NCT03340610

IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab

Intravitreal Alflibercept Injection (IAI) for Persistent Diabetic Macular Edema (DME) After Treatment With Bevacizumab And Ranibizumab

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Southeast Retina Center, Georgia · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

Summary

This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled.

Detailed description

This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial. Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be enrolled. Starting at week 24, patients may be eligible to receive additional 2mg IAI (2q4) treatment if both of the following criteria is met and the investigator feels additional treatment would be beneficial: * Loss of \>5 letters from baseline or best previously recorded best corrected visual acuity (BCVA) * Presence of new or recurrent intraretinal fluid or subretinal fluid as assessed by SD OCT Starting at week 24, rescue therapy with macular laser photocoagulation may be administered if any the following criteria are met * Loss of \> 15 letters from baseline or best previously recorded BCVA and loss of acuity felt to be secondary to Diabetic Macular Edema (DME) and not from other cause (i.e., cataract, epiretinal membrane, vitreous hemorrhage, etc) and investigator feels patient would benefit from rescue therapy * Increase in SD OCT CSF \> 100 um from baseline or best previously recorded SD OCT CSF and investigator feels patient would benefit from rescue therapy. Every 4 week visit will include ETDRS BCVA, IOP measurement, Slit lamp biomicroscopy, Indirect ophthalmoscopy, Heidelberg Spectralis SD-OCT and evaluation for systemic and ocular adverse events. Fundus Photography and Wide field Optos fluorescein angiography will be performed at baseline and at week 20and week 52. STUDY DURATION: Approximately 52 weeks to the end of the study. Primary endpoint will be evaluated at week 52.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Alflibercept	Intravitreal Injection

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-12-01
• Completion: 2018-12-12
• First posted: 2017-11-13
• Last updated: 2019-05-24
• Results posted: 2019-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study