conditions studied: Diabetic Macular Edema

In brief

The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4 intravitreal injections of 0.3 mg ranibizumab over 24 weeks.

Key facts

Study ID

NCT03059277

Run by

Southeast Clinical Research Associates, LLC

People needed

0

Starts

2018-06-01

Expected to finish

2020-09-30

Last updated by the study team

2018-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years with type 1 or type 2 diabetes
• Best Corrected Visual Acuity (by ETDRS) letter score in study eye ≤ 85 and ≥24 (approximate Snellen equivalent 20/20 to 20/320)
• Central retinal thickness on SD OCT at baseline visit of > 300 microns using Heidelberg Spectralis with definite evidence of intraretinal or subretinal fluid due to diabetic retinopathy in the CSF.
• Patients must have received at least four intravitreal ranibizumab 0.3 mg injections within 24 weeks prior to screening and failed to have had complete resolution of intraretinal or subretinal fluid on SD OCT and a CRT > 300 microns using Heidelberg Spectralis

You may not qualify if…

• Laser photocoagulation (panretinal or macular) in the study within 90 days of baseline
• Active high risk proliferative diabetic retinopathy (PDR)
• History of intravitreal corticosteroids within 4 months of baseline
• History of intravitreal bevacizumab within 24 weeks of baseline
• History of idiopathic or autoimmune uveitis in the study eye
• Cataract surgery in the study eye within 90 days of baseline
• Any intraocular surgery within 90 days of baseline
• Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect vision
• Evidence of active infection in either eye
• Uncontrolled glaucoma in the study eye defined as a pressure of > 25 mmHg on maximal medical therapy.

Where it is running

• Charlotte Eye Ear Nose and Throat Associates, PA — Charlotte, North Carolina, United States
• Charlotte Eye Ear Nose and Throat Associates, PA — Statesville, North Carolina, United States

Full record on ClinicalTrials.gov

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